Head of Clinical Operations
Company: ProClinical Ltd
Closing Date: 28 Oct 16
Salary (£): Competitive
ProClinical is seeking a Head of Clinical Operations on behalf our our client, a growing biopharmaceutical company based in Germany. The company has an exciting pipeline and focuses on developing breakthrough treatments for cancer and immunotherapy. This role will be based at their offices in Germany. ...
ProClinical is seeking a Head of Clinical Operations on behalf our our client, a growing biopharmaceutical company based in Germany. The company has an exciting pipeline and focuses on developing breakthrough treatments for cancer and immunotherapy. This role will be based at their offices in Germany.
- Operational oversight of all clinical activities and the clinical operations budget
- Contact person to third parties supporting operation activities for the company
- Planning of clinical phase I and II studies
- Managing the identification and selection of investigators for clinical studies and managing clinical trial sites
- Managing external contractors to ensure adequate service provision including screening, selection, and budget negotiation with service providers (CRO, EDC, PVG, Central Pharmacy)
- Coordinating vendor meetings and reviewing vendor documents (e.g., manuals, Master Service Agreements, contracts) for adequacy
- Liaising with other departments involved in the development process
- Definition, development and implementation of the processes relevant to the clinical operations
- Developing project plans to include timelines and milestones
- Preparing clinical documents (e.g. protocols, study reference manuals, documents for regulatory agencies or ethics boards), standard operations procedures, guidelines, and departmental policies
- Implementing and executing in a timely manner and to a high standard, all aspects of the company's clinical studies in compliance with regulations, GCP and SOPs
- Supporting the regulatory requirements of clinical development programs and studies
- Ensuring ethical and regulatory requirements are met
- Managing the preparation of documents such as Ethics Committee Applications and Clinical Trial Applications
- Establishing and maintaining optimum working practices to ensure timely and efficient delivery of clinical development programs and studies
- Ensuring development and availability of personnel (internal and external) with the right competencies, skills and experience to successfully deliver clinical development programmes and studies in a timely manner, within budget and to a high standard
- Excellent understanding of clinical operations procedures, at least 10 years of experience in clinical operations
- Prior experience with managing large multi-center studies with a keen understanding of all aspects of Clinical Operations, including: clinical trial design, study implementation/start-up activities, CRA and site management, data management (to database lock and data analyses)
- Strong experience in leading internal, external teams and in vendor management
- Excellent understanding of GCP and international regulations regarding clinical studies
- Management of CROs and other service providers
- Focused and able to meet tight timetables
- Ability to travel including international travels
- Should have both interest and experience in medical writing (e.g. protocols, study reports) and in analyzing data during and after the conclusion of studies
- Excellent communication and presentation skills
- Fluent in English
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.
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.