Remote The organization seeks a Clinical Data Manager to lead data management activities for a cardiovascular clinical trial. The role will oversee CRO partners, EDC build and validation, external data processing, coding oversight, data review, and database lock in accordance with GCP and ICH. The position will focus on timeline adherence and data quality across study start‑up through closeout. This is a 1‑year contract with potential extension and will operate remotely with optional hybrid access near Princeton, NJ or San Francisco, CA. Rate: $50‑60/hr (w2). W2 consultants receive a benefits package that includes medical, dental, vision, 401(k) with matching, and life insurance. Responsibilities Lead clinical data management for an assigned cardiovascular trial in alignment with SOPs, GCP, and ICH guidelines. Conduct protocol review and develop or review database definition files for CRFs/eCRFs, Data Validation Plans, and Edit Check Specifications. Perform or oversee user acceptance testing of eCRFs and edit checks for databases under development. Manage database change requests after go‑live. Review CRF/eCRF for outsourced trials and generate queries as needed. Review edit check specifications, Data Management Plans, and study‑specific Manual Review Guidelines for outsourced trials. Oversee Data Transfer Agreements with ancillary vendors. Review and ensure query resolution for outsourced trials, including SAE reconciliation. Review data listings and manage cross‑functional reviews to identify safety signals and support regulatory reporting. Provide Data Management summary reports and ad hoc data reports to stakeholders. Ensure database close and lock at trial end. Resolve complex data issues to support interim analyses and timely decision‑making. Experience Requirements At least 5 years of clinical data management experience at the manager level. Sponsor‑side oversight experience of CRO data management activities for Phase III studies. Cardiovascular study experience (preferred). #J-18808-Ljbffr Eliassen Group
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