Lead Clinical Data Manager

The Lead Clinical Data Manager (LDM) is responsible for the coordination and delivery of Data Management contracted services on assigned projects. This includes meeting internal and external sponsor requirements according to time, quality, scope, and budget parameters. The LDM is the primary point of contact for Data Management on a project, for internal project team members, sponsors, and external data vendors. The LDM presents project-related training and may provide technical guidance and direction to team members. After initial training and onboarding period, this role is expected to work independently and proficiently, taking ownership of their assigned projects. Essential Duties & Responsibilities Serves as the primary Data Management interface for internal project team members, sponsor representatives, third party CROs and external data vendorsEnsures the timely initiation, conduct and completion of Data Management activities on clinical trialsLeads a sub-team of Data Management staff members assigned to a projectTracks Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverablesAuthors the Data Management Plan (DMP), outlining all data management responsibilitiesDevelops and collaborates with the Database Builder to develop CRF specifications from the study protocolOversees UAT of clinical data systems (EDC, eCOA, IWRS) to be implemented on a projectConducts and tracks internal DM team project-specific training throughout the course of the project, as neededAttends and presents at project meetings as requiredOversees the completion of a comprehensive data review of clinical dataEnsures medical coding and/or Serious Adverse Event Reconciliation is performed in a timely mannerAssists with protocol deviation review and collaborates with project team on identified issuesPerform clinical data archiving duties as assignedEnsures DM documentation is audit-ready and filed appropriately at all timesCoordinates all activities in preparation for database lockProduces status or progress reports, listings, and other output as required during the course of the projectMonitors budget and scope of work for contracted DM services throughout the duration of the project, identifying out of scope or budget activities and collaborating with the project manager when out of scope documentation and costs are neededPerform other duties as assigned by management Qualifications Bachelor’s degree in a related field of study or equivalent combination of education and work experienceMinimum 2 years experience in a lead role in Data Management preferredCRO experience preferredWorking knowledge of data management process from study start-up through database lockUnderstands how to prioritize deliverables and proactively address challenges with meeting deadlinesBasic knowledge of ICH/GCP standards, 21 CFR Part 11Basic knowledge of GCDMP GuidelinesProficiency in Microsoft Word, Excel, PowerPoint, Outlook, Teams and ZoomEffective verbal and writing skills; English + local language, if relevantMeticulous attention to detailTime management and the ability to prioritizeEDC experienceAbility to travel