Clinical Project Director
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Holbæk
Are you a development-oriented and self-driven team player with extensive clinical trial management experience? Do you share our passion for clinical research, and would you like to work in a flexible and innovative working environment, in a growing pharmaceutical company?
If now is the time to move on – we would like to hear from you!
About the team
Clinical Development is responsible for end-to-end clinical project activities, including clinical operations, medical writing, data management, biometrics and contract management. We are responsible for both human and veterinary clinical trial activities within our clinical development program. The program includes global phase I-IV trials in iron deficiency and anemia, treatment of transfusional iron overload and other iron mediated conditions with our new development compound, as well as cryopreservation of a variety of cell lines. We work closely together with our colleagues in Regulatory Affairs, Pharmacovigilance, QA and Marketing, as well as with selected CROs/vendors. Currently, we are a small, but dedicated team of 6 highly experienced clinical project professionals, and we look forward to welcome you, to our clinical operations team. We expect the team to expand even further, in the coming period. We are driven by a high level of professionalism, an open-minded approach, where everyone contributes to knowledge sharing, in a fun and flexible working environment and friendly atmosphere.
About the job
As our new Clinical Project Director, you will have an independent role with a wide range of operational tasks and responsibilities. Your primary responsibility will be to manage and coordinate global clinical trial management activities and to provide operational expertise to the project or trial teams. All our clinical trials are conducted in collaboration with selected CROs/vendors, and therefore the position requires frequent interactions with CROs/vendors and other in- and external stakeholders.The Clinical Project Director should expect to have large influence on designing and developing our clinical operation processes. For the right candidate, this is a unique opportunity to join an innovative pharmaceutical company, and help build our clinical operations team.
The Clinical Project Director reports to the Director of Clinical Operations.
Key responsibilities
- Lead, manage and co-ordinate the conduct of international clinical trials from start-up to close-out
- Manage trial budgets, timely deliverables and quality
- Develop and review clinical trial related documents (e.g., protocols, CRFs, manuals), in collaboration with CROs/vendors and other in- and external stakeholders
- Overall responsible for operational clinical trial management tasks, incl. Trial Master File maintenance, monitoring guidelines, recruitment and retention strategies, risk management plans, communication plans etc.
- Ensure oversight of CROs/vendors including planning, monitoring process and documentation.
- Ensure close communication on trial progress with relevant stakeholders
- Contribute to development and maintenance of clinical operations processes
- Drive the CRO/vendor selection and management on a trial level
About you
You have a relevant, pharmaceutical, scientific or health related educational background. You have extensive experience (+8 years) with clinical operations and managing international ICH GCP regulated clinical trials from start till finish, from a pharmaceutical, or biotech company, from a CRO or as a freelance consultant.Preferably you also have a few years of experience with international project management.
In addition, we expect you to:
- Be capable of assuming responsibility and drive projects to successful outcomes.
- Have experience with R&D contract management
- Be a proactive, highly motivated and self-driven individual.
- Bring oversight and strong organizational skills.
- Be able to work independently and effectively with a problem-solving attitude.
- Have good communication skills.
- Be able to prioritize between different tasks in a dynamic environment.
- Be a dedicated team player with a high degree of flexibility and cross-cultural awareness.
- Bring strong skills in building and maintaining collaborative relationships to achieve shared goals.
- Have a high-quality mindset.
- Have good computer skills and the ability to learn appropriate software.
- Be fluent in English, both written and spoken
We offer
- An independent and influential function in global settings, with a broad range of tasks and responsibilities.
- An opportunity to join a small and dedicated team with an open and friendly atmosphere.
- A large number of talented and dedicated colleagues across functional disciplines.
- Inspiring and flexible working environment.
- An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth.
- An attractive and competitive compensation package.
Contact
Ontops Recruitment & Development is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Berit Tops, on +45 2174 2322. Interviews will be held on an ongoing basis, so please submit your application and CV (in English) as soon as possible. Click on the blue button at the top right to apply.
Information og data
Denne ledige stilling har jobtypen "Direktør", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 17.11.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Direktør
- Holbæk
- Fredag den 28. april 2023
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