Ref #: 25485

Employment type: Permanent - Full-Time

Location: Home-Based, UK

Posted: 27-Nov-2020


In this new role with the Study Start-Up Team in Site Management and Monitoring, UK, you will actively support the coordination and set-up of clinical studies by working across the Local Study Teams (LST) whilst ensuring quality and consistency of study deliverables to our time, cost and quality objectives.

Our client’s clinical studies span a range of therapeutic areas including respiratory, oncology, cardiovascular and metabolic diseases. You will play an important role in driving the costings and contracts negotiations for our clinical studies during set up and also modifications required as a result of protocol amendments. You will have regular communication with hospital trusts and study team members at our trial sites as well as other key external and internal stakeholders.

You will be responsible for negotiating costings and contracts across our clinical studies from start-up through execution and close-out.
Specific tasks could include:
• Drafting financial and study agreements with Investigators and Trusts / Health Boards
• Negotiating costings with Trusts / Health Boards and private health care institutions, covering the NIHR costings template and maintaining appropriate records to support improving efficiencies in future negotiations with key sites
• Driving the prompt review and approval of contracts and costings with external and internal stakeholders
• Assisting in preparation, review and tracking of documents for the clinical trial application process (regulatory and ethics).

• Previous costings and negotiation experience gained within a healthcare / pharmaceutical environment (for example as an R&D contracts manager)
• Excellent communication, negotiation and influencing skills
• Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities