Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an experienced individual to work as a Clinical Data Manager/Advisor at the National Institutes of Health in Rockville, MD. Please note option of 100% remote working arrangement is available.
This is a long-term contract position which offers: - Competitive compensation and comprehensive benefit package - Optional health, vision, and dental plans - Vacation leave as well as paid federal holidays and 401K plan. - Access to NIH’s unparalleled resources and niche scientific initiatives
TASKS/SERVICES. The contractor shall: (1) Oversee sponsor Clinical Data Management activities for the adaptive platform trial, ACTIV-2 for COVID-19 studies. (2) Work collaboratively across multiple cross functional groups including Clinical Trial Managers (CTMs), Biostatistics and Clinical Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines. (3) Provide technical oversight of service providers performing core data management functions including CRF/edit check development, user acceptance testing (UAT), integrated response technology (IRT), biostatistics, data cleaning, listings review, and database lock procedures. (4) Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates data management-related risks across functional areas of ACTIV-2 on behalf of the trial sponsor, Division of AIDS. (5) Conduct reviews of oversight related data, operations-related trend analyses, and performs report reviews. (6) Review the development of database specifications, validation plans, and data management plans, ensuring alignment with case report forms, protocol, and safety data standards. (7) Responsible for overseeing the end-to-end data management study related activities in terms of quality and delivery according to plan on a day to day basis. (8) Provide oversight for data management activities including: Implementation of data management aspects of ACTIV-2 and data collection systems; Strategic input into mitigation of potential data management issues; Review data management activities and recommend process improvements; Maintain high-level oversight on data quality metrics and data management deliverables.
REQUIREMENTS. The contractor must have: (1) Master’s Degree in related field (2) Minimum of ten (10) years of related experience including expertise/focus on clinical data management
PLEASE APPLY ONLINE When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position.
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