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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical project management, including oversight of clinical trials, budget management, and risk assessment. Proficient in leading high-performing teams and ensuring compliance with regulatory standards while driving project performance and client satisfaction.
Highest-signal resume keywords
Clinical Project ManagementICH Guidelines and GCP KnowledgeFinancial Tracking SystemsTeam Leadership and MentoringPhase I/FIH Experience
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 ManagementRisk ManagementProject Scope ManagementBudget ManagementData AnalysisRegulatory SubmissionsSubject Recruitment StrategiesKPI TrackingChange Order ProcessClinical Resource Projections
Soft Skills
Excellent CommunicationOrganizational SkillsTeamwork and CollaborationProblem SolvingNegotiation Skills
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft ProjectMicrosoft AccessMicrosoft PowerPoint
Certifications & Qualifications
PMP CertificationRelevant Allied Health Certification
Industry Keywords
Clinical ResearchClinical TrialsMatrix EnvironmentOperational ExcellenceBid Defense Preparation
Tech Stack
Tools & technologiesGoogle Cloud PlatformPMP
About the role
Key responsibilities & impact- Provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards
- Own clinical delivery of clinical research trials and function as the Clinical Project Manager within the core project team
- Partner with the Project Manager and functional leads to ensure successful delivery of clinical trial activities within contractual and budgetary requirements
- Oversee clinical and site management aspects of trials and represent clinical delivery with customers
- Drive clinical project performance toward contracted deliverables while meeting customer needs and maintaining operational excellence
- Drive communication and collaboration with clients and project teams in a matrixed, multicultural environment
- Lead clinical project strategy development and prioritization, including management of project scope, timelines, quality and budget
- Prepare and deliver presentations for new business as required
- Manage project operations supporting subject recruitment and retention, clinical vendor delivery and monitoring visit strategy
- Identify clinical project, financial and quality risks using end-to-end risk management and quality-by-design principles
- Use data sources, dashboards and risk management strategies to drive innovation and proactive problem solving
- Maintain project governance and issue escalation pathways, including clinical project plans addressing identified risks
- Oversee clinical project budgets, resources and scope; ensure budget and financial milestone adherence
- Forecast clinical project revenue and manage project costs within budget
- Lead scope changes and the change order process; track KPIs for client-specific metrics
- Provide leadership for high-performing clinical project teams and facilitate communication, teamwork and delivery
- Ensure accurate clinical resource projections and escalate resource constraints
- Develop and mentor team members and provide feedback to line managers
- Participate in and oversee regulatory/ethics committee submissions, tracking and documentation
- Support new business through Bid Defense preparation and meetings
- Perform other duties as needed or assigned
Requirements
What you’ll need- University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- Fluent in English, both written and verbal
- 2+ years of Clinical Team Lead experience or an equivalent combination of education and experience to successfully perform key responsibilities of the job
- Phase I/FIH experience
- Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Advanced computer skills (e.g., Microsoft Word, Excel, Project, Access and Power Point)
- Experience managing projects in a matrix and virtual environment
- Excellent communication, planning and organizational skills
- Demonstrated ability to lead by example and to encourage team members to seek solutions independently
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
- Financial awareness and ability to actively and effectively utilize financial tracking systems
- Ability to work independently and mentor junior project team members
- Ability to negotiate and liaise with clients in a professional manner
- Ability to present to staff at all levels
- Preferred: Master or other advanced degree
- Preferred: PMP certification
- Preferred: 2+ years CRA experience, on-site or in-house
Benefits
Comp & perks- Equal Employment Opportunity and accommodations support
- Remote/homebased work arrangement
