Project Manager Clinical Operations, 80-100% (ID1768)

The Clinical Operations Project Manager is responsible for the planning, execution, and oversight of clinical studies, ensuring they are conducted in compliance with regulatory requirements, timelines, and budgets. In this role, you will work closely with cross-functional teams and collaborate with internal and external stakeholders to drive the successful delivery of clinical research outcomes, supporting AO's mission to improve patient care. The ideal candidate will bring strong expertise in clinical research project and stakeholder management, along with excellent interpersonal and communication skills.

• Plan and manage clinical studies within the framework of scientific and legal guidelines.
• Lead study teams including various function roles.
• Prepare project budgets and be accountable for adherence of project budget and timelines throughout the conduct of the project.
• Provide regular updates on study progress to AO ITC management and sponsors as required.
• Foresee and communicate deviations from the project plan, propose corrective actions, coordinate and execute them effectively.
• Prepare, coordinate, oversee and if required, conduct site initiation visits, monitoring visits and site close-out visits including report review.
• Coordinate and develop essential documents for the execution of clinical studies.
• Oversee the quality control processes for clinical data, including data validation.
• Compile and archive study documents.
• Maintain contact with study site personnel (Principal Investigators and Study Nurses).
• Coordinate and manage external vendors supporting the studies.
• Evaluate clinical data in collaboration with the Biostatistician, the Medical Advisor, and the Medical Writer.
• Fulfill tasks independently by adhering to applicable guidelines.
• Contribute to continuous improvement of the internal landscape related to clinical studies.
• Support the division in achieving its goals.

• University or similar degree (Masters or PhD in a relevant life sciences discipline).
• Understanding of ICH-GCP.
• Experience in managing clinical studies and basic medical knowledge.
• Two years of practical experience with project management, including stakeholder management.
• Good time management and analytical skills.
• Ability to work both independently and in a team.
• Demonstrated ability to collaborate effectively within a team environment.
• Flexibility and a customer-focused mindset.
• Good financial acumen (budgeting).
• Strong written and oral communication skills in English.

Nice-to-haves:

• Understanding of ISO14155 and ISO9001.
• Experience in managing clinical studies in industry.

• An interesting and varied job in an exciting and innovative organization
• The opportunity to be part of a highly committed international team
• Modern infrastructure
• High degree of flexibility regarding working hours and location (depending on operational requirements)
• Generous pagacke of social benefits, including supplementary vacation days and pension scheme contributions
• Internal skills training opportunities and support for continued education