Closing Date: 07 Nov 16
Salary (£): Competitive
Benefits: Full Corporate Benefits package
Top Global Pharma
Innovative, ethical and supportive working environment
Excellent transport links and onsite parking
The Senior Manager Clinical Operations will be responsible for but not limited to the following:
Has primary accountability for operational study level time, cost and quality deliverables
Manages overall study budget – for large, global or multiple regional studies
Coordinates all operational clinical research activities for regional / global studies
Manages all aspects of study progress from start-up to close-out activities in accordance with ICH/ GCP guidelines
Contributes to preparation of teams and documents for inspections
Contributes to the development and/ or review of high level study related documents (e.g., PCS, Protocol, CRF etc.)
Oversees the development of study manuals and monitoring manuals
Serves as primary interface with CROs to ensure appropriate study/operational strategy is followed
Selects / approves monitoring CROs and study sites
Evaluates vendor proposals against company’s terms and critical needs and partners with internal functions to define scope of work
Manages CROs for successful conduct of the clinical trial and assesses contractual
QUALIFICATIONS / EXPERIENCE REQUIRED:
· Science graduate
· Prior experience as a Clinical Study Manager
· Proven track record of leading cross-functional teams, people coordination, mentoring of junior colleagues.
· Experience in Neuroscience indications and especially Alzheimers disease preferable but not essential
· Experience in budget management
· Experience of CRO and technical vendor management essential to ensure delivery of complex multi-national outsourced studies to time and budget.
· Full understanding of current ICH/GCP guidelines.
For a confidential discussion please telephone Andrea Litovszky at AXESS Limited on 020 8560 2300. To apply, please click the Apply for job button quoting reference PW-6736.
Only candidates with EU work authorisation will be considered.
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AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
Visit us at www.axess.co.uk
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Richmond upon Thames,
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