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Clinical Data Manager I - Oferta z Jobs.pl

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Clinical Data Manager I

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  • Anetta Kotynska is currently recruiting for an experienced Clinical Data Manager to join a leading global drug development company based in Warsaw on a permanent basis.Main duties and responsibilities will include:Within this role, you will serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities. This will include:• Developing [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data • Identifying and implementing solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts • Serving as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics • Coordinating and participating in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications • Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions • Coordinate the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality Some of the key requirements for this position:• You will need to hold a University/college degree (life science, pharmacy or related subject preferred)• A high degree of demonstrable relevant work experience in data management including working knowledge of the technical supervision / matrix management of team members to include data management, clinical operations, and knowledge of several therapeutic areas. • Ideally demonstrated skill for technical management of staff exceeding 5 employees• Financial management of gross revenues in excess of $250K per year • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations A more detailed job spec is available on requestCK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL37053 in all correspondence.


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