Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific Inc., we are driven by our mission to enable our customers to make the world healthier, cleaner, and safer. With 80,000 colleagues across the globe, we strive to bring our mission to life each day and go beyond the ordinary to develop outstanding solutions for some of the toughest challenges in science.

Job Title: Clinical Affairs Manager

Job Responsibilities:

• Participate as a Clinical Affairs representative to project core teams.

• Work closely with core team and Regulatory Representative during the study planning, coordination, execution, and management phases.

• Develop clinical study plans/reports for inclusion into the project Design History File (DHF).

• Lead all aspects of clinical study execution on assigned projects, including site qualifications, selections, visits, study monitoring, and eTMF completion.

• Facilitate internal and external clinical studies preparation and planning meetings.

• Interact as the primary interface between the company, CRO, and study sites.

• Ensure that CRO activities and timelines are in coordination with regulatory and project requirements.

• Coordinate and connect with cross-functional team on projects to ensure project progress.

• Promptly advise the Clinical Affairs Director and project core teams of any clinical study issues as they arise.

• Update Clinical Affairs procedures to ensure alignment with global regulations and guidelines.

• Manage and lead clinical projects and initiatives.

• Cross functional training on clinical affairs activities and processes.

Job Requirements:

• Bachelor's degree in Biology, Chemistry, bio-engineering or related science, or equivalent experience

• Confirmed understanding of Good Clinical Practices and international clinical study regulation is required (e.g. IVDR)

• Clinical Research Professional Certificate (CCRP) or equivalent is a plus

• If certification is not in place, class work/course work in Good Clinical Practices is required

• Minimum of 5 years working in the In Vitro Diagnostic (IVDs) or Medical Device Industry

• Minimum of 5 years proven experience managing in-house and/or external clinical studies

• Experience working with multi-functional project teams is required.

• Digital literacy is required: proficiency with Microsoft Office suite, eDC, eTMF tools.

Key Skills and Abilities:

• Outstanding ability to communicate frequently and effectively.

• Comfortable working on projects with team members located at other sites.

• Skilled in direct communication with internal project team members and external CROs

• Organized and willing to work on multiple projects with tight deadlines

• Comfortable with ambiguity and change

• Ability to remain flexible and adaptable in a wide range of scenarios.

• Engaged, practical, and skilled in implementing strategies effectively

• Emphasizing continuous improvement while prioritizing quality and efficiency

• Able to work autonomously in a matrix-managed organization

• Ability to provide solutions based on knowledge of clinical research and industry experience.

Thermo Fisher Scientific is an equal opportunity employer providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation during the application process, please contact us at 1-855-471-2255*. We will ensure that you have the support to successfully complete your application.

Compensation and Benefits

The salary range estimated for this position based in Maryland is $113,500.00–$170,200.00.

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: https://jobs.thermofisher.com/global/en/total-rewards

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.