Clinical Affairs Manager – In Vitro Diagnostics (Remote, South San Francisco, CA, USA)
Location: South San Francisco, California, United States (Fully Remote)
Job Type: Full-Time
Division: Regulatory & Clinical Affairs
Job ID: R-01332548
About Thermo Fisher Scientific – Quality & Clinical Excellence
Thermo Fisher Scientific is a global leader in life sciences and diagnostic solutions, committed to improving patient outcomes worldwide. Our quality and clinical teams play a vital role in ensuring that our in vitro diagnostics (IVDs) are accurate, safe, and effective. By joining our team, you will contribute to FDA submissions, regulatory compliance, and clinical study oversight, helping bring innovative diagnostics to the patients who need them most.
We offer an environment that supports professional growth, cross-functional collaboration, and career development, with opportunities to make a meaningful impact in the medical device and diagnostics industry.
Role Overview
We are seeking a Clinical Affairs Manager – In Vitro Diagnostics to support clinical study planning, core team operations, and CRO management. This role is fully remote, providing flexibility while maintaining a central role in project delivery and regulatory compliance.
As a Clinical Affairs Manager, you will act as the primary clinical representative for core project teams, oversee interactions with external partners and CROs, and ensure that clinical studies align with Good Clinical Practices (GCP), FDA requirements, and global regulatory standards.
Key Responsibilities
Serve as the clinical studies representative for project core teams.
Participate in laboratory assessments, lab selection, and study planning.
Collaborate closely with regulatory teams and project management during study planning, coordination, and execution.
Document clinical study plans and reports for inclusion in the Design History File (DHF).
Act as the primary interface with pharmaceutical partners regarding IVD study requirements.
Facilitate internal and external planning meetings for clinical studies.
Coordinate activities with CROs to ensure timeline adherence and regulatory compliance.
Escalate clinical study issues in real time to project and regulatory management.
Mentor and train junior clinical staff to develop team expertise.
Required Qualifications & Experience
Bachelor’s degree in Biology, Chemistry, Bioengineering, or a related scientific field.
Minimum 4 years of experience in the in vitro diagnostic (IVD) or medical device industry. Companion diagnostics experience is highly desirable.
4+ years managing clinical studies, either in-house or with external CROs.
Solid understanding of Good Clinical Practices (GCP).
Experience collaborating with multi-functional project teams.
Digital literacy, including spreadsheets, databases, and document processing.
Strong interpersonal and communication skills; ability to work with internal teams, CROs, and pharmaceutical partners.
Willingness to travel occasionally for site visits or team meetings.
Preferred Qualifications:
Clinical Research Professional Certification (CCRP) or equivalent coursework in GCP.
Experience in companion diagnostics studies.
Key Skills & Competencies
Ability to manage projects with distributed teams across multiple sites.
Strong problem-solving and decision-making skills under tight timelines.
High energy, assertive communication, and ability to work effectively under pressure.
Mentoring and leadership skills to guide junior clinical staff.
Strong organizational skills and attention to detail to ensure regulatory compliance and study quality.
Benefits & Compensation
Salary Range: $112,500 – $130,000 (California-based, fully remote).
Eligible for annual performance-based bonus.
Comprehensive Total Rewards package including:
National medical, dental, and vision coverage with wellness incentives
Paid Time Off (120+ hours), 10 paid holidays, and parental leave
Retirement savings programs including 401(k) plan
Employees’ Stock Purchase Plan (ESPP)
Tuition reimbursement, commuter benefits, and family support programs
Short- and long-term disability, accident and life insurance
Thermo Fisher Scientific fosters an innovative, collaborative, and forward-thinking culture, offering outstanding opportunities for career growth and global impact in clinical research and diagnostics.
Why Join Thermo Fisher Scientific?
This role offers the opportunity to:
Lead clinical study planning and CRO management for in vitro diagnostic products.
Ensure regulatory compliance for FDA and global submissions.
Collaborate with cross-functional teams on high-impact clinical projects.
Mentor and develop junior staff, shaping the future of clinical affairs.
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Siliguri |Illinois :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
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Auckland |New Zealand :
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Barcelona |Madrid :
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Manila |Croatia :
Croatia |Zagreb :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Seoul |Kazakhstan :
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Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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