Clinical Trial Manager
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Holbæk
Are you looking for the possibility to unfold your ambitions within clinical operations even further? Do you thrive in an innovative environment working alongside dedicated clinical research professionals? Are you a self-driven team player, who enjoys a varied and influential day at work?
Then we are also looking for 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 take pride in an open and friendly work environment, with great flexibility and opportunities. We expect the team to expand even further, in the coming period, and look forward to welcome you, to our team.
About the job
As our new Clinical Trial Manager, you will be driving a wide range of operational tasks and responsibilities, dependent on your level of experience, and in collaboration with the Clinical Project Director. Your primary responsibility will be to manage and coordinate global clinical trial management activities, in collaboration with selected CROs/vendors, and therefore the position requires frequent interactions with CROs/vendors and other in- and external stakeholders. The Clinical Trial Manager also provides operational expertise to the core trial teams, and should expect to have great influence on developing our clinical operation processes.
The Clinical Trial Manager 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.
- Conduct ad hoc co-monitoring visits
- Ensure close communication on trial progress with relevant stakeholders.
- Contribute to development and maintenance of clinical operations processes.
- Drive the CRO/vendor management on a trial level.
About you
You have a relevant, pharmaceutical, scientific or health related educational background. You have some experience (+3 years) with clinical operations and managing ICH GCP regulated clinical trials from start till finish, from a pharmaceutical or biotech company, from a CRO or as a freelance consultant.We expect you to have experience with contract management, whereasexperience with managing international projecs, is considered an advantage.
In addition, we expect you to:
- Be capable of assuming responsibility and drive projects to successful outcomes.
- 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 "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 5.4.2023, 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.
- Øvrige
- Holbæk
- Onsdag den 17. maj 2023
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