Company: inVentiv Health Clinical
Closing Date: 20 Dec 16
Salary (£): Negotiable
Join our Global Pharmaceutical client who is at the forefront of research. This role will be fully embedded within our clients Oncology Project management team.
inVentiv Health -Transforming Promising Ideas into Commercial Reality
Here at inVentiv Health Clinical we are recruiting for a Clinical Project Manager to be based with one of our global pharmaceutical clients.
This is an opportunity to play your role in contributing to the success of Oncology studies. In this post you will take lead of UK trials to ensure objectives are met within timelines and budget. Provide a central point of communication between global teams and director and lead trial teams.
- Provides a central point for communication between Global, Regional and UK Trial Team for delivery and management of Oncology trials according to timelines, budget and performance metrics.
- Directs and leads the UK Trial Team, cascades milestones to ensure trials undertaken meet or exceed targets.
- Monitors trial resource requirements, working with the CRA Manager to ensure trials are resourced appropriately.
- Drives Feasibility Review to evaluate new trials and coordinates feedback to the UK Medical Director and Country Head.
- Leads centre selection in conjunction with CRAs, Medical Scientific Liaison functions and selects appropriate sites.
- Provides protocol specific training to CRAs and supports with evaluation visits as required.
- Coordinates and attends investigator meetings as required.
- Writes and coordinates MREC submissions and attends MREC meetings as required.
- Accountable for ensuring distribution of all safety updates to investigators and MRECs.
- Communicates clearly with regulatory department regarding local regulatory submissions for CTAs.
- Completes Trial Commitment Forms assuring best outcome according to metrics and approves budget allocation.
- Negotiates contracts with CROs, SMOs and NHS Trusts as required.
- Management of the country level TMF and the creation and signoff of the Country level Table of Contents.
- Develops recruitment strategies and contingencies in conjunction with CRAs and Medical Team.
- Contributes to the design/writing of UK trial protocol, reports and publications where required and within agreed timelines and budget.
- Ensures local Phase IV studies are posted on the appropriate Registration and public databases.
- Develops and maintains relationships with KOLs and investigators.
- Completes Site Specific Worksheets (SSWs) for globally outsourced studies and is the main point of contact for the global team and CRO regarding UK management.
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