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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expert knowledge of GCP and ICH regulations, along with advanced skills in clinical trials monitoring, project management, and cross-functional teamwork. Proven ability to lead complex cardiovascular programs and drive operational excellence in clinical development.
Highest-signal resume keywords
Expert Knowledge Of GCP And ICH RegulationsClinical Trials MonitoringProject Management Professional (PMP) CertificationAdvanced Problem-Solving SkillsCross-Functional Teamwork
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 Trials MonitoringData ManagementRegulatory SubmissionsScientific WritingTherapeutic KnowledgeProgram-Wide Decision-MakingDigital And AI-Enabled ApproachesClinical Database PlatformsCentral Monitoring/RBQM PlatformsProtocol Design
Soft Skills
LeadershipCoachingMentoringCommunicationConflict Navigation
Tools & Technologies
Clinical Operations Project SchedulesTrial Plan DeliverablesPatient/Site Engagement StrategiesRisk LanguageQuality Control Tools
Certifications & Qualifications
Project Management Professional (PMP)
Industry Keywords
End-To-End Clinical Research ProcessCardiovascular ProgramsGlobal Clinical StudiesPatient SafetyEthical Standards
Tech Stack
Tools & technologiesGoogle Cloud PlatformPMP
About the role
Key responsibilities & impact- Lead and direct global, cross-functional teams in end-to-end clinical development activities from strategic planning through post-marketing approval
- Provide strategic and operational leadership for highly complex cardiovascular programs
- Lead program planning and execution, including program overviews and senior management/governance meetings
- Provide operational input on protocol design and program-level development planning documents
- Develop and maintain Clinical Operations Project Schedules and oversee trial plan deliverables
- Provide oversight of enrollment, site feasibility and selection, and patient/site engagement strategies
- Conduct resource planning and staffing, including hiring, onboarding, and management of Trial Managers and Program Leads
- Oversee program-level execution, track milestones and metrics, proactively manage delays, and escalate risks
- Drive operational feasibility, efficiency, consistency, and quality across the portfolio
- Serve as primary escalation point for trial-team operational issues and cross-functional resolutions
- Partner with PSRM on service-provider strategy, selection, qualification, contracting, and oversight
- Review regulatory submissions, Health Authority responses, meeting materials, Risk Language, and Clinical Study Reports
- Review quality and risk materials, identify operational risks, and escalate issues as needed
- Develop, maintain, and review program-level RACT and approve the Program Quality Plan
- Review protocol-level critical-to-quality factors and trial plans for consistency and quality control
- Own inspection readiness, post-inspection responses, and CAPA/SQI management
- Represent Clinical Operations on the Product Development Clinical Subteam
- Collaborate with internal and external stakeholders, including KOLs and vendors
- Lead process-improvement, digital-transformation, and strategic initiatives
- Potentially lead operational components of mergers and acquisitions
- Train, upskill, supervise, and manage the performance and professional development of direct and indirect reports
- Support CTT onboarding and develop Trial Manager training
- Drive digital proficiency and AI fluency initiatives in clinical operations
Requirements
What you’ll need- Expert knowledge of GCP and ICH regulations
- Expert understanding of the end-to-end clinical research process, therapeutic area, and competitive landscape
- Experience with scalable digital and AI-enabled approaches, including reviewing AI output and understanding limitations and constraints
- Advanced knowledge of clinical database platforms, central monitoring/RBQM platforms, and data review tools
- Advanced delegation, project-management, and program-wide decision-making skills
- Ability to navigate high-stakes conflicts with internal and external stakeholders
- Advanced problem-solving, critical-thinking, and scenario-planning skills
- Advanced verbal and written communication skills
- Strong leadership, coaching, mentoring, and talent-development skills
- Bachelor’s degree plus 15 years of pharmaceutical and/or clinical drug development experience, OR Master’s degree plus 12 years, OR PhD/PharmD plus 8 years
- Degree in life sciences preferred
- Project Management Professional (PMP) certification preferred
- Required skills include Clinical Trials Monitoring, Cross-Functional Teamwork, Data Management, Ethical Standards, Exercises Judgment, Global Clinical Studies, Patient Safety, Regulatory Submissions, Scientific Writing, and Therapeutic Knowledge
- No visa sponsorship
- 10% travel required
Benefits
Comp & perks- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- No relocation