Director of Clinical Operations

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 third-party 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 vendor-linked 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 high-performing 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.
• Know-how 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.

If you are having difficulty in applying or if you have any questions, please contact Auxanne Rameix at +44 203 954 7011.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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