Remote Clinical Data Manager | CRF Design & Data Integrity

EDETEK

United States

Remote

USD 70,000 - 95,000

Full time

11 days ago
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Benefits offered by this job

Medical, Vision and Dental Insurance
Paid vacation and sick days
Corporate holidays
Participation in the 401K Plan
Perks and discount programs
Health Advocate and Employee Support

Job summary

EDETEK is seeking a Clinical Data Manager to lead data management activities, design CRFs, and ensure data integrity in a remote, US/South America capable role. You will manage SDLC tasks, coordinate with CDSs and sponsors, and oversee testing, data transfers, and documentation to deliver high-quality clinical data.

Ideal candidates have at least 2 years in clinical data management, knowledge of EDC systems and SAS, and the ability to manage multiple priorities in a dynamic setting.

Qualifications

  • A Bachelor's degree or equivalent combination of Education/Training/Experience is required; science/medical/tech preferred.
  • Minimum 2 years of clinical trial or clinical data management experience.
  • Working knowledge of EDC studies and SAS is required.
  • Prior trial responsibility for the entire data management life-cycle desirable.

Responsibilities

  • Support Internal Clinical Data Management Initiatives.
  • Complete Traditional and Assigned Data Management Operations/Activities.
  • Contribute to Project Success by Conducting Duties per CPM/LSCDM Request.
  • Design Case Report Forms (CRFs).
  • Assist in Development and Maintenance of Systems Used to Support Project Infrastructure.
  • Work with Clinical Data Specialists (CDSs) to Execute Data Management Plans.
  • Work with Clients/Sponsors as Necessary to Deliver Contracted Clinical Data Management Services and Clinical Data with High Quality and Integrity.
  • Code Data per Selected Coding Dictionaries.
  • Clean Data.
  • Develop / Execute Testing Strategies.
  • Assist with Data Transfers, Loading and Integration.
  • Complete All Required Documentation per EDETEK and Project Requirements.
  • Perform Use Acceptance Testing (UAT) on New Software.
  • Classify Clinical Events per Agreed-upon Strategies/Plans Classification.

Skills

Communication in English
Lead functional meetings
Detail orientation
Organizational skills
Multi-project management
Team collaboration
Independent work
Adaptability to change
Prioritization under pressure
MS Office proficiency
Project management software

Education

Bachelor's degree or equivalent in scientific/medical/technological discipline

Tools

MS Office
Project management software
SAS
EDC familiarity

Job description

EDETEK is seeking a Clinical Data Manager to lead data management activities, design CRFs, and ensure data integrity in a remote, US/South America capable role. You will manage SDLC tasks, coordinate with CDSs and sponsors, and oversee testing, data transfers, and documentation to deliver high-quality clinical data.

Ideal candidates have at least 2 years in clinical data management, knowledge of EDC systems and SAS, and the ability to manage multiple priorities in a dynamic setting.

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