Manager, Clinical Research (m/f/d)

Your Profile:

• Bachelor's degree in Life Sciences, Health Sciences, Engineering, or a related discipline (required).
  
• 6-8 years of progressive experience in clinical research, clinical operations, or related medical device or healthcare research roles.
  
• Demonstrated experience managing or leading clinical studies and cross-functional teams.
  
• Strong knowledge of GCP, clinical research regulations, and quality systems.
  
• Proven ability to manage multiple priorities, timelines, and stakeholders in a matrix environment.
  
• Excellent written and verbal communication skills, including scientific and clinical documentation.
  
• Advanced degree (Master's or PhD) in a scientific or clinical discipline (preferred).
  
• Experience within medical devices, orthopedics, or surgical products.
  
• Prior people-management or matrix leadership experience.
  
• Experience supporting regulatory submissions or post-market clinical studies.
  
• Familiarity with global clinical trial execution and investigator-initiated research.
  
• Language: English proficiency required.

Your Tasks:

• Lead end-to-end clinical study operations across assigned programs, including feasibility planning, vendor/CRO engagement, start-up, execution, and close-out activities.
  
• Drive clinical site identification and selection by leading feasibility assessments (site experience, enrollment potential, quality history, contracting/start-up timelines), documenting rationale, and aligning final site lists with study strategy.
  
• Ensure studies are executed in compliance with GCP, applicable country regulations, and internal procedures, including oversight of informed consent, safety reporting, essential documents, and data integrity expectations.
  
• Serve as a primary clinical operations point of contact to cross-functional stakeholders (R&D, Medical Affairs, Regulatory, Quality, Biostatistics/Data Management) and external partners (CROs, investigators), ensuring timely decisions and clear documentation of actions and outcomes.
  
• Develop and maintain operational study plans (milestones, enrollment projections, monitoring strategy, issue escalation pathways), track progress against timelines and budget, and proactively identify/mitigate risks to deliverables.
  
• Own monitoring resourcing planning (FTE/visit forecasts, CRA allocation, coverage models) and coordinate with monitoring leadership/CROs to ensure adequate capacity, continuity, and quality oversight across sites.
  
• Support inspection readiness and participate in audits/inspections by preparing study documentation, coordinating responses, facilitating interviews, and driving timely completion of corrective and preventive actions (CAPAs) for study-related findings.
  
• Drive consistent project management and communication practices, including meeting cadences, status reporting, and lessons learned; collaborate effectively with a US-based global clinical team by planning across time zones and ensuring timely handoffs and stakeholder updates.

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