Senior Manager, Clinical Data Management

Role and Responsibilities: Provide oversight to CRO clinical data management (CDM) activities for assigned studies. Review and provide feedback on CDM and study documents, including the Data Management Plan, study protocols, data transfer agreements, and data validation specifications. Ensure case report forms (CRFs) are designed and developed according to the study protocol and supporting documentation. Oversee the electronic data capture (EDC) database build process, including review of specifications, data validation documents, and user acceptance testing (UAT) during initial build and subsequent modifications. Perform detailed data reviews of clinical trial data when necessary. Represent the CDM team at cross-functional and clinical study meetings. Ensure timely delivery of milestones and manage CRO activities accordingly. Communicate trial status, milestones, and deliverables throughout the study duration. Collaborate with Programming, Biostatistics, Clinical Operations, Patient Safety, Pharmacovigilance, Medical Science, and other teams to meet project timelines. Support external vendor selection processes as needed. Contribute to departmental improvement initiatives. Serve as the primary contact for partners and subcontractors regarding data management activities. Provide data management and technical expertise, working with CRO data managers and decision-makers. Supervise clinical data management activities, including negotiations with CROs on timelines, processes, and quality issues. Identify requirements for clinical database development and amendments in collaboration with the trial team. Validate or perform sponsor User Acceptance Testing of clinical databases. Support sponsor medical review of clinical data. Escalate unresolved issues and work with relevant teams for resolution. Participate in the development and implementation of new technologies or tools. Participate in CRO selection processes, including proposal reviews and bid defenses. Review and support scope of work, contracts, budgets, and invoices related to data management. Contribute to the development and maintenance of standard operating procedures and templates. Assist the Quality Assurance team with audits involving data management activities. Experience, Education, and Skills: Bachelor's degree in Life Sciences, Computer Science, or a related field, or equivalent experience. At least 8 years of clinical data management experience in biotech or pharma, with a strong understanding of late-phase drug development, preferably in Phase 3 Oncology trials. Leadership and supervisory experience in managing CDM staff, demonstrating strong leadership skills. Attention to detail, strong communication skills, and accountability. Experience overseeing CRO and vendors is preferred. Knowledge of clinical research regulations, including FDA, ICH, GCP, and GCDMP. Proficiency in Microsoft Office Suite (Outlook, Word, Excel, etc.).

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