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Project Manager
Thermo Fisher ScientificProject Manager leading central laboratory activities for Thermo Fisher Scientific’s clinical research services. Coordinating trial protocols, sponsors, vendors, compliance, and project teams.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trial activities, ensuring compliance with FDA regulations and Good Clinical Practice, while effectively coordinating with internal and external stakeholders. Proficient in project management within a Global Central Lab environment, with strong analytical and communication skills.
Highest-signal resume keywords
Clinical Trial ManagementProject ManagementRegulatory ComplianceClient Relationship ManagementProtocol Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial ProtocolsDatabase ProgrammingAnalytical SkillsOffice Productivity ApplicationsIT Systems ProgrammingStudy Specification DocumentationVersion ControlSOP ComplianceBiological-Specimen Transport RegulationsFeasibility Assessments
Soft Skills
Verbal CommunicationWritten CommunicationPresentation SkillsTime ManagementOrganizational Skills
Tools & Technologies
Project Management SoftwareEnterprise ApplicationsStandard Office Equipment
Industry Keywords
Good Clinical PracticeFDA ComplianceGlobal Central LabClinical Trial ProtocolsIATA Regulations
About the role
Key responsibilities & impact- Lead and coordinate central laboratory activities across clinical trial programs
- Monitor and manage designated clinical trial protocols in Global Central Labs
- Ensure overall project performance and client satisfaction throughout assigned trial lifecycles
- Provide oversight and coordination of study initiation
- Review, interpret, translate, and program study protocols into complete and accurate databases
- Coordinate with internal departments and external vendors to ensure project requirements are understood and followed
- Facilitate technical and clinical laboratory information flow among sites, sponsors, and non-technical stakeholders
- Prepare study specification documents and maintain the study master file with version control
- Ensure sponsor authorization and sign-off on current documents and verify contracts before service delivery
- Ensure compliance with FDA, Good Clinical Practice, SOPs, IATA, and biological-specimen transport regulations
- Coordinate protocol amendment reviews and obtain cross-functional commitment to resolve gaps and issues
- Serve as chief liaison between sponsors and internal PPD departments
- Educate investigator sites through protocol-specific laboratory procedure presentations and demonstrations
- Manage day-to-day clinical trial activities, resolve issues, and answer queries
- Consult with IT and data management teams on software and functionality for project management
- Support business development and finance teams with feasibility assessments, proposals, services, and costs
- Guide, train, and mentor Project Managers and Set-up Administrators
- Author, review, revise, and implement procedural documents
- Serve as backup for the Associate Director of Project Management when needed
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic/vocational qualification
- 2+ years of comparable experience, or equivalent combination of education, training, and experience
- Strong verbal, written, and presentation skills
- Superior time management, planning, and organizational skills
- Competence with office productivity and enterprise applications
- Ability to program IT systems according to protocol requirements
- Proven analytical skills
- Demonstrated compliance with procedures and policies
- Ability to manage multiple tasks effectively in a stressful environment
- Extensive project management knowledge and experience in a Global Central Lab environment
- Strong client relationship management skills
- Ability to work effectively with multi-level teams
- Ability to communicate and understand information with diverse groups
- Ability to use and learn standard office equipment and technology
- Ability to perform under pressure while prioritizing multiple projects
- Must be legally authorized to work in the United States without sponsorship
- Must pass a comprehensive background check, including drug screening
- May require travel
Benefits
Comp & perks- Fully remote work
- May require travel
- Professional growth and continuous development opportunities
- Accessibility accommodations during the application and interview process
- Equal employment opportunity protections