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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