Lead Clinical Data Manager

JOB SUMMARY

We are seeking a Lead Clinical Data Manager to serve as the primary Data Management resource on one or more clinical studies, directing activities from study start-up through database lock and close-out. This role provides project-level leadership across the full data management lifecycle, oversees CRO and EDC vendor performance, and represents Data Management on cross-functional study teams. The ideal candidate combines strong technical Data Management expertise with the ability to lead, mentor, and drive high-quality, on-time deliverables in a fast-paced environment.

KEY RESPONSIBILITIES

• Serve as the primary point of contact for Data Management activities on assigned studies, coordinating with sponsors, CROs, and cross-functional teams

• Manage clinical data activities across the full study lifecycle, from database setup and design through database lock and archival, including Database UAT, query management, and data cleaning activities, with third-party data reconciliation (e.g., SAE, labs, IRT/RTSM, ePRO)

• Author and maintain core Data Management study documentation, including the Data Management Plan (DMP), Data Review Plan (DRP), eCRF/CRF Completion Guidelines, Data Review Guidelines, Medical Coding