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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in GCP compliance, inspection readiness, and clinical trial operations, with a strong focus on regulatory adherence and quality management. Proven ability to lead cross-functional teams and drive accountability in a fast-paced clinical development environment.
Highest-signal resume keywords
GCP ComplianceClinical Trial OperationsRegulatory Inspection ReadinessSOP DevelopmentCRO Oversight
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 ExecutionRisk-Based Inspection Readiness FrameworkData Integrity ManagementTMF RequirementsRegulatory ComplianceOperational Process ImprovementClinicalTrials.gov RegistrationMock InspectionsGap AssessmentsQuality Management Systems
Soft Skills
Cross-Functional LeadershipExcellent Communication SkillsAnalytical ThinkingProblem-SolvingProject Management
Industry Keywords
ICH-GCPClinical DevelopmentBiotechnologyPharmaceuticalQuality Systems
About the role
Key responsibilities & impact- Provide Sponsor-level leadership for inspection readiness and GCP compliance across clinical studies, programs, and functional areas
- Develop, implement, and maintain a risk-based inspection readiness framework
- Assess clinical study and operational-process readiness, including documentation, Sponsor oversight, issue management, data integrity, and regulatory adherence
- Identify compliance, process, documentation, and oversight gaps and drive remediation and preventive actions
- Oversee clinical trial registration and results-reporting requirements, including ClinicalTrials.gov
- Track reporting requirements, accountabilities, timelines, supporting documentation, and compliance evidence
- Assess clinical development training requirements and training matrices
- Review and improve SOPs, work instructions, plans, templates, and controlled documents
- Support development, implementation, training, and adoption of new or revised processes
- Partner with Data Management/Biometrics and cross-functional teams on operational quality, data integrity, issue resolution, and database-lock readiness
- Support inspection-ready Trial Master Files and essential records
- Evaluate CRO and vendor oversight practices and documentation
- Establish inspection-readiness metrics, dashboards, risk indicators, and management routines
- Lead or coordinate mock inspections, gap assessments, and targeted deep dives
- Support regulatory inspections and Sponsor audits, including planning, document readiness, interview preparation, response coordination, and remediation
- Partner with Quality to align Clinical Operations execution with the Quality Management System
- Monitor evolving ICH-GCP expectations, regulations, inspection trends, and industry best practices
- Promote quality, accountability, operational discipline, continuous improvement, and proactive inspection readiness
- Provide senior-level coaching and guidance on GCP compliance, inspection readiness, documentation, and operational excellence
- Support strategic initiatives across Global Clinical Operations and the broader development organization
- Travel domestically and internationally up to 20–30% as required
Requirements
What you’ll need- Bachelor’s degree in life sciences or a related field
- 15+ years of clinical operations, clinical quality, or related drug-development experience
- Substantial direct experience in global clinical trial execution and inspection readiness
- Deep knowledge of ICH-GCP, Sponsor responsibilities, applicable clinical trial regulations, quality systems, and regulatory inspection expectations
- Experience preparing for and supporting regulatory inspections, Sponsor audits, mock inspections, and inspection-readiness assessments
- Strong understanding of end-to-end clinical trial operations across study start-up, conduct, monitoring, data management, safety interfaces, TMF, CRO/vendor oversight, database lock, closeout, and reporting
- Experience with clinical trial registration and results disclosure requirements, including ClinicalTrials.gov
- Experience reviewing, developing, or improving SOPs, work instructions, controlled documents, training requirements, and operational processes
- Experience assessing and remediating cross-functional compliance and operational gaps
- Strong knowledge of TMF requirements and inspection-ready documentation practices
- Experience partnering with Data Management/Biometrics, Regulatory, Quality, Clinical Development, Safety, and other functions
- Strong CRO and vendor oversight experience
- Ability to operate effectively in a small, fast-paced, growth-oriented biotechnology or pharmaceutical environment
- Strong cross-functional leadership and ability to influence senior stakeholders and drive accountability without direct authority
- Excellent written and verbal communication skills, executive presence, sound judgment, and ability to communicate complex compliance and operational issues clearly and pragmatically
- Highly analytical, detail- and process-oriented, with strong project management, problem-solving, prioritization, and follow-through
- Legal authorization to work in the United States
Benefits
Comp & perks- Medical insurance
- Dental insurance
- Paid time off
- 401(k) with a generous company match
- Equity
- Bonus