Clinical Data Manager

Clinical data, management experience, SMP/FDA, Code, CRA/eCRF development, SAS preferred
Contract W2, 1 year
Negotiable
Telecommuting not available Travel not required

Job Description

Please note that this is a 1 year contract position.

  • Coordinate and ensure the timely completion of all Data Management activities for assigned projects following appropriate regulatory guidelines, and company and department SOPs.
  • Provide technical and Data Management expertise as a member of a cross-functional project team.
  • Write clinical Data Management Plans and associated documents (i.e., database specifications, data entry guidelines) and drive the project team review and approval process.
  • Facilitate clinical trial eCRF development or other data capture processes.
  • Oversee and/or conduct and document the User Acceptance Testing of data entry screens, database build and edit check programming.
  • Process and manage instrument generated data including edit checks using SAS.
  • Perform data review activities and interact with clinical sites or the responsible CRA to coordinate error resolution using Data Clarification Forms and deviation documents.
  • Special projects as assigned
  • A higher degree (Bachelor's degree, etc.) in a computer science/technical/scientific field with a minimum of 5 years of Clinical Data Management experience is required.
  • Training in GCP, GMP and pertinent sections of FDA Code of Federal Regulations (e.g. CFR 21 part 11) is required.
  • Knowledge of SAS is Preferred.
  • Familiarity with clinical trial protocols, analysis plans, analysis requirements documents, company and departmental SOP’s required.
  • Knowledge and demonstrated skills using PageMaker or InDesign is highly desired.
  • Knowledge of Medidata is required.
  • Project management skills as evidenced by the ability to function as a member of a cross-functional project team is preferred.
  • Knowledge of maintenance Trial Master File (TMF) and Site Regulatory file. Collects, verifies acceptability and distributes all Investigative site regulatory documentation to Regulatory Affairs as appropriate.
  • Prior experience in the diagnostics industry is preferred

For consideration, please reference job numer 2726

 

Posted By

San Francisco, CA

Contact
Dice Id : NETSO
Position Id : 2726
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