Please note that this is a 1 year position.
CONTRACT CLINICAL DATA MANAGER - Qualifications • 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.
CONTRACT CLINICAL DATA MANAGER - Under supervision of the Manager of Data Management, plans and executes clinical database activities of varying complexity in support of FDA 510k, PMA and BLA submissions, and international registrations. Core Responsibilities • 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.
Please refer to job reference number 2842.