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Thermo Fisher Scientific

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ED/VP Medical Science & Strategy - Metabolic
Thermo Fisher Scientific · Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. We seek an Executive Director/Vice President for our Medical Science and Strategy Team - Metabolic. The role can be based in the EMEA region but will require travel to China (or relocation could be considered). The position requires proven abilities to drive both strategic and measurable business outcomes. The incumbent’s Metabolic track record expertise is required to be extensive and ensure recognition as peer of their Pharmaceutical Industry equivalents. This position is playing a key part in the future success of the PPD clinical research business of Thermo Fisher Scientific, as it seeks to continue its track record of successful growth and expand Industry leading position in Metabolic. Medical Science & Strategy physicians are subject matter experts who support sales for proposals and bid defences, engaging clients senior medical / scientific leadership in discussions and training internal staff on medical and therapeutic requirements of the proposals. The role comprises four major functions: • First, the incumbent is responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs), including: • Development strategy and regulatory issues • Drug class issues • Protocol and indication considerations, including safety • Team education on indication • Interactions with client’s physicians and / or client area indication leaders prior to and during bid defences • Identifying business opportunities for the PPD clinical research business • Secondly, the incumbent is responsible for supporting outstanding input into other areas of the PPD clinical research business activities, including: • Pro-active client engagement: peer-to-peer interactions with therapeutic area leaders and senior directors of companies whose portfolio contains drugs of business interest • Strategic alliance development & support • Client governance and advisory boards • Through PPD’s consulting practice, the incumbent will provide Industry gold standard product development plans, and top-level design of clinical trial protocols that are required in the development plan. • Thirdly, the incumbent will be responsible for providing therapeutic and developmental expertise to internal teams, including: • Indication specific training for clinical teams • Guidance during clinical trials executions • Investigator Brochure, clinical study report, NDA / MAA clinical packages development, and other regulatory briefing documents authoring and review • Contribute to design and reporting of feasibility studies • Liaise with investigators and KOLs • Mentor and supervise clinical scientists • Finally, the incumbent will participate in multidisciplinary teams and working groups to contribute to innovative initiatives based on their specific knowledge, expertise and interest. Minimum Qualifications: • MD or equivalent required • Certified in a medical specialty or subspecialty related to metabolic disorders (i.e. Endocrinology, Cardiology, Internal Medicine) with at least 5+ years’ experience in pharmaceutical industry leading clinical development of at least one asset from discovery through registration. • Proficient in spoken and written English and Mandarin • Active medical license preferred but not required. Knowledge, Skills and Abilities: • Able to work in a matrix organization. • Able to demonstrate the following key high-level high-performance behaviors: decisive, customer driven, flexible thinking, smart-risk taking and continuous improvement. • Leads, influences and motivates staff within and across departments. • Strong in presenting and communicating complex information clearly. • Able to deal with sensitive and confidential issues. • Possesses a “can do” attitude and is capable of implementing and following through on activities / projects. • Flexibility to travel domestically and internationally What we offer: • Full time position • Competitive salary and benefits • Work diversity, exposure to several assets in different stages of clinical development from several clients • Mentorship and training • Exciting work environment About the PPD clinical research business of Thermo Fisher Scientific: Our mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today!

Medical Science Liaison
TF
ED/VP Medical Science & Strategy - Oncology
Thermo Fisher Scientific · Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. We seek an Executive Director/Vice President for our Medical Science and Strategy Team - Oncology. The role can be based in the EMEA region but will require travel to China (or relocation could be considered). The position requires proven abilities to drive both strategic and measurable business outcomes. The incumbent’s Oncology track record expertise is required to be extensive and ensure recognition as peer of their Pharmaceutical Industry equivalents. This position is playing a key part in the future success of the PPD clinical research business of Thermo Fisher Scientific, as it seeks to continue its track record of successful growth and expand Industry leading position in Oncology. Medical Science & Strategy physicians are subject matter experts who support sales for proposals and bid defences, engaging clients senior medical / scientific leadership in discussions and training internal staff on medical and therapeutic requirements of the proposals. The role comprises four major functions: • First, the incumbent is responsible for ensuring the highest possible quality of input into significant requests for proposals (RFPs), including: • Development strategy and regulatory issues • Drug class issues • Protocol and indication considerations, including safety • Team education on indication • Interactions with client’s physicians and / or client area indication leaders prior to and during bid defences • Identifying business opportunities for the PPD clinical research business • Secondly, the incumbent is responsible for supporting outstanding input into other areas of the PPD clinical research business activities, including: • Pro-active client engagement: peer-to-peer interactions with therapeutic area leaders and senior directors of companies whose portfolio contains drugs of business interest • Strategic alliance development & support • Client governance and advisory boards • Through PPD’s consulting practice, the incumbent will provide Industry gold standard product development plans, and top-level design of clinical trial protocols that are required in the development plan. • Thirdly, the incumbent will be responsible for providing therapeutic and developmental expertise to internal teams, including: • Indication specific training for clinical teams • Guidance during clinical trials executions • Investigator Brochure, clinical study report, NDA / MAA clinical packages development, and other regulatory briefing documents authoring and review • Contribute to design and reporting of feasibility studies • Liaise with investigators and KOLs • Mentor and supervise clinical scientists • Finally, the incumbent will participate in multidisciplinary teams and working groups to contribute to innovative initiatives based on their specific knowledge, expertise and interest. Minimum Qualifications: • MD or equivalent required • Certified Oncologist with at least 5+ years’ experience in pharmaceutical industry leading clinical development of at least one asset from discovery through registration. • Proficient in spoken and written English and Mandarin • Active medical license preferred but not required. Knowledge, Skills and Abilities: • Able to work in a matrix organization. • Able to demonstrate the following key high-level high-performance behaviors: decisive, customer driven, flexible thinking, smart-risk taking and continuous improvement. • Leads, influences and motivates staff within and across departments. • Strong in presenting and communicating complex information clearly. • Able to deal with sensitive and confidential issues. • Possesses a “can do” attitude and is capable of implementing and following through on activities / projects. • Flexibility to travel domestically and internationally What we offer: • Full time position • Competitive salary and benefits • Work diversity, exposure to several assets in different stages of clinical development from several clients • Mentorship and training • Exciting work environment About the PPD clinical research business of Thermo Fisher Scientific: Our mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today!

Medical Science Liaison
TF
Procurement/Sourcing Specialist II
Thermo Fisher Scientific · Rosh Pinna

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: Join our collaborative procurement team and make a meaningful impact on providing scientific solutions. As a Procurement/Sourcing Specialist II, you'll create value across our supplier network while ensuring uninterrupted supply of critical materials and services. Working with cross-functional teams, you'll negotiate contracts, implement cost-saving initiatives, and build strategic supplier relationships that support our mission of enabling customers to make the world healthier, cleaner and safer. Your role will involve managing supplier portfolios, executing sourcing strategies, analyzing market intelligence, and ensuring on-time delivery of materials to meet production demands. You'll collaborate with stakeholders across manufacturing, engineering, quality, and planning teams to optimize our supply chain and support continuous improvement. This position offers excellent opportunities for professional growth while contributing to scientific advances. REQUIREMENTS: • Advanced Degree with no prior experience, OR Bachelor's Degree plus 1-2 years of procurement/sourcing experience in manufacturing or regulated industry environments • Advanced supply chain certifications (APICS, CPIM, CSCP) preferred • Strong analytical and negotiation skills with proven ability to achieve cost savings • Advanced proficiency in ERP systems (SAP, Oracle, etc.) and Microsoft Office Suite • Excellence in supplier relationship management and contract negotiations • Experience with strategic sourcing, RFx processes, and supplier performance metrics • Strong project management capabilities and ability to guide cross-functional initiatives • Demonstrated ability to work independently and collaboratively in a matrix organization • Strong written and verbal communication skills • Advanced English language proficiency required; additional languages beneficial • Ability to analyze market trends and develop risk mitigation strategies • Experience with continuous improvement methodologies (Lean, Six Sigma) • Strong attention to detail and ability to manage multiple priorities • Knowledge of regulatory requirements (GMP, ISO) preferred • Available for occasional domestic/international travel (10-25%)

Buyer
TF
FSP Country Approval Specialist
Thermo Fisher Scientific · Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals. What You’ll Do: • Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. • Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients. • Provides project specific local SIA services and coordination of these projects. • May have contact with investigators for submission related activities. • Key-contact at country level for either Ethical or Regulatory submission-related activities. • Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation. • Achieves PPD’s target cycle times for site. • May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. • May develop country specific Patient Information Sheet/Informed Consent form documents. • May assist with grant budgets(s) and payment schedules negotiations with sites. • Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. • Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner. • Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. • Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Effective oral and written communication skills • Excellent interpersonal skills • Strong attention to detail and quality of documentation • Good negotiation skills • Good computer skills and the ability to learn appropriate software • Good English language and grammar skills • Basic medical/therapeutic area and medical terminology knowledge • Ability to work in a team environment or independently, under direction, as required • Basic organizational and planning skills • Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations Working Conditions and Environment: • Work is performed in an office/ laboratory and/or a clinical environment. • Exposure to biological fluids with potential exposure to infectious organisms. • Exposure to electrical office equipment. • Personal protective equipment required such as protective eyewear, garments and gloves

Country Approval Specialist
TF
Clinical Research Associate (CRA)
Thermo Fisher Scientific · Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. We have an exciting opportunity for Clinical Research Associate (CRA)! Summarized Purpose: Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix. Essential Functions: • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. • Assess investigational product through physical inventory and records review. • Documents observations in reports and letters in a timely manner using approved business writing standards. • Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. • May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. • Conducts monitoring tasks in accordance with the approved monitoring plan. • Participates in the investigator payment process. • Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required. • Travel requirement higher than 75 %. Qualifications: Education and Experience: • Bachelor's degree in a life sciences related field • Clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (at least 1 year) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. • Valid driver's license where applicable. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Basic medical/therapeutic area knowledge and understanding of medical terminology • Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Good interpersonal skills • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues • Good organizational and time management skills • Ability to remain flexible and adaptable in a wide range of scenarios • Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English and Hebrew language and grammar skills Why Join Us: We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development programme, ensuring you reach your potential. What we offer: As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD® clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Our 4i Values: Integrity – Innovation – Intensity – Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you! Apply today to help us deliver tomorrow’s breakthrough.

Clinical Research Associate
TF
FSP Clinical Trial Coordinator
Thermo Fisher Scientific · Tel Aviv-Yafo

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Trial Coord, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing CRG personnel, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed. What You’ll Do: • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix. • Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s). • Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads. • Provides system support (i.e., Activate & eTMF) and ensures system databases are always current. • Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members. • Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. • Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. • Assists with study-specific translation materials and translation QC upon request. • Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided. • Where applicable, conducts on-site feasibility visits (Asia Pac only). • May support scheduling of client and/or internal meetings. • May review and track of local regulatory documents. • May provide system support (i.e., Activate & eTMF). May support RBM activities. • May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s). • Transmits documents to client and centralized IRB/IEC. • Maintains vendor trackers. • Supports start-up team in Regulatory submissions. • Works directly with sites to obtain documents related to site selection. • Assists the project team with the preparation of regulatory compliance review packages. • Provides support as needed to coordinate with internal departments, ensuring site start-up activities within the site activation critical path are aligned. • May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel. • Documents in real time all communication, attempts an follow up associated with site contact and survey responses. • Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked. • Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks. • Ensures an efficient, effective plan is in place for site contact and follow up. Ensure compliance with the plan and escalate concerns/non-compliance to management. • May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harness this knowledge base when performing local tiering of sites. • Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information. • Contributes to the development and roll-out of global strategic feasibility processes and best practices. • Trains new personnel in processes and systems. • Utilizes local knowledge to contribute to the identification and development of new sites. Education and Experience Requirements: • High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. • Bachelor's degree preferred. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Flexibility to reprioritize workload to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout • Good English language and grammar skills and proficient local language skills as needed • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete the organizations clinical training program • Self-motivated, positive attitude and good interpersonal skills • Effective oral and written communication skills • Good interpersonal skills • Essential judgment and decision-making skills • Capable of accurately following project work instructions • Good negotiation skills • Independent thinker • Ability to manage risk and perform risk escalation appropriately Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/ and/or home office environment with exposure to electrical office equipment. • Occasional drives to site locations. Potential Occasional travel required.

Clinical Trial Manager
TF
Field Service Engineer – Analytical Instruments
Thermo Fisher Scientific · Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials Job Description Thermo Fisher Integrated Solutions Israel is the Israel subsidiary of Thermo Fisher Scientific, the world’s leading life sciences solutions company, with a mission to enable our customers to make the world healthier, cleaner, and safer. As a newly established and growing subsidiary, we are building a strong local presence to support Israel’s dynamic life sciences ecosystem. As part of the Thermo Fisher Scientific team, you will have a hands-on role in delivering innovative technologies, services, and solutions directly to customers, while collaborating closely with global teams and leveraging the full strength of Thermo Fisher’s industry-leading brands. This is a unique opportunity to contribute locally while being part of a global mission that advances science and improves lives every day. Thermo Fisher’s comprehensive product portfolio, integrated software solutions and global service network empower scientists across academic and clinical research, pharmaceutical and biopharmaceutical development, environmental and applied markets, and industry to generate actionable data with confidence. By combining innovative instrumentation with end‑to‑end support, we help customers accelerate discoveries and maintain the highest standards of quality and compliance. DESCRIPTION: As a Field Service Engineer, you will provide expert installation, maintenance, troubleshooting, and repair services for advanced analytical equipment. Working with cutting-edge technology, you will deliver high-quality technical support while building strong relationships with customers across research institutions, universities, and industrial facilities. You will diagnose and resolve complex technical issues, perform preventive maintenance, and provide user training to ensure optimal system performance and customer satisfaction. This role offers excellent opportunities for professional growth and development within an organization dedicated to enabling our customers to make the world healthier, cleaner, and safer. Key Responsibilities • • Install, maintain, troubleshoot, repair, and support analytical instruments, equipment, and associated systems. • Interact directly with customers and customer care representatives to coordinate and manage service activities and logistics. • Manage and complete assigned field service tasks independently and efficiently. • Diagnose technical issues using structured analytical troubleshooting and provide appropriate solutions and recommendations. • Perform preventive maintenance, corrective maintenance, system upgrades, and other technical service activities as required. • Ensure equipment is operating according to applicable specifications and customer requirements. • Ensure compliance with Thermo Fisher Scientific safety, quality, and regulatory standards. • Generate accurate, complete, and timely service documentation and reports. • Collaborate with customers to understand their technical and operational needs and provide appropriate service solutions. • Work closely with local and global technical support, application, commercial, and service teams as required. • Participate in work schedule and service planning with colleagues and management. • Identify potential customer needs and provide relevant sales leads and feedback to commercial and support teams. • Maintain and continuously develop technical knowledge of supported products, technologies, software, and related IT environments. • Participate in technical and product training as required to support current and future analytical instrument platforms. Requirements • • 5+ years of relevant technical, field service, engineering, or instrumentation experience. • Bachelor’s degree or higher in mechatronics, electronics, electrical engineering, mechanical engineering, engineering, or another relevant technical discipline, or equivalent practical experience. • Experience working with scientific, laboratory, analytical, industrial, or other complex technical instrumentation is an advantage. • Experience with Thermo Fisher Scientific instruments or technologies is an advantage. • Strong analytical troubleshooting and problem-solving skills. • Strong hands-on technical capabilities and ability to work with complex electromechanical systems. • Interest in technology, software, networking, and IT-related systems. • Ability to learn and support new technologies and instrument platforms. • Effective technical communication and interpersonal skills. • Strong customer-service orientation and ability to work effectively in a customer-facing environment. • Ability to work independently while collaborating effectively with local and global teams. • Fluent in Hebrew and English. • Valid Israeli driving license. • Willingness and ability to travel extensively to customer sites. • Working week is Sunday - Thursday Join our team and be part of a world-class organization dedicated to making a positive impact on the world. Apply today!

Field Service Engineer
TF
FSP Clinical Research Associate I/ Clinical Research Associate II
Thermo Fisher Scientific · Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. DESCRIPTION As part of our global team, you'll have the opportunity to perform and coordinate different aspects of the clinical monitoring and site management process. As a Clinical Research Associate I, you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You'll Do: • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable. • Participates in investigator meetings as necessary. May help to identify potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials. • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications. • Provides trial status tracking and progress update reports to the team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). • Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. • Maintains and completes administrative tasks such as expense reports and timesheets in a timely manner. • Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members. Contributes to other project work and initiatives for process improvement, as required. REQUIREMENTS Education and Experience Requirements: • Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • 1-2 years of experience as a Clinical Research Associate / Monitor • Valid driver's license where applicable In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Basic medical/therapeutic area knowledge and understanding of medical terminology • Ability to attain and maintain a working knowledge of ICH GCPs and applicable regulations and procedural documents • Good oral and written communication skills, with the ability to communicate effectively with medical personnel • Good interpersonal skills • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues • Good organizational and time management skills • Ability to remain flexibile and adaptable in a wide range of scenarios • Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving • Ability to manage Risk Based Monitoring concepts and processes • Ability to work in a team or independently as required • Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software • Good English language and grammar skills Working Conditions and Environment: • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. • Exposure to biological fluids with potential exposure to infectious organisms. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions.

Clinical Research Associate
TF
CTM/Sr CTM - FSP - EMEA
Thermo Fisher Scientific · Remote

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Trial Manager - Make an Impact at the Forefront of Innovation The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy. What You'll Do: • Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects. • Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. • Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department. • Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. • May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. • May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees. • May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements. Education & Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, Abilities: • Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams • Good planning and organizational skills to enable effective prioritization of workload • Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization • Capable of working effectively in a changing environment with complex/ambiguous situations • Familiarity with the practices, processes, and requirements of clinical monitoring • Good judgment and decision making skills • Effective oral and written communication skills, including English language proficiency • Capable of evaluating workload against project budget and adjusting resources accordingly • Sound financial acument and knowledge of budgeting, forecasting and fiscal management • Strong attention to detail • Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. • Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. Working Conditions and Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Frequently drives to site locations and frequently travels both domestic and international. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.

Clinical Trial Manager

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