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Senior Clinical Data Manager

Job Summary

Responsible for conducting and overseeing Clinical Data Management (CDM) activities of assigned clinical studies, in accordance with agreed-upon timelines and in compliance with regulatory requirements and quality standards as per industry best practice. Responsible for ensuring that all CDM activities for assigned studies conducted within or on behalf of WCCTG (whether internal or external) are continuously aligned with corporate needs, and are performed according to corporate SOPs. Responsibilities include but are not limited to database build, data review, eCRF development for assigned studies, development of standard validation checks and query language, etc. Responsible for ensuring data is of high integrity; Development/maintenance of the Data Management Plan (DMP), Data Validation Specifications (DVS), and other data management documentation as required. Additional responsibilities may include attending sponsor meetings and serving as backup to the Associate Director, Clinical Data Management on needed tasks, as assigned.

 

Essential Job Functions

  1. Act as a first point of contact for all data management deliverables for assigned studies.
  2. Perform study set up activities, as required.
  3. Review and provide input to all study specific documents.
  4. Provide input to the CRF layout as per protocol requirement.
  5. Provide input into Edit Specifications.
  6. Assist in the development of global libraries.
  7. Responsible for database review, testing and UAT of edit checks specifications for assigned studies.
  8. Coordinate development and validation of study database.
  9. Declare database go-live/ database lock.
  10. Responsible for monitoring study progress and timely locking of database.
  11. Accountable for all data management study deliverables from study initiation to database lock.
  12. Adhere to WCCTG and Sponsor SOPs/SWPs as required.
  13. Ensure audit readiness of data.
  14. Manage relationships with internal and external customers at both the operations level and with functional peers.
  15. Ensure data management milestones are met per agreed upon timelines with high quality.
  16. Coordinate and work closely Project Manager to ensure that study deliverables are met as per the timelines and with high quality.
  17. Participate in Study Kick Off meetings and Study Team meetings for the assigned studies.
  18. Manage vendors as needed for assigned studies.
  19. Provide accurate reports on assigned projects.
  20. Effectively communicate relevant project information to management.
  21. Resolve and/or escalates issues in a timely fashion.
  22. Attend client meetings as needed.

 

Qualifications

Education

  • Minimum of a Bachelor’s degree or higher in Life Science or related field

Experience/Training

  • Minimum of 4 years of industry experience leading studies in a Data Management
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