(Sr.) Clinical Process Manager
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Holbæk
Do you have experience with clinical trial processes and are you looking for an influential job opportunity, where your passion for quality and GCP compliance will make a difference? Do you thrive with a wide range of responsibilities and are you able to keep excellent oversight?
Look no further and come join us!
Pharmacosmos is a progressive and innovative pharmaceutical company with headquarters in Holbæk, Denmark. We are on an exciting journey of global growth, and therefore we are expanding our capacity with a new colleague to the area of Clinical Strategy & Operations.
About the team
Clinical Strategy & Operations is part of R&D at Pharmacosmos, and is responsible for both human and veterinary clinical trial activities. We are a small team of experienced and dedicated clinical project professionals, and we are looking forward to welcoming you as an important part of the team. We work closely together with our colleagues in Biometrics and Medical Writing, Regulatory Affairs, Pharmacovigilance, QA and marketing, as well as with selected CROs.
About the job
As our new (Sr.) Clinical Process Manager, you will have an independent role with a wide range of operational tasks and responsibilities, dependent on your level of experience. Your primary focus will be to drive GCP quality management tasksacross Pharmacosmos’ clinical trials, including maintenance, development and implementation of SOPs for the area. Furthermore, the Clinical Process Manager will drive and manage the processes for the EMA CTIS system, and be involved in operational activities related to TMF management and R&D contract management.
The role will be focused on human GCP/clinical trials, but may also have responsibilities related to veterinary GCP/clinical trials. You will have regular contact with in- and external stakeholders.
The position reports to Head of Clinical Strategy and Operations.
Key responsibilities
- GCP quality management
- Maintenance and development of Pharmacosmos GCP quality processes for clinical operations
- Driving quality management tasks across global clinical trials, including development and execution of QC plan
- Ensuring GCP inspection readiness and management
- CTIS management
- Management of EMA CTIS system for submitting Clinical Trial Applications in EU and onboarding of CROs to the system
- TMF management
- Drive and manage development of electronic Trial Master File & related procedures
- R&D/GCP contract management
- Set up and manage contracts for R&D/Clinical, with external collaborators and CROs in collaboration with relevant stakeholders.
About you
You have a relevant, pharmaceutical, scientific or health related educational background. We expect you to have previous GCP and clinical trial experience from a pharmaceutical, medical device or biotech company, as a freelance consultant or from regulatory authorities, where you have worked with e.g., quality management, QA/QC, clinical development/operations.
Experience with R&D Contract Management and eTMF is an advantage.
In addition, we expect you to:
- Have excellent oversight and strong organizational skills.
- Be attentive to quality and detail.
- Be able to work independently and effectively with a problem-solving attitude.
- Be a proactive, highly motivated and self-driven individual.
- Have robust cross-functional teamwork skills.
- Bring strong skills in building and maintaining collaborative relationships to achieve shared goals.
- Be capable of assuming responsibility and ownership of tasks with the ability to drive projects to successful outcomes.
- Have good computer skills (MS Office, databases, document management systems) and the ability to learn appropriate software.
- Be fluent in English, both written and spoken.
we offer
- An opportunity to join a small and dedicated team with an open and friendly atmosphere.
- An independent and influential function in global settings, with a broad range of tasks and responsibilities.
- A large number of talented and dedicated colleagues across functional disciplines.
- Inspiring and flexible working environment supported by modern communication technology.
- An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth.
- A competitive compensation package.
How to apply
Information og data
Denne ledige stilling har jobtypen "Projektleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 5.7.2022, 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.
- Projektleder
- Holbæk
- Fredag den 05. august 2022
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