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Labs Project Manager
Thermo Fisher Scientific. Lead and coordinate central laboratory activities across clinical trial programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive knowledge and experience in Project Management within a Global Central Lab environment, ensuring compliance with FDA regulations and Good Clinical Practice. Capable of effectively coordinating clinical trial activities, managing client relationships, and facilitating communication among diverse teams.
Highest-signal resume keywords
Project ManagementClinical Trial CoordinationRegulatory ComplianceClient Relationship ManagementAnalytical Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Protocol ManagementDatabase ManagementIT System ProgrammingStudy Specification PreparationWorkflow Efficiency Identification
Soft Skills
Strong Verbal CommunicationPresentation SkillsTime ManagementOrganizational SkillsAbility to Work Under Pressure
Tools & Technologies
Office Productivity ToolsProject-Management SoftwareEnterprise Applications
Industry Keywords
Good Clinical PracticeFDA ComplianceBiological-Specimen Transport RegulationsIATA RegulationsPPD SOPs
About the role
Key responsibilities & impact- Lead and coordinate central laboratory activities across clinical trial programs
- Monitor and manage all aspects of designated clinical trial protocols in Global Central Labs
- Oversee study initiation and translate 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 investigational sites, sponsors, and non-technical personnel
- Prepare study specification documents and maintain study master files with version controls for specifications, budgets, and contracts
- Ensure sponsor authorization and sign-off on current documents and verify contracts before service delivery
- Ensure compliance with FDA, Good Clinical Practice, PPD SOPs, personnel policies, exposure-control requirements, IATA, and biological-specimen transport regulations
- Coordinate protocol reviews, amendments, budgets, and issue resolution across internal groups
- Serve as chief liaison between sponsors and PPD internal departments throughout study phases
- 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 design, validation, and implementation of project-management software and functionality
- Support RFP feasibility assessments and draft proposal responses with business development and finance teams
- Guide, train, and mentor Project Managers and Set-up Administrators
- Identify workflow efficiencies and author, review, revise, and implement procedural documents
- Serve as backup for the Associate Director PM when needed
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- 2+ years of previous experience, or equivalent combination of education, training, and experience
- Strong verbal, written, and presentation skills
- Superior time management, planning, and organizational skills
- Competence with computers and enterprise applications, including office productivity tools
- Ability to program the IT system according to protocol requirements
- 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 in a Global Central Lab environment
- Strong client relationship management skills
- Ability to work effectively with multi-level teams
- Must be legally authorized to work in the United States without sponsorship
- Must be able to pass a comprehensive background check, including drug screening
- Ability to communicate, receive, and understand information and ideas with diverse groups
- Ability to work upright and stationary for typical working hours
- Ability to use and learn standard office equipment and technology proficiently
- Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities
- May require travel
Benefits
Comp & perks- Global organization committed to employee health and wellbeing
- Healthy and balanced work environment
- Continuous development and growth opportunities
- Accessibility services and accommodations for job seekers with disabilities