Clinical Operations Manager
POI seeks a Clinical Operations Manager to work full time in our Ascot office. The COM will manage all CRAs and Project Managers and assist clinical staff in the timely set-up, recruitment and completion of clinical studies. The COM will also work across departments to ensure a smooth working relationship between Clinical Operations and Business Development.
Key Responsibilities & Critical Objectives
- Liaise with Business Development to ensure smooth handover of clinical studies to Clinical Operations.
- Provide expertise and guidance to project teams.
- Ensure that SOPs and ICH - GCP Guidelines/FDA regulations are rigidly implemented in clinical trials managed by POI.
- Advise, support and motivate project teams in the management of the assigned clinical trials.
- Monitor and appraise the performance and compliance of POI clinical staff and/or sub-contractors in conducting their agreed objectives and /or their contractual obligations.
- Liaise regularly with the Director of Clinical Operations on all clinical issues, both personnel and project.
- Prepare and review written objectives and conduct performance assessments of each CRA and Project Manager at intervals no greater than six months.
- Maintain an overview of clinical studies to identify potential pitfalls and resolve project related issues on an ongoing basis.
- Participate in the selection process e.g. formal interviews of potential POI project team staff.
- Organise task teams to review current procedures and practices employed by POI, and to propose alternative methods that are potentially more efficient cost effective and/or improve the quality of clinical trials managed by POI.
- Attend and present at selected meetings or courses which may impact on POI business and development, have project specific importance or major implications for the future conduct of clinical trials.
- Support POI Business Development and provide in-house scientific/clinical expertise and co-attendance with marketing executives at promotional events/exhibitions.
- Act as Head of Clinical Operations in the absence of Director of Clinical Operations.
Please send CV and salary requirements to Pharm-Olam International (UK) Ltd. - The Brackens, London Road - Ascot, Berkshire, SL5 8BJ UK or e-mail to hr-uk@pharm-olam.com. NO PHONE CALLS PLEASE. |