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AI Summary

The Clinical Vendor Oversight Specialist manages third-party vendor relationships throughout the clinical trial lifecycle to ensure study deliverables meet quality and timeline standards. They lead vendor performance monitoring, risk mitigation, and cross-functional collaboration to ensure compliance with regulatory requirements and internal policies.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Clinical Vendor Oversight Specialist

Make an impact. Advance science. Grow your career.

At Thermo Fisher Scientific, you'll be part of a global team committed to making the world healthier, cleaner, and safer. Every day, our colleagues contribute to groundbreaking research and innovative clinical solutions that help accelerate the development of life-changing therapies for patients around the world.

If you're passionate about clinical operations, vendor management, and driving operational excellence, this is your opportunity to join a collaborative, high-performing team where your work truly makes a difference.

What you'll do

As a Clinical Vendor Oversight Specialist, you will play a key role in ensuring the successful execution of clinical studies by managing relationships with third-party vendors and collaborating closely with cross-functional teams.

Your responsibilities will include:

  • Lead the day-to-day oversight and management of third-party vendors throughout the clinical trial lifecycle.
  • Develop study-specific vendor management plans, Vendor Oversight Plans, and required vendor documentation in collaboration with Study Management Teams (SMTs), Functional Subject Matter Experts (SMEs), Procurement, and the Biogen FSP Oversight Manager.
  • Create, collect, and finalize study vendor specifications in partnership with functional SMEs.
  • Ensure study-level vendor timelines, deliverables, and contractual commitments are clearly defined, monitored, and achieved.
  • Maintain regular communication with Study Management Teams by providing updates on study progress, vendor performance, risks, and issue tracking.
  • Monitor vendor performance through KPIs, governance meetings, and performance management reviews, driving continuous improvement and accountability.
  • Organize and lead structured vendor meetings, including agendas, meeting minutes, and follow-up actions.
  • Identify, assess, escalate, and proactively mitigate vendor-related risks throughout study execution.
  • Drive cross-functional collaboration and problem-solving to ensure timely issue resolution and successful study delivery.
  • Partner closely with Functional Quality Representatives (FQRs) to ensure vendor deliverables meet quality standards and comply with study requirements.
  • Ensure vendors remain compliant with Good Clinical Practice (GCP), ICH guidelines, regulatory requirements, Biogen policies, and company procedures.
  • Facilitate effective communication and collaboration between vendors and internal study teams.
  • Maintain accurate and up-to-date vendor and study information within internal technology systems.
  • Support invoice transparency by reviewing vendor deliverables, identifying discrepancies or inconsistencies, and notifying the Clinical Trial Lead (CTL) when needed.
  • Coordinate study-level vendor performance meetings and support ongoing vendor relationship management.

What we're looking for

Required Qualifications

  • 2+ years of experience in Clinical Operations, Clinical Study Management, Vendor Management, or Clinical Operations Management within a Sponsor or CRO environment.
  • Experience managing clinical studies while balancing quality, timelines, and budget expectations.
  • Demonstrated experience managing third-party vendors and executing study-level vendor oversight activities.
  • Proven ability to establish and execute vendor management plans according to study needs.
  • Strong project management, risk assessment, contingency planning, communication, stakeholder management, and cross-functional collaboration skills.
  • Knowledge of clinical study management across one or more clinical phases (Phase I, II, or III).
  • Solid understanding and practical application of Good Clinical Practice (GCP), ICH Guidelines, and global regulatory requirements for clinical development.
  • Experience monitoring vendor performance through KPIs, governance meetings, and issue escalation processes.

Preferred Qualifications

  • Bachelor's degree or Associate's degree in a related field.
  • Previous experience overseeing third-party vendors within clinical studies.
  • Experience working with vendor oversight plans, study specifications, procurement teams, and vendor governance processes.

Why join Thermo Fisher Scientific?

  • Be part of an organization whose work directly impacts patients' lives worldwide.
  • Collaborate with global teams on innovative clinical development programs.
  • Work in an environment that values inclusion, collaboration, and continuous learning.
  • Access outstanding career development opportunities within one of the world's leading life sciences organizations.
  • Contribute to meaningful work while building a long-term career with a company committed to advancing science and improving human health.

Join us and help accelerate the future of clinical research.

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