Clinical Study Management Associate (Contract)
ProClinical is seeking a Clinical Study Manager Associate on behalf of a leading oncology pharma. This is a rolling contract role with flexible working based in Cambridge.
- Assist in managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA/EMA regulations and ICH/GCP guidelines.
- Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.
- Assist with the development and review of informed consent forms, case report forms, study manuals, and other supporting clinical trial materials.
- Assist with evaluating, selecting, and managing clinical study sites.
- Assist in the evaluation, oversight and management of CROs and other vendors and systems.
- Assist with negotiation and co-management of contracts/budgets with CROs and other vendors.
- Provide input to and co-manage project objectives to meet timelines and deliverables.
- Responsible for tracking/maintaining study metrics/progress and providing routine study updates via the Clinical Operations Manager, to the project team/sub-team.
- Assist with the analysis and development of action plans to address issues with investigational sites and/or CROs.
- Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality.
- Assist in training/mentoring new team members on specific study processes, as required/appropriate.
- Serve as a primary contact for Investigator sites.
- Review and provide input to regulatory documents (Clinical Trial Application documents/CEC application documents/ IRAS/R&D forms).
- Participate in the analysis and reporting of safety issues, patient care issues, and study design and/or study conduct issues.
- Review and negotiate clinical site study contracts and budgets.
- Assist with the planning, coordination and presentations at Investigator Meetings and CRA Training meetings as requested.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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