Manager, ClinOps (OrphaCare)

Vollzeit Unna

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
Willingness to travel at least 1 week a month to our Vienna office

Our offer

Join a high-performing team within an open, collaborative corporate culture that encourages initiative and the contribution of new ideas.
Benefit from a structured onboarding process and ongoing training opportunities to support your professional development.
Enjoy a bonus scheme and comprehensive benefits
Access continuous personal and professional development opportunities within an international environment.

APPLY NOW

Please submit your application exclusively via the application link.