Job Description
We are looking for a
SENIOR CLINICAL PROJECT MANAGER (M/F/D)
- Plan and manage all components of a clinical trial, leading a cross-functional study team and provide study status updates and reports to senior management
- Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards and SOPs
- Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites
- Guarantee Audit and Inspection Readiness working closely with QA, e.g. oversee implementation and maintenance of Trial Master File
- Review invoices and track study budget according to the forecast, working closely with Finance and Clinical Business Operations
- Participate in selection and lead management of external vendors in particular CRO`s with oversight of activities
- Develop study documents and tools including informed consent forms, project plans, budgets, study logs, templates, and other materials as needed
- Participate in ongoing study data reviews and data cleaning activities and participate in external meetings where this data is discussed and/or presented (e.g., Investigator Meetings, conferences and events)
- Develop and deliver study training to investigators, site staff, and internal staff on select study processes
- Participate in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as Regulatory Authority inspections
- Develop or contribute to SOP development and best practices and facilitate their implementation, as needed
- Established Cell Therapy /TCR study experience required
- S. Degree with minimum 7+ years of experience managing clinical trials preferably in biotech, or pharmaceutical, and/or CRO environment
- Strong early phase clinical study conduct experience from start-up through close-out, with global trial and CRO management experience. Demonstrated experience with various phases of clinical development is a plus
- Established knowledge of Clinical Operations
- Working knowledge of relevant GCP and FDA/EMA regulations
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials
- Travel up to 30% - ability to travel domestically and internationally
- Experienced in using project management tools
- Strong leadership, effective decision making, and problem-solving skills required
- Munich/Germany based preferred
- Flexibility with working hours to interact with the team in the US (2-3 days/week)
- Excellent verbal and written communication skills in English (required), German is a plus
- A company which is dedicated to help patients, and where your contribution can make a difference.
- A company where every employee has an impact and both team and individual contributions are seen and rewarded
- Work within and shape an innovative and growing company by bringing in your ideas and experience
- Grow within a multidisciplinary project team at the interface to R&D, CMC, (non-)Clinical Development, Finance and Quality Assurance
- A great working atmosphere and flat hierarchies with direct report to the Head of Clinical Development
- The opportunity to work hybrid
- An unlimited contract with 30 days of paid vacation