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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical operations with a focus on managing complex FDA-facing trials, particularly in neurology. Proven ability to lead clinical delivery, ensure quality standards, and mentor teams while navigating regulatory requirements.
Highest-signal resume keywords
Clinical Operations ManagementFDA Regulatory ExperiencePhase 2 Drug TrialsSOP and Process DesignClinical Trial Systems (EDC, CTMS, eTMF)
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 ManagementQuality OversightRisk MitigationTrial Design Sign-offMonitoring Plan DevelopmentProtocol Deviation ManagementETMF ReadinessClinical Development PlanningRegulatory ComplianceTrial Documentation
Soft Skills
LeadershipMentoringCollaborationProblem-SolvingProactive Communication
Tools & Technologies
CitrusEDCCTMSETMF
Industry Keywords
Neurology TrialsChronic IndicationsClinical DeliveryHealthcare OperationsVC-Funded Startup
About the role
Key responsibilities & impact- Take personal ownership of clinical delivery for one in-licensed asset, running the trial from start-up through close-out
- Own the trial’s clinical and regulatory execution, quality, and on-time, on-budget delivery
- Work closely with and line-manage the Clinical Program Manager running the trial day-to-day
- Proactively identify and mitigate risks by contributing to the asset’s clinical development plan
- Collaborate with Programme Directors in the Corporate Development team
- Build clinical operations and regulatory capability for more complex, FDA-facing trials
- Raise monitoring, oversight, and quality standards across the Clinical Operations team
- Contribute to ClinOps SOP and process design across the portfolio with the Director of Quality
- Partner with technology and product teams on Citrus and other clinical delivery tools and systems
- Guide, mentor, and support professional development of the wider ClinOps team
- Serve as senior authority for operational and quality decisions and sign-off across every trial in the portfolio
- Provide sign-off on safety, trial design, proportionality, essential trial documentation, and quality issues
- Collaborate with cross-functional leads to resolve issues
- Report to the VP Operations
Requirements
What you’ll need- 15+ years in clinical operations, with genuine hands-on delivery across multiple Phase 2 drug trials
- Experience with complex neurology trials in chronic indications, ideally in Parkinson’s disease
- Real, first-hand experience making clinical, quality and safety judgement calls in real time across a range of trials
- Track record of senior review and sign-off on essential trial documents, including monitoring plans, RAMPs, protocol deviations, and eTMF readiness
- Proportionate, risk-based approach to clinical oversight
- Track record of contributing to or leading SOP and process design at a portfolio or function level
- Broad experience across trial types, phases and therapeutic areas
- Comfortable shaping clinical trial systems including EDC, CTMS, and eTMF
- Experience across multiple regulatory jurisdictions is a strong plus, with FDA preferred
- High agency and bias for action
- Passion and curiosity about changing healthcare operations and health-treatment development
- Interest in working at a high-growth, mission-driven, VC-funded startup
Benefits
Comp & perks- Competitive salary, plus meaningful stock options
- 27 days annual leave in addition to 11 National Holidays
- Health insurance coverage through our PEO Trinet
- $40 monthly wellness allowance, which you can spend on a wellhub membership, or wellness activities and expenses of your choice!
- Enhanced Parental Leave: 16 weeks full pay for primary caregiver and 6 weeks full pay for secondary caregiver
- $2,000 Learning and Development allowance each year to put towards courses, certifications, and development
- Regular whole company and team events, both in person and virtually
- Access to gym and retail discounts through our benefits platform Happl
- Monthly lunch voucher for our remote teams
- Charity events and fundraising opportunities through our charity partnership with the Forward Trust