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HEALTH
YOURSELF
WEALTH
Job Description
The Clinical Data Manager is responsible for delivery of an entire clinical trial. Is sponsor facing and works with study project management and technical data management team to meet the design specs, monitor the health of the trial, ensure quality and data reconciliation.
Ensures clinical trial databases meet project requirements by:
- Attending and participating in sponsor meetings
- Managing all data management deliverables for assigned studies
- Ensures the plan for data management is properly executed by:
- Understanding the requirements for study implementation and data collection
- Collaborating with project team to develop study-specific edit check criteria
- Defining, running, and reviewing edit checks and resolving discrepant data
- Maintaining organized, complete, and up-to-date study documentation
- Performing study setup, specifications, and obtaining approvals as needed
- Coordinating and documenting the receipt and processing of electronic or ancillary data received from outside sources (e.g., data received from other central laboratories, CRO's, or Sponsors).
- Keeping supervisor informed of project status
- Ensures the accuracy and consistency of clinical databases by:
- Reviewing data and identifying errors/inconsistencies
- Collaborating with appropriate project team to resolve data issues
- Tracking outstanding issues and following-up until resolution
- Ensuring accuracy in manipulation and scrutiny of clinical data and that CDM activities are carried out according to regulatory guidelines
Qualifications
- Minimum 1 - 2 years experience in comparable position within the pharmaceutical, biotech or CRO industry recommended
- Working knowledge of relational database organization and validation
- Familiarity with SAS desirable
- Experience working with office productivity tools including Word, Excel and Access preferred
- Understanding of clinical trial terminology desirable
- Proven ability in problem solving
Education
- Bachelor degree in Computer Science, Life Sciences or related field preferred, or equivalent experience required
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