Clinical Data Manager

Location: Summit, New Jersey, United States
Salary: competitive
Job Type: Contract
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Title: Clinical Data Manager

Duration: 6 Months to Perm

Location: Home Based- Remote

Hours expected: 40 hours per week

Day to Day Duties/Responsibilities/ Scope of Work:

  • Technical leader for start-up, maintenance, and completion activities and develop [Global] Data Management Plans and Quality Management (QM) Plan.
  • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
  • Coordinate the development and testing of data management systems edit data validation checks) diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities.
  • Review data acquisition conventions and data review guidelines, diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion.

Qualifications/Requirements:

  • Minimum five (5) years relevant work experience in data management with approximately one (1) year technical supervisory experience to include data management, clinical operations, and knowledge of several therapeutic areas.
  • Demonstrated skill for technical management of staff exceeding 5 employees.
  • Excellent oral and written communication and presentation skills.
  • In depth knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
  • Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnological companies.
  • Ability to lead by example teams on project strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
  • Demonstrated managerial and interpersonal skills.

Sthree US is acting as an Employment Business in relation to this vacancy.

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