clinical project leader - bio
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Should you be interested in the above position and wish to apply, please send your application with your CV,
quoting the above reference number, to our recruitment team at [email protected]
CTC Resourcing Solutions, 117 Waterloo Road, SE1 8UL, London, UK Tel.: +44 207 193 9972 www.ctcresourcing.com [email protected]
Providing Flexible Resourcing Solutions CTC Resourcing Solutions, founded 1997, is a pan-European specialist staffing organisation with offices in London, Basel and Munich, providing flexible resourcing solutions to the pharmaceutical industry across Europe, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing For a key client, we are currently looking for a:
Clinical Project Leader Reference Number: 893073-W Type of placement: Contract or Permanent Location: Oxfordshire, UK Our client is an independent clinical-stage biopharmaceutical company focused on developing a portfolio of therapies for the treatment of allergies. With several treatments currently in development, a number of products are in early-stage stage trials with the most advanced compound currently in phase III. The company requires an experienced Clinical Study Manager to lead a programme of outsourced international trials with accountability for the budget, timelines, quality and reporting of allocated studies. This is an exciting opportunity to work for a young and progressive company whose ultimate ambition is to build a successful immunotherapy company, improving patients’ lives around the world. Main Responsibilities:
Project Management of all clinical aspects of clinical studies (all phases) in Europe and North America to ensure successful completion of clinical studies on time and within budget.
Management of third party suppliers.
Review of monitoring reports, study plans (DMP, SAP, project plan, etc).
Review and/or preparation of protocols, Investigator Brochures, Clinical Study Reports.
Attendance at Investigator meetings, Site Initiation Visits.
Co-monitoring with CRO CRAs. Qualifications and Experience:
Bachelor’s degree or equivalent in a biomedical or life sciences discipline
Demonstrated study management experience in clinical or pharmaceutical development
Minimum 6 years’ experience in clinical research, with strong Clinical Project Management experience.
Competence to identify challenges and risks and suggest/implement appropriate actions.
Experience in maintenance of study timelines and vendor management activities.
Experience in managing all aspects of clinical studies and clinical development
Working knowledge of international regulatory and ICH GCP guidelines
Highly effective verbal and written communication/presentation skills in English.