Director of Clinical Operations - Mainz, Deutschland - Proclinical
Beschreibung
Proclinical are recruiting for a Director of Clinical Operations to join a biotech organisation. This role is on a permanent basis and is located in Germany.Responsibilities:
- Monitor actions connected to the heading of the project teams, the oversight/control of thirdparty providers, the performance of all services in a timely manner as well as shareholder management of all divisions included.
- Supervise the development and evaluation of portfolio documents, for example: oversight plans, process developments and SOP development.
- Serve as the main point of contact when escalation of challenges in platform or vendorlinked activities occur within other divisions or external vendors,
- Partake in the procedure of selection and decision on contribution of vendor, ideally vendors and partnership vendors.
- Responsible for team developments and recognising highperforming team members.
- Guarantee that adherence to the regulatory needs, the ICH-GCP regulations and the respective processes such as policies, SOPs, instructions, etc.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a natural/life science or medical field or familiarity working in a nurse, medical technical assistant or pharmaceutical technical assistant role mixed in with demonstrable experience in project management, regulatory proposals and international study organisations.
- Acquaintance with oncology or infectious diseases would be ideal.
- Knowhow of pertinent legislation and global regulations such as ICH-GCP for the conduct of clinical research projects.
- Past involvement with preparing and processing both national and global projects under consideration of the local laws, global regulations such as ICH GCP and suitable SOPs.
- Communication skills both verbally and in writing.
- Able to resolve issues.
- Capable of quickly getting into actions and work under stressful conditions.
- A motivated individual who can guide a team.
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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Clinical
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