Our client, based in the UK, is a well funded, small, rapidly growing and ambitious speciality pharma company currently at a very exciting stage in its life.
With two innovative products already in phase III and others in Phases I and II, they are optimistic of being in a position to make initial regulatory submissions later this year that would then allow for subsequent commercialisation of their first product late 2017 / early 2018.
The need has emerged for a talented, motivated and experienced Senior Clinical Project Manager to join the company in what is a critically important role.
This is an Interim role, likely to be (initially) of 6 months duration and demand 3-4 days / week. For the right person, this has the possibility of subsequently transitioning into a permanent role.
The successful candidate will primarily be working from a home base, but visits to the CRO will clearly be important as will occasional visits to the company’s offices in London.
Reporting directly to the company’s Medical Director, and working primarily on at least two Phase I studies, key areas of responsibility are as follows:-
- Provide the necessary expertise to support the company by providing clinical project management (including planning, implementation and execution) for the Company’s key development programmes
- Specifically, to manage clinical studies to ICH-GCP standards, UK Statutory Instrument requirements and in line with the Company’s SOPs
- To manage or participate in the selection process for clinical CROs; to assist in the preparation and review of study protocols and other study specific documentation
- To ensure consistency in protocol and CRF design, data management processes and related study specific documentation; to act as single-point of contact with the appointed clinical CROs conducting the Company’s studies
- To ensure sufficient resources are available to manage and monitor the Client’s studies
- To review clinical monitoring plans in accordance with the Company’s SOPs
- To co-ordinate monitoring of clinical studies in accordance with pre-prepared monitoring plans
- To co-ordinate the supply of study medication including facilitating the forecast, distribution, returns and destructions of such material
- To track study progress and report any issues to the Medical Director or Quality Manager
- To assist in the writing, compilation and/or review of clinical SOPs; to maintain an understanding of the external environment for conducting clinical research in Europe.
This is an excellent opportunity in an outstanding company of real potential - one with whom Interea has worked many times in the past.
If this is of interest to you, please contact Geoff Newman of Interea International as soon as possible. Phone 01844 – 202989 or email to email@example.com