Clinical Study Manager - Biotech - UK
- Experience Level
- Experienced (non-manager)
Position: Clinical Study Manager
Position Type: Full time, permanent position
Location: Surrey / London area
Company: Small biotech
Following a recent recommendation, my team and are now partnered with an exciting growing biotech that are looking to bring on board a clinical study manager. This role will be reporting into the Head of Clinical Operations in the UK, in which you will be responsible for a number of different projects.
This is an exciting opportunity to work within a fast paced, busy environment in a leading, clinical-stage biotechnology business whose primary objective is the development of novel therapies targeting areas of significant unmet or poorly met medical need. Having successfully completed its FIH early phase clinical trials, the Company is now looking for a highly talented and motivated individual to support its Phase II programs.
The selected candidate will act as the functional lead from Clinical Operations with responsibility for delivery of all Clinical Operations aspects of clinical trials ensuring consistency with Company SOPs/Procedures, contracts, budgets and timelines.
- Operational site management of assigned clinical trials
- Ensuring major trial milestones are met
- Management/oversight of external service providers e.g. CROs, PV, data management etc
- Ensure high performance and efficiency of the CRO clinical team through the scheduling of co-monitoring /accompanied site visits Oversee IEC/IRB submissions and associated activities including collation of essential documents
- Track and manage budget and timelines
- Contribute to the production, review and update of key clinical documents eg clinical protocol/amendments, IBs, PIS-ICFs, trial plans etc
- Development and maintenance of SOPs in conjunction with QA
- Prepare monthly progress reports
- Set up and/or maintain trackers using Excel, software and any other reporting tools
- Ensure Trial Master File maintenance, compliance and review
- Attendance at site initiation, monitoring and close out visits, where required
- Support of Investigators, research coordinators and other site personnel.
- Perform adhoc tasks to support Clinical Operations activities
- Minimum of a Bachelor’s degree in life science, medical or related field
- 4+ years’ of clinical research experience gained with a CRO or pharmaceutical company working on Phase II to III clinical trials (including satisfactory progression of monitoring experience)
- Demonstrated ability to prioritise multiple projects
- Ability to work independently as well as part of a multidisciplinary team in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands
- Good understanding of ICH GCP and applicable local and national regulations for the conduct of clinical trials
- Fluent in written and spoken English
For more information, please reach out to me directly!
+44 1293 77 66 44
Barrington James is a uniquely successful specialist life science recruitment company and has recently been recognised as a BEST COMPANY To Work For by the Sunday Times. It has enjoyed an exceptional growth trajectory since its launch in 2002, and is now established in the heartlands of the international pharma, medical devices and healthcare industry with consultant staff already approaching 140, and planned to be 180 by the end of 2017.
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