Clinical Data Manager - Homebased
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An exciting job vacancy has emerged for a Clinical Data Manager to join one of the world's largest global CROs. This contract research organisation provides support services to many of the biggest names in pharmaceuticals, biotech, medical devices and health care, and has helped to commercialise many leading therapies. This position will be based at their UK site in Reading.
Job Responsibilities:
- Ensures the timely initiation, conduct, and completion of Data Management activities on clinical trials.
- Leads a sub-team of Data Management staff members assigned to a project.
- Tracks Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverables.
- Authors the Data Transfer Agreement (DTA) with third party external data vendors
- Oversees UAT of clinical data systems (EDC, eCOA, IWRS) to be implemented on a project.
- Conducts project-specific training throughout the course of the project, as needed.
- Attends and presents at client bid defense meetings.
- Attends and presents at project meetings as required.
- Oversees the completion of a comprehensive data review of clinical data.
- Ensures medical coding is performed in a timely manner
- Ensures DM documentation is audit-ready and filed appropriately at all times.
- Coordinates all activities in preparation for database lock, including Data Review Meeting.
- Produces status or progress reports, listings, and other output as required during the course of the project
- Monitors budget and scope of work for contracted DM services throughout the duration of the project, identifying out of scope or budget activities, and collaborating with the project manager when out of scope documentation and costs are needed.
Skills and Requirements:
- Bachelor's degree in a related field of study or equivalent combination of education and work experience
- Minimum 2 years' experience in clinical research
- Demonstrated experience in a lead role
To Apply:
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 Sam Walker on +44 203 8569 336 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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