Worldwide Clinical Trials is a global, midsize contract research organization (CRO) focused on delivering high‑quality clinical research services. About the Role The Senior Clinical Data Manager will lead and manage data management activities across multiple complex global clinical trials, ensuring efficient, accurate, and timely delivery to sponsor satisfaction. Responsibilities Provide autonomous leadership of data management services (start‑up, conduct, close‑out) across multiple complex global projects/programs. Ensure appropriate resources are allocated to complete all data‑management activities on time and within budget. Prepare data‑management trial documentation, including the Data Management Plan (DMP), database specifications, edit check specifications, clinical‑control guidelines (CCGs), and database to analytical file (DTA) specifications. Ensure effective user acceptance testing (UAT) is performed. Write external vendor reconciliation specifications for programming reconciliation outputs (e.g., Serious Adverse Events, Interactive Response Technology, Central Laboratory). Oversee data cleaning activities and produce metrics to monitor progress of trial activities. Ensure all database lock activities are completed on time. Represent Worldwide DM at internal and external study meetings, providing input when required. Monitor project scope, budgets, and risks; alert DM Management of any concerns. Liaise with DM Management at project review meetings to discuss progress and outstanding issues. Collaborate with internal Worldwide departments working on the same project. Provide feedback on process improvements to DM Management and/or SMEs. Participate in and lead process reviews. Provide training, support, and mentorship to other members of the DM department. Participate as necessary in sponsor audits, regulatory authority inspections, and other third‑party meetings. Perform other duties as assigned. Qualifications Minimum of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries. Bachelor’s degree or higher in biomedical sciences, life sciences, computer science, or a related discipline – or equivalent relevant experience. Excellent attention to detail. Excellent written and verbal communication skills. Strong knowledge of data management best practices and technologies applied to clinical trials. Excellent communication and interpersonal skills with cross‑functional internal and external teams. Strong understanding of clinical trial processes and protocol documents (protocols, statistical analysis plans, CRFs, study reports). Strong analytical and problem‑solving skills. Independent and autonomous project oversight skills. Ability to work independently without automatic promotion to the next level based on years of experience; staff are evaluated on competency, responsibility level, and independence. Benefits & Compensation Annual salary range: $79,000.00 – $157,000.00 U.S. The final salary will be determined based on experience, performance, education, and internal equity. In addition to base salary, a competitive benefits package is offered based on location. We are an equal‑opportunity employer committed to fostering an inclusive and equitable workplace. Pay equity and transparency are ensured, and we comply with all applicable labor laws. #J-18808-Ljbffr
Senior Clinical Data Manager • Raleigh, NC, United States
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