Clinical Data Management

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Location: Fremont, CA or Kolkata, India

If you have worked with several cross-functional teams, across geographic locations to manage clinical data, here is your next challenge.

Qualifications and Skills

  • Review documentation and requirements for new projects and anticipate impact to Data Management (DM) standards/processes.
  • Collaborate with client team for all requirement gathering of CRFs, edit checks, subject calendars, user management, reporting requirements etc.
  • Collaborate with internal project team (both onshore-offshore) as needed to stay abreast of and changes that could affect data collection, cleaning, change requests and/or transfers.
  • Develop Data Management Plan (DMP), maintain DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
  • Review Protocols, and develop Case Report Forms and study reports.
  • Develop trial database, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
  • Coordination of UAT of eCRF build and validation documents, included but not limited to: edit check document, issue logs, UAT summary report.
  • Manage eSource/EDC users and other Clinical databases, including but not limited to, compiling master user lists and activating/deactivating user accounts.
  • Perform user training both web-based and in-person at client locations, and create user guides.
  • Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.

Qualifications and Skills

  • Bachelor’s degree in Technology, Medicine, Science or related field.
  • At least five (5) years data management and/or related work experience in the pharmaceutical or CRO industry.
  • Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Working knowledge of Clinical database applications such as EDC and CTMS.
  • Excellent verbal and written skills, good organizational, interpersonal, and team skills.
  • Applicable knowledge working with other clinical databases such as Oracle Clinical, Medidata Rave, etc.
  • Experience with AE/SAE Coding, will be nice to have.
  • Experience with working on Phase I- IV study trials.
  • Ability to travel to site locations as needed (10-25%).