When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $17 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Senior Clinical Regulatory Specialist/ Clinical Research Manager
This position can be located in South San Francisco, Pleasanton, or Carlsbad, California. The primary role of this position is targeted toward Clinical Studies planning, implementation, monitoring and CRO Management.
- Participate as Clinical Studies representative to project core teams
- Participate in lab assessment visits and lab selection process
- Facilitate Laboratory contacting process
- Work closely with core team and Regulatory Representative during the studies planning, coordination, and management phases.
- Document clinical studies plans/ reports for inclusion into the project Design History File (DHF)
- Interact as the primary clinical studies representative to Pharmaceutical partners concerning IVD study requirements
- Facilitate internal and external clinical studies preparation and planning meetings
- Interact as the primary interface between the company and CRO
- Ensure that CRO activities and timelines are in coordination with regulatory and project requirements
- Implement and document communication with CRO and laboratories to ensure project progress
- Real time escalation of Clinical studies issues to Project and Regulatory Management
- Update Clinical Department procedures as needed.
- Mentor/ train junior level CRA personnel.
- Candidate must be comfortable reporting to a manager located at a different facility; due to this structure, candidate must be an independent professional who proactively communicates frequently and effectively.
- Must be comfortable working on projects where the project and its team members may be located at other sites.
- Should be at ease with direct communication with internal project team members, external CROs and Pharmaceutical partners.
- Should be organized and able to work to on multiple projects with tight deadlines.
- Willing to travel away from home on an occasional basis.
- High energy level; positive attitude; works well under stress; assertive and effective communicator.
- Hands-on, action-oriented, and able to implement effectively.
- Minimum of 4 years working in the In Vitro Diagnostic (IVD) or Medical Device Industry. In Vitro diagnostic experience is a plus.
- A Minimum of 4 years demonstrated experience managing in house and/or external clinical studies.
- Experience working with multi-functional project teams is required.
- Computer literacy, including spreadsheet, database and word processing applications required.
- A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
- Working knowledge of Good Clinical Practices is required.
- Certification as a Clinical Research Professional (CCRP) is a plus
- If certification is not in place, class work/ course work in Good Clinical Practices is required.
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.