FSP-Senior Bioanalytical Study Manager

Regulatory Jobs; North Carolina; On-site; USD 100,000 - 150,000; Full time

Job summary

Thermo Fisher Scientific seeks a Senior Project Manager to lead bioanalytical operations for pre-clinical studies and clinical trials, ensuring timely delivery of quality data. You will coordinate with multi-disciplinary teams to drive study execution, data integrity, and process improvements across LC-MS workflows and analytical platforms.

You will oversee vendor contracts, document development, sample logistics, and data transfer specifications, working in a collaborative, fast-paced

Qualifications

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• 5+ years of experience or equivalent combination of education, training, & experience in bioanalytical/project management.

Responsibilities

• Vendor management: lead contracting with third-party lab service providers for assay development and validation.
• Study coordination: manage critical reagent supply and sample analysis with cross-functional teams to meet timelines.
• Documentation & Data: contribute to clinical trial documents (eCRFs, ICFs, SOWs) and data transfer specifications, ensure data accuracy.
• Sample logistics: track testing, reconcile results, and support data cleaning and finalization.

Skills

Vendor management

Cross-functional collaboration

Data analysis

Excel proficiency

Education

Bachelor's degree or equivalent

Tools

SOPs

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

The Senior Project Manager -Join our dynamic team and lead the charge in supporting our development 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 (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.

Education and Experience Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.

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.
• Demonstrated experience supporting and managing both small- and large-molecule studies, including LC-MS workflows, with the flexibility to work across multiple analytical platforms and study types. Able to handle multiple demanding programs at one time.

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.

Working Environment

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Why join us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.