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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, including FDA pivotal trials and European MDR investigations, with a strong focus on operational execution, compliance, and stakeholder management. Proficient in overseeing budgets, timelines, and regulatory requirements while ensuring data integrity and patient safety.
Highest-signal resume keywords
Clinical Trial ManagementFDA Regulatory ComplianceIRB Submission LifecycleEDC and eTMF SystemsStakeholder Management
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 ResearchFDA RegulationsISO 14155SaMD Clinical TrialsData ManagementProtocol AdherenceBudget ManagementRisk ManagementMonitoring StrategyProblem-Solving
Soft Skills
Structured Problem-SolvingClear PrioritizationCommitment to Patient SafetyStakeholder EngagementCollaboration
Industry Keywords
21 CFR Parts 81221 CFR Parts 5021 CFR Parts 5621 CFR Part 11ICH-GCPMDRBIMOSOPsCIPICF
About the role
Key responsibilities & impact- Own operational execution of the US clinical program, including the FDA pivotal trial and randomized pragmatic trial
- Oversee European MDR investigations run out of Berlin
- Lead trial start-up, including site selection, agreements, budgets, IRB submissions, site initiation and training
- Drive enrollment and protocol adherence across sites with investigators and site coordinators
- Own the monitoring strategy and conduct remote and on-site monitoring visits
- Manage contract monitors
- Own study budgets, timelines and risk registers, reporting to the Chief Medical Officer
- Run the operational backbone, including eTMF, EDC, data cleaning and protocol deviations
- Ensure FDA BIMO and IRB audit and inspection readiness
- Maintain sponsor SOPs
- Support European investigations and regulatory compliance under ISO 14155 and MDR
- Author and maintain SOPs and work instructions for clinical operations, monitoring and data management
- Coordinate academic partners and specialist vendors
- Collaborate with the CMedO, Clinical Research Lead, regulatory, product and R&D teams
- Help grow the clinical team
Requirements
What you’ll need- Degree in life sciences, nursing, medicine, biomedical engineering or a related field
- 5+ years in clinical research, including 3+ years in US FDA-regulated devices
- Familiarity with SaMD clinical trials
- Hands-on experience with the full IRB submission lifecycle, including preparing and submitting packages and amending documents such as the CIP and ICF
- Hands-on experience taking a US multicenter trial from start-up through enrollment and closing, on the sponsor side and without a full-service CRO
- Working knowledge of 21 CFR Parts 812, 50, 56 and 11, ICH-GCP, ISO 14155 and HIPAA
- Practical experience with EDC and eTMF systems
- Structured problem-solving and clear prioritization under shifting timelines
- Strong stakeholder management across academic sites, health systems and senior KOLs
- Uncompromising commitment to patient safety, data integrity and inspection readiness
- Fluency in English
- Authorized to work in the US
Benefits
Comp & perks- Meaningful equity
- Fully remote setup in the US
- Up to 30% travel in the first 12 months, less thereafter
- Occasional trips to the Berlin office
- Direct exposure to leading US cardiology centers and the FDA Breakthrough Devices process