Clinical Affairs Manager, in vitro diagnostics
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Job Location:
South San Francisco, CA - USA
Monthly Salary:
$ 112500 - 130000
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
This position is part of the Regulatory and Clinical Affairs organization which ensures that the internal and external work performed to develop our in vitro diagnostics is in compliance with Good Clinical Practice applicable regulatory requirements (domestically and internationally) and is submitted to the FDA in a complete accurate and timely manner for approvals in support of the business units.
Discover Impactful Work:
Your work will impact the quality of the FDA submissions and help secure the necessary approvals for our products to be marketed and reach the patients who will ultimately benefit from these companion diagnostics.
A Day in the Life:
The primary role of this position is targeted toward Clinical Studies planning core team support and CRO this role the primary responsibilities include:
- Participate as a clinical study representative for project core teams.
- Participate in lab assessment visits and lab selection process.
- Work closely with the core team and regulatory representative during the studies planning coordination and management phases.
- Document clinical studies plans/ reports for inclusion into the Design History File (DHF) project.
- 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 to ensure that CRO activities and timelines are in coordination with regulatory and project requirements.
- Real time elevation of Clinical studies issues to Project and Regulatory Management.
- Mentor/ train junior-level personnel.
Keys to Success:
Education and Experience
- A . degree in biology chemistry bio-engineering or related science is required.
- Solid understanding of Good Clinical Practices is required.
- 4 years working in the In Vitro Diagnostic or Medical Device Industry; companion Diagnostic experience is a plus.
- 4 years of demonstrated experience managing in-house and/or external clinical studies preferred.
- 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 strongly preferred.
- Experience working with multi-functional project teams is required.
- Digital literacy including spreadsheet database and word processing applications required.
Knowledge Skills Abilities
- Ability to work 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.
- Willing to travel away from home on an occasional basis.
- High energy level; positive attitude; works well under stress; assertive and effective communicator.
Benefits:
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Compensation and Benefits
The salary range estimated for this position based in California is $112500.00$130000.00.This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:
A choice of national medical and dental plans and a national vision plan including health incentive programs
Employee assistance and family support programs including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy
Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan
Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits please visit: Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
