Reference: PW 6737
Closing Date: 10 Nov 16
Salary (£): Competitive
Benefits: Full Corporate Benefits package
Top Global Pharma
Innovative, ethical and supportive working environment
Excellent transport links and onsite parking
12 month FTC with the possibility of extension
The Manager Clinical Operations will be responsible for:
Ensures that the studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and company standard operating procedures.
May lead the cross-functional team for designated study(ies) and/or may coordinate designated regional aspects of assigned global study(ies) under supervision of study Global Clinical Operations Lead.
Mentors less experienced staff, although this position does not involve Line Management.
Clinical Trial Management:
- Has primary accountability for operational study level time, cost and quality deliverables
- Manages overall budget for a regional or smaller study (e.g. Ph II)
- Recommends sites to include or exclude from study
Clinical Trial Execution
- Independently oversees all operational clinical research activities for a study or series of small studies
- Oversees execution of studies according to ICH / GCP guidelines
- Contributes to inspection preparations
- May undertake co-monitoring activities
Document Creation and Management
- 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
CRO / Vendor Management
- Serves as first point of contact for company to CROs and/ or study sites for regional or smaller study (e.g., Ph II)
- Evaluates vendor proposals against company’s terms and critical needs and partners with internal functions to define scope of work
- Monitors and assesses vendor performance against contractual operational deliverables
Monitors progress of sites/ CROs/ vendors against requirements and leads discussion of current status and resolution of issues
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 Neuroscience indications 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 6737.
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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