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Clinical Project Lead
vor 2 Wochen
Our client is a research institute -based on Nobel Prize winning technology- who are looking to revolutionize minimal invasive diagnostics in the upcoming years.
The purpose of the newly created Clinical Project Lead role is to build up and supervise their longitudinal clinical research program in Bavaria, Germany.
Responsibilities:
- Lead the development and execution of interventional clinical research program for non-IP diagnostic product.
- Provide program leadership to a cross-functional team.
- Identify and develop effective working relationship with key stakeholders, sites and vendors.
- Provide innovative and flexible operational solutions to study design, regulatory aspects, resource management, patient recruitment, study & site management activities.
- Oversight of QA and Regulatory activities to ensure compliance with legislation and company standards.
- Liaising with Competent Authorities as necessary.
- University degree in Life Sciences discipline (Medical Doctor or PhD is a plus)
- Proven track record in clinical project management in the pharmaceutical industry or academia in Germany
- Knowledge of ICH GCP and regulatory guidelines in Germany
- Proven ability to identify key stakeholder and build an effective clinical research network
- Demonstrated ability to think out-of-the-box and apply creative solutions to problems
- Ability to identify opportunities to accelerate results and build capability by assigning tasks to individuals with clear boundaries, expectations and support
- Fluent German and English
- Strategic thinking and ability to translate high level objectives to an operational plan and setting smart objectives
- Role is based in Munich, Germany