Senior 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 processes will make a difference?
Do you thrive with a wide range of responsibilities and are you able to keep excellent oversight and same time dive into details?
Look no further and come join us!
Clinical Operations is part of Clinical Development 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 with our colleagues in Data Management, Medical Writing, Clinical Science, Pharmacovigilance, and Clinical QA as well as with selected CROs/vendors.
As our new Senior 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 development and maintenance of our clinical processes, and to drive processes related to TMF development and management.
The role will be focused on human GCP/clinical trials but may also have responsibilities related to veterinary GCP/clinical trials.
The position reports to Director of Clinical Operations.
Key responsibilities:
You have a relevant, pharmaceutical, scientific, health related or other relevant educational background. We expect you to have previous GCP- and clinical trial experience from a pharmaceutical, medical device or biotech company, where you have worked with e.g., clinical processes, TMF management, quality management, QA/QC, clinical development/operations. As you, in cooperation with the team, will ensure the Quality Management system are maintained, a robust insight in clinical project management will be an advantage. In addition, we expect you to:
Be fluent in English, both written and spoken.
Genux Executive is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Tina Lorenzen, on [email protected].
Your CV (in English) should be submitted to [email protected] as soon as possible and no later than 6th of March , 2024.
Do you thrive with a wide range of responsibilities and are you able to keep excellent oversight and same time dive into details?
Look no further and come join us!
About the team
Clinical Operations is part of Clinical Development 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 with our colleagues in Data Management, Medical Writing, Clinical Science, Pharmacovigilance, and Clinical QA as well as with selected CROs/vendors.
About the job
As our new Senior 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 development and maintenance of our clinical processes, and to drive processes related to TMF development and management.
The role will be focused on human GCP/clinical trials but may also have responsibilities related to veterinary GCP/clinical trials.
The position reports to Director of Clinical Operations.
Key responsibilities:
- GCP quality management
- Overall responsible for developing our clinical processes and operational procedures.
- Responsible for monitoring Quality Regulatory Intelligence and ensuring training of colleagues on new approaches/actions.
- Drive, facilitate and execute procedure/SOP writing based on regulatory intelligence and input from colleagues.
- Develop Standards for Procedure and Process Management while ensuring GCP compliant formats.
- Ensuring GCP inspection readiness within quality management
- Super user of QMS system.
- TMF management
- Drive and manage development and implementation of new Trial Master File index.
- Responsible for ensuring a process for implementation of new TMF-index and maintenance including needed procedures.
- Responsible for implementing a QC procedure for TMF maintenance.
- Quality Control
- Driving quality management tasks across global clinical trials, including development and execution of QC plan.
- CTIS management
- Basic understanding of the processes.
- Taking on the role as Administrator ensuring that stakeholders (CTIS management are outsourced to CROs).
About you
You have a relevant, pharmaceutical, scientific, health related or other relevant educational background. We expect you to have previous GCP- and clinical trial experience from a pharmaceutical, medical device or biotech company, where you have worked with e.g., clinical processes, TMF management, quality management, QA/QC, clinical development/operations. As you, in cooperation with the team, will ensure the Quality Management system are maintained, a robust insight in clinical project management will be 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 and self-driven individual
- Strong skills in building and maintaining collaborative relationships to achieve shared goals.
- 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.
- Many talented and dedicated colleagues across functional disciplines.
- Inspiring and flexible working environment including possibility to work from home 2-3 days a week.
- An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth.
- A competitive compensation package.
Additional information
Genux Executive is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Tina Lorenzen, on [email protected].
Your CV (in English) should be submitted to [email protected] as soon as possible and no later than 6th of March , 2024.
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 14.2.2024, 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
- Onsdag den 06. marts 2024
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