Senior Bioanalytical Study Manager

Thermo Fisher Scientific

. Lead and maintain direct oversight of a portfolio of client projects .

Posted 10/12/2026full-timeRemote • North Carolina • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge in Project Management, ensuring compliance with FDA regulations and Good Clinical Practice while effectively managing client relationships and project performance. Capable of coordinating multi-level teams and facilitating communication between stakeholders in a clinical environment.

Highest-signal resume keywords

Project ManagementClient Relationship ManagementRegulatory ComplianceNegotiation SkillsAnalytical Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project ManagementBudget ManagementContract PreparationCompliance with FDA RegulationsGood Clinical PracticeLaboratory Environment ExperienceVersion ControlInvoicingRFP Feasibility AssessmentData Management Consultation

Soft Skills

Strong Verbal CommunicationStrong Written CommunicationPresentation SkillsTime ManagementOrganizational Skills

Certifications & Qualifications

Bachelor's Degree or Equivalent

Industry Keywords

Clinical LaboratoryBiological Specimen Transport RegulationsExposure Control PlansPPD SOPsMulti-Level Team Collaboration

About the role

Key responsibilities & impact

Lead and maintain direct oversight of a portfolio of client projects
Manage overall project and portfolio performance, including resources, budgets, and prioritization
Serve as the primary operational interface and chief liaison between PPD and the client
Negotiate and make real-time decisions with clients
Provide oversight and coordination to internal departments and external clients
Facilitate technical and clinical laboratory information flow among stakeholders
Prepare and maintain project specifications, budgets, contracts, and version-controlled master files
Ensure sponsor authorization and compliance before services are delivered
Ensure compliance with FDA, Good Clinical Practice, PPD SOPs, personnel policies, exposure control plans, and biological specimen transport regulations
Coordinate internal groups and support staff to resolve procedural, budgetary, and documentation issues
Manage day-to-day project activities, resolve issues, and answer queries
Consult with IT and data management groups on software and functionality for project management
Support RFP feasibility assessments and draft proposal responses with BD and finance teams
Take responsibility for accurate invoicing and coordinate billing for the client's portfolio

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
5+ years of previous relevant experience, or equivalent combination of education, training, and experience
Strong science and/or business acumen
Strong verbal, written, and presentation skills
Superior time management, planning, and organizational skills
Proven analytical skills
Demonstrated compliance with procedures and policies
Ability to perform multiple tasks effectively in a stressful environment
Extensive knowledge and experience in Project Management
Strong client relationship management skills
Ability to work effectively with multi-level teams
Ability to work in a fast-paced undefined environment
Strong negotiation skills
Ability to work in a laboratory and/or clinical environment
Ability to undertake occasional drives to site locations and occasional domestic travel
Ability to work with potential exposure to biological fluids and infectious organisms
Ability to use required personal protective equipment such as protective eyewear, garments, and gloves

Benefits

Comp & perks

Healthy and balanced work environment
Collaboration and development opportunities
Personal protective equipment provided/required for the role