ProClinical is seeking a Clinical Project Manager for a global pharmaceutical company, this role will be a permanent position based in London. The Clinical Project Manager will act as Management of European clinical development of allocated compounds.
- Ensure studies are performed and completed in accordance with the budget, timelines and quality specification across all functions and in accordance with EU GCP and relevant MTPE and Global SOPs.
- Responsible for ensuring control of allocated project budgets
- Participate in CRO/vendor evaluation and selection and be responsible for making selection recommendations to SPM/DGM, in collaboration with Vendor Management.
- Oversee and, where appropriate, manage the activities of vendors performing studies for MTPE, including set-up of vendor contracts and oversight of scope of work.
- Coordinate the production of study documents or create study documents, as required, including but not limited to protocol, PIS/ICF, insurance, study plans, clinical study report, etc.
- Oversee all activities required up to SIV, including EC and Regulatory submissions and IMP Release Process (compilation of documents required for Site Regulatory Packages and provision of drug supplies).
- Ensure Trial Master File is set-up, maintained audit-ready and archived in accordance with MTPE SOPs and GCP.
- Participate in meetings with Key Opinion Leaders involved in research programmes in Europe and assist with planning for further development of allocated compounds, as appropriate.
- Chair internal and external study specific meetings and provide monthly study and summary reports with relevant study updates and also present study updates at monthly Senior Managers Meeting.
- Participate in the development of new SOPs and review of SOPs describing clinical activities.
- To keep up to date with significant new clinical research findings and regulatory guidelines in the relevant therapeutic areas.
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 call Jonathon Senior on +44 203 8569 334 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.