Manager, Clinical Data Management

Accountabilities: The Manager, Clinical Data Management will oversee end-to-end data management activities, ensuring clinical trial data is accurate, complete, and delivered according to timelines and quality standards. This role requires close collaboration with internal teams, CRO partners, and third-party vendors to maintain effective data processes and support clinical program success. Serve as the clinical data management functional lead in study team meetings, ensuring effective communication, collaboration, and overall data quality. Own study-level data management deliverables, including timelines, quality oversight, adherence to procedures, and operational execution. Coordinate data reconciliation activities, including vendor transfers, safety data reconciliation, and issue resolution across functional teams. Investigate and resolve data issues identified through statistical, safety, clinical, and medical reviews. Partner with CROs and vendors to develop, test, implement, and maintain electronic data capture tools and study databases. Manage post-production database modifications while ensuring consistency, communication, and controlled implementation. Develop, maintain, review, approve, and archive key data management documentation, including data management plans, edit check specifications, CRF guidelines, and review plans. Oversee data review processes, patient profiles, data cleaning activities, database lock procedures, close-out audits, and archival activities. Manage clinical data transfers from external vendors and ensure appropriate handling of study information. Support continuous improvement of clinical data management processes and operational practices. Requirements: The ideal candidate brings hands-on clinical data management experience, strong organizational abilities, and the capacity to manage multiple priorities in a regulated healthcare environment. They should demonstrate technical knowledge of clinical data standards, excellent communication skills, and the ability to work independently while collaborating with diverse stakeholders. Bachelor’s degree required, with 4–6 years of industry experience in clinical data management or a related field. Experience managing clinical study data deliverables from startup activities through database lock. Strong understanding of global clinical data management standards, processes, and best practices. Experience working with CROs, vendors, and cross-functional clinical teams. Demonstrated ability to manage competing priorities, meet strict deadlines, and adapt to changing requirements. Strong project management skills with excellent organization and attention to detail. Ability to review and resolve complex data issues with sound judgment and independent decision-making. Proficiency with Microsoft Office tools and web-based applications. Excellent written and verbal communication skills, including documentation and reporting abilities. Ability to establish effective working relationships with colleagues, managers, and external partners. Understanding of operational metrics, productivity initiatives, and quality improvement practices. Benefits: Competitive compensation package. Remote work flexibility. Opportunity to contribute to impactful clinical programs within a growing healthcare organization. Collaborative environment with cross-functional teams and external partners. Professional growth opportunities within clinical data management and operations. Benefits package designed to support employee well-being and career development.