Senior Clinical Trial Manager
A globally active biotechnology company is seeking to recruit a Senior Clinical Trial Manager to their office in Berlin. The organisation is known for its work across immune control and as a leader in bio-therapeutic products for cancer. This is an exciting opportunity to work for an organisation that develops innovative treatment options for patients.
- Overseeing Trial management of national and international clinical studies in accordance with GCP, applicable local laws, international guidelines, and SOPs.
- Providing regular status updates to the director of clinical development (and the senior management).
- Overseeing clinical trials regarding, but not limited to, status, budget, safety and quality.
- Preparing and contributing to clinical core documents (e.g. Investigator Brochure, Trial protocol, trial amendments, Patient information sheet and consent form, Case report forms and others).
- Setting up and maintaining the clinical trial database/tracker.
- Ensuring the setup and maintenance of the TMF/ISF (TMF is handled by CRO).
- Ensuring the timely submission of all required trial applications to Competent Authorities and Ethic Committees/Independent Review Boards.
- Organizing and conducting investigator meetings.
- Supporting the process of country and ensuring site selection.
- Overseeing Vendor and CRO management, serving as main contact for outsourced activities, and managing CROs, if applicable.
- Conducting Co-Monitoring visits, as applicable.
- Supporting preparation, conduct, and follow-up of GCP audits and GCP inspections.
- Supporting the director of clinical development on program level documents.
Skills and Requirements:
- Natural/life sciences or medical background (university degree or experience in a medical profession, such as Nurse, Medical Technical Assistant or Pharmaceutical Technical Assistant).
- Profound knowledge and experience in relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects.
- Minimum 3 years (5 years is a minimum for the senior position) of experience in clinical trial management with practice in project planning and structuring on CRO or sponsor side.
- Experience with regulatory submissions, monitoring of clinical trials, (immune) oncology is a plus.
- Very good German (written and spoken) is a plus.
- Sound understanding of clinical evaluations and regulatory affairs processes.
- General understanding of R&D processes especially in Biotech companies.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Julia Tegelmann at +44 203 854 1052 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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