Posted 6 months ago  

Clinical Data Manager

Posted 6 months ago - 66 views - 11 Applied

The Clinical Data Manager provides data management support to ProPharma Group clients. 

Essential Functions Include:

  • Complete Data Management tasks for assigned studies under supervision according to the study contract and applicable SOPs and under direction from the data manager leading the study.
  • Operate under the study-specific documentation, including, but not limited to: Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures.
  • Create test data for User Acceptance Testing (UAT).
  • Perform and document database UAT.
  • Reconciliation of electronic data.
  • Perform data review via listings and EDC system and issue queries as needed.
  • Manage queries to ensure data completeness and integrity.
  • Perform SAE reconciliation.
  • Perform pre-lock and data lock tasks.
  • Participate in client and team meetings as required.
  • Design, generate, and review status metric reports as needed.
  • Perform archiving of study databases and related documents
  • Provide input to timelines to ensure timely completion of assigned tasks.
  • Provide regular status updates and keep the team and management informed of any changes.
  • Organize and file study documentation.

Qualifications

Qualified candidates must have:

  • Minimum BS in a scientific or health related field or the equivalent in years of experience
  • Minimum 3 years of experience in Clinical Data Management.
  • Expertise with EDC systems, such as Medidata Rave, InForm, IBM Clinical, Veeva EDC or Medrio
  • Excellent communication and time management skills.

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Before you apply, please check if any restrictions apply in terms of time zone or country.

This job has a geo-restriction in place:USA Only.