Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Within the Regulatory and Clinical Affairs division, we focus on ensuring that both internal and external projects for advancing our in vitro diagnostics adhere to Good Clinical Practice (GCP) and relevant regulatory standards (national and international). We also ensure that FDA submissions are complete, accurate, and timely to secure approvals that support the business units. .

Discover Impactful work

Your work will improve the quality of FDA submissions and assist in acquiring the necessary approvals for our products to be marketed, ultimately benefiting the patients who need these diagnostics.

What will you do?             

The main responsibility of this position is to support clinical studies and manage study sites. In this role, you will:

Coordinate and conduct activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics

Ensure studies are conducted and documented in accordance with the study protocol, SOPs, GCP and other applicable regulatory requirements.

Collect all clinical study essential documents.

Participate in lab assessment visits.

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

Implement and document communication with CRO and laboratories to ensure project progress.

Timely resolution of partner concerns in Clinical studies to Clinical Study Managers.

How will you get here?

Education

Bachelors degree in Biology, Chemistry, bio-engineering or related science.

Experience

3+ years experience in the In Vitro Diagnostic, Medical Device Industry or similar.

3+ years of demonstrated experience leading in house and/or external clinical studies.

CDx/IVD clinical experience desired.

Veeva Vault/eTMF, Medrio/EDC experience desired.

Knowledge, Skills and Abilities

Working knowledge of Good Clinical Practices.

CCRP certification or coursework in Good Clinical Practices.

Experience with multi-functional project teams.

Computer literacy in spreadsheets, databases, and word processing applications.

Proactive communicator, high energy, positive attitude, and ability to work well under stress.

Comfortable with remote project teams.

Direct communication with internal teams and external CROs.

Organized, able to manage multiple projects with tight deadlines.

Occasional travel required.

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 $91,700.00–$137,525.00.

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