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Clinical Data Management Analyst
Ref No.: 18-02823
Location: Raritan, New Jersey
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:401K, Dental Insurance, Medical Insurance
*12+ month contract position*

Overview:
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.
·         Design and build eCRFs in Medidata Rave including database validation checks.
·         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.
 
 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 SAS is required.
·         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 Rave and ability to conduct study builds 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.

Pay Rate: $44 to $48 per hour
Drug and background screenings required


On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.