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 number 2726