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Data Manager

OPR Associates Limited
Job LocationDiss
EducationNot Mentioned
Salary£35,000 - £40,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

A remote opportunity for a company based in Diss, Norfolk, UKThis is an opportunity with one of the worlds recognised specialist clinical biometrics CROs supporting global pharma, biotech, medical device and animal health partners with innovative, cost effective clinical development services.Overall PurposePerforms the Lead Data Manager role, delivering data management activities to contractual requirements, project scope and to agreed timelines according to the companys Standard Operating Procedures.

  • Prepare and participate in client and in-house audits and regulatory inspections
  • Promote satisfaction with the company Data Management services, foster sense of partnership and professional relationships across the company, sponsor and third party study teams
  • Provide back up support across the Data Management group as needed
  • Develop and maintain advanced knowledge and understanding of all relevant company systems and processes
  • Lead and contributes to the ongoing development and process improvement of the department and across the company; Act as a Subject Matter Expert if required
  • Lead and contribute to the development, maintenance and delivery of data management training as required
  • Mentor and support the development and progression of Data Associate IIs and Data Managers
  • Contribute to Business Development activities, participate in bid defence meetings as needed
  • Manage and plan own time effectively and efficiently, accurately determine and communicate study resource needs and make effective use of assigned data management resource
  • Accurately record time according to project-specific requirements and general company guidelines
  • Other activities as required by the Line Manager
    • Study Start up
  • Lead the development and finalisation of high quality data management documentation e.g. Data Management Plan, Data Validation Plan, Data Transfer Specifications, CRF Completion Guidelines
  • Contribute to the development, review and finalisation of the annotated eCRF
  • Lead and oversee the testing of the clinical database and validation checks including defining the testing plan, executing the tests and documenting the outcome. Liaises with the Clinical Database Programmer in the resolution of all issues
  • Define, communicate and lead the execution of the data management project plan
    • Study Management
  • As Lead Data Manager, perform, lead and coordinate all data review and query management activities per study documentation and the project plan to produce high quality clinical data deliverables
  • Through oversight and effective delegation, ensure data management activities on assigned studies are completed according within the scope of the study contract and manage progress against the study contract and project plan; Maintain accurate resource forecasts
  • Perform third party data reconciliation activities and work effectively with all third-party vendors
  • Perform SAE reconciliation and associated updates within agreed timelines, check for and follow up potentially unreported Serious Adverse Events (SAEs) on the clinical database
  • Maintain accurate, up to date data management documentation
  • Define and maintain data tracking and status information to enable accurate assessment and reporting of study status internally and with the sponsor
  • Lead and manage database upgrades
  • Maintain accurate paper and electronic filing systems to ensure safe and efficient storage of data and documentation
  • Maintain and takes responsibility for the execution of data management activities per the project plan
  • Lead and effectively contribute to study team meetings, internally and with sponsors and vendors
    • Required skills
  • Biometrics
  • Clinical Data
  • Clinical Development
  • Data Management

    • Keyskills :
    Biometrics Clinical Data Clinical Development Data Management

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