Clinical Trial Leader
Date Posted: Wednesday, 21st of July 2010
Salary: Excellent
Start Date: ASAP
Telephone: 01438 743047
Location: Surrey
Consultant Name: Jonathan Hart Smith
Sector: Clinical
Description
Clinical Trial Leader
You will Provide leadership and line management to monitor and supporting staff within the Country. To achieve production of high quality clinical trial data to support the goals of the Country Clinical Development Plan, consistent with international regulatory requirements for new drug applications. This includes implementation of clinical re-search activities for all clinical trials, Phases I - IV, ensuring quality, time-lines and budget targets are met and by working closely with local medical affairs / Regional clinical teams and marketing to assure optimal investigator and key opinion leader development is achieved.
Major Accountabilities:
- Set and meet specific targets for clinical trial budget and patient recruitment.
- Evaluate the resources needed vs resources available for the clinical trials running and planned.
- Plan and control the allocation of trials to ensure maximum efficiency and timely completion of work.
- Provide strategic input^aimed at ensuring continuous improvement in the way we operate and implement Standard Clinical Operating Procedures relevant to the purpose of the position.
- Assess efficiency of field monitoring processes / administration procedures, recommend and implement agreed improvements.
- Participate in Clinical Operations activities including preparation of trial-specific monitoring manuals, procedures, operational guidelines etc.
- Provide operational input to clinical trial protocols as required.
- Interact with local Medical, Marketing and other key players to allocate trials (both regional and local as appropriate), to best support international and local Country interests.
- Approve the selection of suitable trial centers for theplacement of clinical trials in their Country, including the approval of grants.
- Report on status of actual vs planned recruitment from all centers participating in trials in the Country.
- Lead, motivate, set objectives managing performance to^assure completion of goals and develop staff to improve their individual performance and that of their unit as a whole. This can include conducting individual and complete performance re-views, monitoring professional development plans, and make salary recommendations.
- Ensure that prevailing legislation, GCP, Ethical Committee, and standard operating procedures requirements are fulfilled and monitor adherence to and compliance with standard operating procedures
