Senior Clinical Data Manager job in London, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: VP/Head of Clinical Operations

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

An exciting opportunity has arisen for a talented Senior Clinical Data Manager in the UK. In this role you will be expected to lead and contribute to data management activities across all stages of clinical drug development.

Job Responsibilities

Contribute to data management activities as a lead study data manager in support of 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 Participate in the training of external vendors and site staff
Participate in the drafting and/or review of timelines consistent with company goals and ensure all deliverables and milestones are met
Review clinical protocols/amendments, clinical study reports, statistical analysis plans, etc.
Support GCP inspection readiness

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
Knowledge and understanding of regulations and industry/adopted data standards such as CDISC, SDTM, and CDASH
Experience working with Oracle InForm and Medidata Rave
Experience using standardized medical terminology, including MedDRA and WHODrug Experience working with MSOffice Suite (Excel, Word, PowerPoint) and familiarity with MS Project
Excellent written and oral communications skills
Highly motivated and flexible, with excellent organizational and time management skills
Ability to work independently and as part of a multi-disciplinary team
Understanding of ICH GCP as well as general knowledge of industry practices and standards

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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