Manager, Clinical Data Management

New
E
EDETEKClinical data management
This is a remote position, and we are open to candidates based in the United States.Full-TimeManager
Salary not disclosed
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Job Details

Languages
Ability to communicate effectively in the English language in person, by phone and in writing.
Experience
A minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training is required.
Required Skills
MS Office

Requirements

  • Hold a bachelor’s degree or have an equivalent combination of education, training, and experience.
  • A degree in a scientific, medical, or technological discipline is preferred.
  • Have at least 2 years of clinical trial or clinical data management experience, or similar industry experience or training.
  • Have working knowledge of EDC studies and SAS.
  • Prior responsibility for the entire data management lifecycle is desirable.
  • Understand Good Clinical Data Management service requirements and related documentation.
  • Understand relevant therapeutic indications, study hypotheses, and trial design.
  • Have a solid understanding of database design and structure.
  • Have advanced computer skills and practical knowledge of MS Office; project management software knowledge may be useful.
  • Be able to lead functional meetings, manage multiple projects, and prioritize and complete tasks to deadlines.
  • Travel may be required (5%), potentially over weekends.

Responsibilities

  • Lead clinical data management projects to support quality, timely delivery, and client satisfaction.
  • Complete traditional and assigned clinical data management operations and activities.
  • Communicate with clients about requirements and issues, monitor project progress and timelines, and enforce standard operating procedures.
  • Work with Clinical Data Specialists to execute Data Management Plans.
  • Lead client and sponsor communications to deliver contracted services and high-quality, high-integrity clinical data.
  • Support internal clinical data management initiatives and the development and maintenance of project infrastructure systems.
  • Write system design specifications, including for forms and reports, and facilitate testing of system implementations.
  • Lead user acceptance testing on new software.
  • Ensure required documentation is filed according to company and project requirements.
  • Select and interview clinical data manager candidates, and train and guide junior team members.
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