• EN

Clinical Data Manager

Boston Minimum 5 years Bachelor degree
  1. In charge of the study data management deliverables, such as eCRFs, Data Management Plan, Data Validation Plan, Study Risk Management Plan, Data Review Listings/Reports per company SOPs. Ensure that data management standards are followed. Participates in Investigator Meetings and other study meetings if required. Maintains knowledge of current regulations and technologies related to the data management function.
  2. Supports external data reconciliation, in addition to serious adverse event reconciliation.
  3. Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled.
  4. May work closely with database builders during clinical database build and programming of eCRF, edit checks, and reports.
  5. Participates in User Acceptance Testing (UAT) activities for clinical database build and modifications.
  6. Participates in UAT activities for data transfers and programmed report outputs.
  7. The primary data management contact person within clinical trial team for assigned study. Liaises directly with other functions to discuss the DM related work and timelines.
    1. Ensures clinical trial team are consulted appropriately on study decisions. Proposes solutions for data management issues that arise during the trial.
  8. Coordinates internal DM team for assigned study. Oversees the quality of data management activities for designated team members.
  9. Participates in the department activities. Implements and oversees the processes, coordinates activities in conjunction with the internal team and Team Leader. Continually evaluates DM processes and applications for improvements. Participates in working groups to develop and implement new procedures.
  10. For outsourced studies, manages external CROs independently on data management activities and maintains a good working relationship. Reviews vendor’s proposal and contract to ensure appropriate working scope, cost and agreed services. Assess vendor’s performance and risks.
Qualifications and experience:
  1. Bachelor degree or above in health/IT/math related field
  2. Minimum 5 years of experience including proven ability of leading data management activities
  3. Effective communication skills
  4. Understanding for ICH and regulatory environment as it pertains to data management
  5. Demonstrated basic knowledge of clinical trial database and its applications
  6. Demonstrated basic knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)
  7. Oncology experience preferred
  8. Medidata Rave experience preferred
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