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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in leading global clinical trial start-up activities, with a strong focus on ICH-GCP guidelines and regulatory compliance. Proven ability to manage cross-functional teams and drive operational excellence through data-driven decision-making and process improvements.
Highest-signal resume keywords
Global Clinical Trial Start-UpICH-GCP GuidelinesProject ManagementCross-Functional Team LeadershipVendor Management
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 RegulationsSite Activation StrategiesRisk ManagementData AnalysisPerformance MetricsRegulatory Document SubmissionOperational Decision-MakingProcess ImprovementForecastingSite Initiation Readiness
Soft Skills
CommunicationNegotiationLeadershipMentoringProblem-Solving
Industry Keywords
PharmaceuticalBiotechnologyClinical ResearchCRO ManagementGlobal Study Start-UpHigh-Profile Clinical DevelopmentStaff DevelopmentPerformance ManagementOperational ExcellenceCountry-Specific Regulatory Requirements
About the role
Key responsibilities & impact- Develop and execute global site and country start-up strategies for complex clinical trials
- Identify risks, dependencies, and mitigation plans
- Lead site activation planning and forecasting activities to ensure study milestones and timelines are achieved
- Partner with Clinical Operations, Regulatory Affairs, CROs, and other stakeholders to drive efficient study start-up execution
- Monitor and evaluate start-up metrics, leveraging data and trends to improve performance and inform strategic decision-making
- Oversee regulatory document collection, submissions, site initiation readiness, and milestone tracking
- Provide leadership and direction to CRO partners and internal teams to ensure high-quality and compliant start-up delivery
- Serve as the primary escalation point for site start-up challenges, proactively resolving issues and driving cross-functional alignment
- Manage and develop a team of Site Start-Up professionals through coaching, performance management, mentoring, and career development initiatives
Requirements
What you’ll need- Bachelor's degree and 8+ years of pharmaceutical, biotechnology, or clinical research industry experience
- Extensive experience leading global clinical trial start-up activities, including country and site activation strategies
- Strong knowledge of ICH-GCP guidelines, clinical trial regulations, and global study start-up processes
- Demonstrated ability to lead cross-functional teams and influence stakeholders across a global organization
- Proven experience managing vendors and CROs, including performance oversight and issue resolution
- Excellent project management, communication, negotiation, and risk management skills
- Previous direct line management experience with responsibility for staff development and performance management
- Experience supporting complex, high-profile, and global clinical development programs
- Strong analytical mindset with a data-driven approach to forecasting, metrics review, and operational decision-making
- Experience driving process improvements and operational excellence initiatives within Clinical Development
- Advanced understanding of country-specific regulatory and site activation requirements across multiple regions
- Ability to work primarily in a computer-based environment
- Ability to travel domestically and internationally up to 25% as required
- Ability to participate in meetings across multiple global time zones
Benefits
Comp & perks- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical, dental, vision, life, and disability insurance benefits
- Paid time off
- Family support benefits
- Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses