We are looking for a Manager, ClinOps at OrphaCare to drive the successful planning, execution, and oversight of clinical investigations for innovative Class III medical devices. In this role, you will act as the operational lead across all clinical trial activities—from study start-up to close-out—ensuring high-quality, compliant, and timely delivery in line with regulatory requirements and company standards. You will work cross-functionally and with external partners to translate clinical strategy into operational excellence.

What Your Day To Day Will Look Like

• Lead end-to-end operational planning, execution, and oversight of clinical investigations
• Translate clinical investigation plans into detailed operational strategies, timelines, and deliverables
• Manage study start-up, site selection, feasibility, and activation activities
• Oversee site management, study logistics, and documentation (including eTMF readiness)
• Act as primary operational contact for investigative sites and ensure effective communication and training
• Ensure studies are conducted in accordance with ISO 14155, EU MDR, ICH-GCP, and internal SOPs
• Drive vendor and CRO selection, contracting, onboarding, and performance management
• Monitor vendor deliverables, KPIs, budgets, and timelines in collaboration with internal stakeholders
• Coordinate cross-functional teams (e.g., Clinical, RA, QA, Data, Statistics, Safety, R&D)
• Ensure inspection readiness and support audits and regulatory inspections
• Identify and escalate risks related to quality, timelines, or compliance
• Maintain study trackers, documentation, and operational reporting

Your Qualifications And Experience

• Minimum 5 years of experience in clinical operations or clinical project management
• Proven experience in managing clinical studies, including vendor oversight and cross-functional coordination
• Strong experience in medical device clinical investigations (Class III/high-risk devices preferred)
• Solid knowledge of ISO 14155, EU MDR 2017/745, and ICH-GCP/GxP standards
• Experience with CRO/vendor management and inspection readiness
• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Medicine, or a related field
• Fluency in English (written and spoken); additional languages are an advantage
• Strong organizational skills, attention to detail, and ability to manage complex projects
• Excellent communication skills and ability to work effectively in a matrix environment

Our offer

• An open corporate culture with the opportunity to contribute your own ideas
• Working independently in a collegial and committed team
• Modern working environment with good public transport connections (U4 - Heiligenstadt)
• Flexible working hours (flexitime/time-out days), bonus scheme, additional benefits and employee events
• Structured onboarding and support through a buddy system
• Due to legal requirements, we are obliged to disclose the collective agreement minimum salary, which is EUR 45.080,- gross per year, based on full-time employment. However, our actual remuneration packages are market-oriented and aligned with your qualifications and professional experience.