Clinical Data Manager

The position is responsible for the oversight, coordination, and execution of clinical data management activities across one or more clinical trials. Provides broad expertise within clinical data management and related disciplines, leading the design, oversight, and execution of clinical data strategies that support high-quality, regulatory-compliant data deliverables. Key Responsibilities: Lead Clinical Data Management tasks for a project, including eCRFs, eCRF completion guidelines, Data Management Plan (DMP), and other CDM documents. Oversee implementation of project-specific Clinical Data Management systems and/or processes. Oversee data processing plans within established timelines and budget; adjust as needed. Lead clinical data management activities from study start-up through database lock. Design, review, and finalize case report forms (CRFs). Develop and maintain data management plans, data review guidelines, and edit check specifications. Oversee database development, validation, user acceptance testing, and go-live. Monitor data flow to ensure timely and quality data availability for analysis. Ensure compliance with SOPs, GCP, and applicable regulatory requirements. Review and contribute to clinical protocols and statistical analysis plans. Manage external vendors/CROs/partners for outsourced data management tasks. Represent data management in cross-functional meetings; communicate status, risks, and resolutions. Provide analysis and feedback on CDM tasks, systems, or processes. Contribute to improving data management processes and tools. Monitor/manage study budgets; assess change orders. Train and mentor junior team members. Participate in audits/inspections; support corrective and preventive actions. Communicate with departments as needed; perform other duties as assigned. Desired Experience/Education and Personal Attributes: Bachelor’s degree in related scientific discipline. Minimum 10 years related industry experience. Strong understanding of CDISC (CDASH, SDTM), ICH-GCP, FDA, and other regulatory guidelines. Expert knowledge of EDC systems (e.g., Medidata Rave, Veeva). Experience with database design, development, and user acceptance testing. Expert knowledge of clinical trial processes, data flow, and data cleaning. Excellent problem-solving; strong leadership and communication. Experience with CROs/vendors/global clinical teams; led data management for global trials (sponsor or CRO). Strong organization, prioritization, critical thinking, and project management; ability to handle multiple projects in a team environment. #J-18808-Ljbffr