SENIOR CLINICAL PROJECT MANAGER (M/F/D)

Your Responsibilities

  • 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

Your Profile

  • 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

Our Offer

  • 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

We look forward to receiving your complete application under the reference number CPM01 via email human.resources@medigene.com

Medigene AG
Lochhamer Str. 11
D-82152 Planegg/Martinsried
www.medigene.com

Medigene is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. With its scientific expertise, Medigene is working on the development of innovative immunotherapies to enhance T cell activity against solid cancers in fields of high unmet medical need. Medigene’s pipeline includes pre-clinical as well as clinical programs in development.

We kindly ask recruitment agencies to refrain from contacting Medigene AG.