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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Senior Bioanalytical Study Manager

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. At PPD, part of Thermo Fisher Scientific, we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk; our award-winning training programs speak for themselves.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Role Overview:

Join our dynamic team and lead the charge in supporting our client’s pipeline from a bioanalytical perspective. You'll manage bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data by coordinating activities between multiple stakeholders.

Key Responsibilities:

+ Vendor Management: Lead the contracting with third-party lab service providers for assay development and validation. Collaborate with business operations, procurement, and clinical teams to ensure appropriate SOWs and contracts.

+ Study Coordination: Manage critical reagent supply and sample analysis. Work closely with bioanalytical strategy leads, clinical trial teams, and lab service providers to finalize study documents and meet timelines. Support the development of novel Bioanalytical processes.

+ Documentation & Data: Provide input into clinical trial documents (e.g., eCRFs, ICFs, SOWs). Drive the delivery of data transfer specifications and ensure data accuracy.

+ Sample Logistics: Track and reconcile sample testing, resolving any issues that arise. Contribute to cleaning and finalizing data.

Qualifications:

Education: BA/BS or higher in medical science or a related field, plus 5+ years (BA/BS) or 2+ years (MS) of clinical trial management experience.

_In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._

Experience:

+ Familiarity with clinical bioanalysis outsourcing operations.

+ Knowledge of GLP, GCP guidelines, and vendor audits.

+ Understanding of clinical trial design and data outputs.

+ Experience with sample collection instructions and lab manuals.

+ Proficiency in data transfer agreements/specifications and data reconciliation.

Skills:

+ Strong organizational and analytical skills.

+ Excellent written/verbal communication.

+ Ability to work both independently and as part of a team.

+ Proficiency with Excel and other interactive programs.

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 Maryland is $63,000.00–$107,000.00.

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.