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Data Manager

The CDM is responsible for all clinical data management aspects for the assigned global clinical studies from preparation until archiving. The study responsibilities include:

  • Responsible for leading, guiding and overseeing the CROs data management activities and responsible for overseeing vendors involved in the assigned clinical studies based upon metrics and plan
  • Assisting in CRO contract negotiations together with the company’s clinical study manager and Director Vendor Management
  • Providing input into and/or developing study related materials such as Clinical Study Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF/EDC and Edit Check Specifications, eCRF completion guidelines, External Data Reconciliation Plans, SAS Listing Specifications, Lab Data Transfer Plans, etc.
  • Overseeing and tracking patient data entry and query resolution following agreed timelines
  • Ensuring clinical studies are conducted in compliance with ICH-GCP and other applicable legislations related to Data Management activities
  • Reviewing protocol deviations and related data listings for studies to ensure that high quality data are delivered and identifies and solves structural issues/concerns
  • Performing QA/QC checks of the data recorded in the clinical database in line with the company’s quality standards
  • Ensuring timely collection of CRF documentation for periodic Medical Review and IDMC/DSMB Review
  • Pro-actively identifying and solving issues in the assigned clinical studies and timely escalating them to the Clinical Study Manager, Project Manager, Head of Clinical Operations or Senior Management, if needed
  • Assisting the Clinical Study Manager in the preparing of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan and quality in line with the company’s quality standards for Data Management related activities
  • Communicating in a transparent, clear way and motivating team members to work towards achieving clinical study goals

 

The CDM will also participate in activities other than study-related which included but are not limited to:

  • Co-writing/maintaining SOPs within the Clinical Operations department related to Data Management
  • Staying up to date with applicable industry standards related to Data Management (ie CDISC, SDTM, …)

Data Management, SAS, Senior management, Clinical Research, Accurate Data Entry, Biology, CDISC, Oncological care, Protocols, Biomedicine, Clinical Monitoring, SOP, Data Transfer, Query Resolution, Data Quality, Management, Budget, Coaching, Archive, CDM, Quality Control, Quality assurance, Database, SDTM, Metric, CRO, Vendor Management, CRF, EDC, Legislation, Clinical Operations, Mathematics, Management plans, Veterinary, Clinical, Pharmacy, Vendors

Data Manager

FERN VALLEY, Ghent
Categories: 
R&D, IT, Quality / Security / Environment, Project Manager, Developer, Data Manager
Career level: 
Manager
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