Clinical Trial Manager
A global and innovative healthcare company is looking for three Clinical Study Manager to join their dynamic team. The company is focused on the development of innovative products and medical devices that address high unmet medical needs. Based in London, this is an exciting opportunity to bring expertise to a company that is creating new products for better health worldwide.
- Participating in CRO partnership activities to ensure smooth operationalisation, running and completion of clinical study/studies.
- Establishing communication flow with CRO and investigative sites to maximize compliance with study protocol.
- Developing protocol outlines, protocols, amendments and CRFs.
- Coordinate budgeting, timelines and vendor selection for the implementation of clinical study/studies.
- Ensuring studies are conducted in accordance with all applicable legal and regulatory requirements.
- Managing, coordinating, and providing ongoing assessment, evaluation, and communication with internal and external stakeholders, other departments (e.g., Regulatory, Drug Safety, and Clinical Trial Materials) and external vendors to ensure study objectives/timelines are accomplished.
- Supervising clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance
- Providing management personnel with timely updates on progress and changes in scope, schedule, and resources as required.
- Operational oversight that serious adverse events and follow-up reports have been reported to the regulatory authorities and ethics committees in accordance with regulatory requirements.
- Engaging in Inspection readiness strategies and activities.
Skills and Requirements
- Minimum of Bachelors' degree in pharmacy or equivalent.
- 3-4 years experience in the pharmaceutical/biotechnology industry
- 5+ years demonstrated work experience of successfully managing clinical trials with CROs
- Experience in management of international or global clinical trials required.
- Knowledge of regulatory requirements relating to Clinical Research.
- Ability to plan and execute a clinical trial from an operational perspective.
- Possess advanced computer skills (Microsoft applications, spreadsheets, etc.)
- Cross-functional and cross-cultural awareness.
- Fluent in written and spoken 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.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 0207 440 0639 or upload your CV on our website -www.proclinical.com/send-cv
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.