Tel: +44(0) 20 8560 2300
Resourcing Solutions for Medical Affairs, Regulatory Affairs and Clinical Development
AX 5071 Manager Clinical Operations and Compliance, SOCS CFU
Apply NowJOB SUMMARY:
Our client is a top tier pharmaceutical organisation based in Hertfordshire. This is a unique role which will combine your knowledge of Clinical Operations, Drug Safety and implementing and managing process. You have strong leadership capabilities with the ability to provide direction for these processes through direct line management of the clinical operations CFU staff. You will have extensive experience working
BACKGROUND:
Top Tier Pharmaceutical company based in Hertfordshire
PRIMARY DUTIES:
• Primary responsibilities include management of the staff and processes established for the management and distribution of Serious Unexpected Safety Alert (SUSARS) as well as coordination and maintenance of Trial Master Files (TMFs).
• Manage objectives and provide mentoring for UK Clinical Operations CFU staff.
• Plan and identify resources for UK based Clinical Operations CFU initiatives, as needed
• The Manager will on a routine basis evaluate the effectiveness of the existing processes and in conjunction with departmental objectives, create solutions that will decrease or eliminate duplication of efforts or inefficient processes. The manager will escalate and identify processes/issues and inform or request appropriate intervention by the Associate Director, Clinical Operations in a proactive manner. The Manager will also collaborate with IT to address any technical/database related issues.
• Measure of success would include a positive impact on clinical trial timelines and/or controlled document, training, TMF or SUSAR issues. In addition, establishing innovative methods to streamline or combine activities which facilitate the quality of study trial documentation
QUALIFICATIONS / EXPERIENCE REQUIRED:
A bachelors in Science or health related discipline.
KEYWORDS:
Study Trial Administrator, CRA, SCRA, Senior CRA, Drug Safety, Clinical Operations Compliance
TO APPLY:
For a confidential discussion please telephone at AXESS Limited on 020 8560 2300 or, click on “apply now” below, to submit your details
Only candidates with EU work authorisation will be considered.
ABOUT AXESS:
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