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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing clinical trial operations, including study start-up, execution, and close-out, while ensuring compliance with GCP and ICH guidelines. Proficient in vendor management, budget oversight, and cross-functional collaboration to drive successful study outcomes.
Highest-signal resume keywords
Clinical Trial ManagementVendor OversightGCP KnowledgeProject CoordinationRegulatory Submissions
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 OperationsStudy Start-UpSite ActivationMonitoring OversightBudget ManagementClinical Document ReviewData MonitoringClinical Sample LogisticsEarly-Phase Clinical StudiesRegulatory Compliance
Soft Skills
Clear CommunicationProblem SolvingRelationship BuildingOrganizational SkillsCollaboration
Tools & Technologies
SmartsheetMicrosoft OfficeProject Tracking Tools
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryCRO ManagementClinical Research RegulationsMRNA TherapeuticsGene TherapyCNS ExperienceRare Disease Studies
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead day-to-day clinical trial operations across assigned studies, sites, CROs, laboratories, and vendors
- Manage study start-up, site activation, monitoring oversight, and close-out activities
- Own and manage study timelines, budgets, invoices, vendor deliverables, and key milestones
- Oversee study documentation and trial master file quality to support inspection readiness
- Review and provide operational leadership on clinical documents, including protocols, ICFs, CRFs, SAPs, CSRs, study plans, and related materials
- Partner with cross-functional study teams to drive study execution, resolve operational issues, and support study milestones
- Manage clinical sample logistics between patients, sites, and laboratory vendors
- Drive timelines and logistics for Safety Review Boards, Data Monitoring Committees, data cuts, and related study activities
- Lead or support vendor review, selection, contracting, onboarding, and performance oversight
- Build and manage relationships with investigative sites, CROs, vendors, clinical experts, and internal stakeholders, including planning investigator meetings
- Identify, escalate, and resolve study risks and operational issues
- Represent the company externally with study partners and investigative sites
- Travel domestically and internationally to investigative sites or study-related meetings as needed
Requirements
What you’ll need- Bachelor’s degree in a scientific, health-related, or related field
- 6+ years of progressive clinical operations experience in the pharmaceutical and/or biotechnology industry
- Experience managing clinical trial execution from start-up through close-out
- Experience managing early-phase clinical studies; rare disease or CNS experience preferred
- Experience managing U.S. and global clinical trials across CROs, vendors, laboratories, and study sites
- Familiarity with ethics committee and regulatory submissions, such as pre-IND, IND, Scientific Advice, CTA, or similar filings
- Strong knowledge of GCP, ICH guidelines, clinical research regulations, and the drug development process
- Experience with vendor oversight, budgets, contracts, invoices, and change orders
- Strong clinical operations leadership, project coordination, planning, and organizational skills
- Proficiency with Smartsheet, Microsoft Office, or similar project and study tracking tools
- Clear communication skills and ability to work effectively with internal and external stakeholders
- Knowledge of mRNA, RNAi, gene therapy, or gene-editing therapeutics; familiarity with LNP or AAV-based development preferred
- Ability to work independently and collaboratively in a fast-paced environment
- Hands-on mindset and willingness to work across multiple areas of clinical operations in a startup environment
Benefits
Comp & perks- Bonus eligibility
- New hire equity
- Comprehensive health coverage
- Discretionary paid time off
- Fully remote role