Lead Clinical Data Manager
CurrentAccountable for clinical data management start-up, conduct, closure, and reporting activities.Collaborated with Biometrics Vendor partner and the Clinical Team for successful data management milestones.Planned, coordinated, and ensured timely delivery of complete, high-quality clinical trial data.Conducted oversight of data management activities by CROs and 3rd party vendors to meet Repare's obligations.Oversaw data transfer agreements with external vendors, ensuring reconciliation alignment with study goals, and served as the main contact for CRO and external vendors from protocol development to database release.Planned, performed, and oversaw the development of specifications for eCRFs, edit checks, and electronic data handling.Represented data management on cross-functional teams, providing accurate study status updates and proactive communication.Reviewed and provided input for all DM documentation and clinical documentation.Collaborated with CRO to implement data cleaning tools for EDC, IRT, SAE, and external data.Led end-to-end delivery of data management services, ensuring on-time and high-quality deliverables.Conducted cross-functional data reviews, providing support and tools for successful outcomes.Managed clinical trial data through review, cleaning, auditing, and validation procedures for regulatory compliance.Led in implementing CDM services and productivity improvements, utilizing metrics for optimization.Co-chaired CDM review meetings, ensuring projects align with high-quality standards, timelines, and company goals.Ensured inspection readiness of all Data Management Trial Master File (TMF) documents.Developed plans for operational challenges and contributed to SOPs and TOOLs related to Clinical Data Management.Contributed to preparing RFPs and RFIs for new studies in a fast-paced, innovative environment.
