Our client, a European pharmaceutical company are currently looking for a Clinical Project Manager to join their UK team on a contract basis. The main purpose of this role will be to manage a Phase IV study for an oncology product in primary care. Liaising closely with the Clinical Research Manager, your main responsibilities will be to:
- Oversee the production of clinical documentation (Protocols, CRFs, PCT Applications, Ethics Submissions).
- Manage the project team activities (co-monitoring etc)
- Select and manage CROs.
- Ensure the supply of IMPs.
- Prepare, monitor and manage study budgets.
- Ensure absolute compliance with internal SOPs and ICH GCP guidelines.
The successful candidate will be educated to a minimum degree level in a Life Science or Nursing related subject. The following attributes are also essential for this Clinical Project Manager role:
- Experience of the management of Phase II – IV trials
- Experience of working with Primary Care Trusts
- Proven ability to prepare Clinical Trial Protocols and related documentation
- A background in study set-up (feasibility, site selection, PCT applications)
- Line management experience
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