Senior Clinical Data Manager

Here is a new and exciting Senior Clinical Data Manager job at a pharmaceutical company that specialises in biomaterials for the regeneration of bone, cartilage and tissue. This vacancy is based at their site in Maidenhead.

Job Responsibilities

• Contribute to data management activities as a lead study data manager in support of Alnylam clinical studies
• Lead database build activities including leading cross-functional review of eCRF content, review of edit check specifications, and perform user acceptance testing
• Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews * Oversight of database lock activities and ultimate archiving of study data
• Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, and Regulatory Affairs; CROs, central and local laboratories, and other vendors
• Establish cross-functional, internal data review plans, coordinate data cuts/transfers, and conduct data reviews
• Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation
• Contribute to development and implementation of department workflows and infrastructure strategy (such as preferred provider interactions, SOPs, and templates) that reflects data collection standards, consistent with industry best practice and regulation
• Represent data management and effectively communicate requirements, strategy, timelines and deliverables at internal cross-functional team meetings and meetings with external vendors

Skills and Requirements

• BS/BA in scientific discipline,
• At least 7 years related experience in a pharmaceutical/biologics/biotechnology company
• Experience working in clinical drug development through Phase 3 in an outsourced CRO model; experience with drug development in rare genetic diseases preferred
• Expert knowledge of eClinical processes, efficient design/build of an EDC data management system and other Clinical Trial/Data Management Systems
• Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
  

To Apply

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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