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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in TMF Operations and Inspection Readiness, with a strong focus on leadership, strategic planning, and cross-functional collaboration. Proven ability to manage teams, oversee clinical research processes, and ensure compliance with global GCP and regulatory standards.
Highest-signal resume keywords
TMF Operations ManagementInspection ReadinessLeadership ExperienceClinical Research OversightGCP Compliance Knowledge
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
TMF OperationsInspection ReadinessClinical ResearchRisk-Based OversightResource PlanningEvidence Health ManagementProcess ImprovementMetrics DevelopmentSOP DevelopmentBudget Management
Soft Skills
Team LeadershipRelationship BuildingChange ManagementClear CommunicationPerformance Management
Certifications & Qualifications
PhDPharmDMScBScRN
Industry Keywords
Life SciencesBiopharmaceuticalsClinical TrialsCRORegulatory Expectations
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead the Study Evidence and Readiness function, encompassing TMF Operations and Inspection Readiness
- Set the strategy and priorities for TMF Operations and Inspection Readiness
- Lead and develop global teams, including line management of Inspection Readiness Senior Managers and Managers
- Set goals, manage performance and engagement, and build succession and capability plans
- Provide integrated oversight of TMF health, critical evidence, inspection readiness, and material evidence gaps across the study portfolio
- Establish metrics, thresholds, and escalation recommendations
- Plan and manage departmental structure, capacity, resources, budget, suppliers, training, and business continuity
- Lead improvement initiatives strengthening evidence quality, completeness, retrievability, and readiness
- Represent the function in process improvement, standards development, and integration work
- Develop and maintain TMF and inspection-readiness processes, policies, SOPs, work instructions, and related materials
- Partner cross-functionally to resolve evidence issues, interpret trends, apply root-cause insights, and drive sustainable improvement
- Provide leadership reporting on evidence health, readiness risks, remediation progress, and portfolio trends
- Contribute to leadership forums and governance committees
- Support audits and inspections, including preparation, response support, and lessons learned
- Build relationships with internal and external experts
Requirements
What you’ll need- Doctorate degree & 4 years of directly related experience or equivalent OR Master’s degree & 8 years of directly related experience or equivalent OR Bachelor’s degree & 10 years of directly related experience or equivalent
- 4 years of direct managerial and/or leadership experience or equivalent
- PhD, PharmD, MSc, BSc, or RN qualification preferred
- 11 years of work experience in life sciences or a medically related field, including 8 years in biopharmaceutical clinical research at a biotechnology company, pharmaceutical company, or CRO preferred
- Leadership experience managing direct reports, including management-level staff
- Experience in TMF operations and inspection readiness, preparation, inspection support, or response
- Experience managing or overseeing external clinical research vendors
- Knowledge of global GCP and regulatory expectations for clinical trial conduct, TMF records, and inspection readiness
- Knowledge of risk-based oversight, evidence health, resource planning, and organizational capacity
- Experience leading cross-functional work in a matrix organization, including projects, budgets, timelines, and quality metrics
- Ability to build relationships, lead change, develop high-performing teams, and communicate clearly
- Sponsorship for this role is not guaranteed
Benefits
Comp & perks- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible
- Career development opportunities
- Work/life balance
- Financial plans with opportunities to save towards retirement or other goals