Position: Principal Clinical Data Manager (PCDM) Employment Type: Contract [No h1b/sponsorship available] Location: Remote - anywhere from within USA, PST Time zone Summary: Elan Solutions, a staffing agency supporting one of our premier clients - A Clinical Research Organization (CRO), is seeking a highly experienced and detail-oriented Principal Clinical Data Manager (PCDM). This role entails overseeing the start-up and execution of multiple clinical trials, ensuring data quality and compliance with regulatory standards. The PCDM will manage complex studies, overseeing Data Management processes, budgeting, project timelines, and client interactions. Responsibilities: Lead and manage all Data Management activities, ensuring quality, accuracy, and adherence to timelines. Develop and refine Data Management processes, providing expertise to project teams, clients, and CROs. Act as the primary escalation point for data management issues. Ensure compliance with SOPs, study plans, and regulatory requirements. Oversee and perform tasks such as database builds, User Acceptance Testing (UAT), and data cleaning activities. Draft, review, and approve essential Data Management documentation (e.g., Data Management Plan, eCRF/Database Specifications). Conduct data reconciliation, collaborating with external vendors as necessary. Monitor and manage study budgets, handling forecasting, scope assessments, and change order processes. Lead governance calls with clients and vendors, supporting project success and client satisfaction. Supervise team members, providing feedback and training. Qualifications: Experience: Minimum 15 years of Data Management experience with at least 5+ years in a CRO. Education: Bachelor's degree (B.S./B.A.) in a science or technical discipline. Technical Skills: Proficient in MS Excel; knowledge of SQL or SAS is beneficial. Knowledge: Strong understanding of FDA, EMA, ICH guidelines, and GCPs related to clinical data management. Communication: Excellent verbal and written skills; strong client and team interaction abilities. Travel: Willingness to travel for client or team meetings if required. Additional Skills: Strong attention to detail, prioritization, and time management skills; experience with budgeting and scope management.