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 vendors
- Ensures the timely initiation, conduct and completion of Data Management activities on clinical trials
- Leads a sub-team of Data Management staff members assigned to a project
- Tracks Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverables
- Authors the Data Management Plan (DMP), outlining all data management responsibilities
- Develops and collaborates with the Database Builder to develop CRF specifications from the study protocol
- Oversees UAT of clinical data systems (EDC, eCOA, IWRS) to be implemented on a project
- Conducts and tracks internal DM team project-specific training throughout the course of the project, as needed
- Attends and presents at project meetings as required
- Oversees the completion of a comprehensive data review of clinical data
- Ensures medical coding and/or Serious Adverse Event Reconciliation is performed in a timely manner
- Assists with protocol deviation review and collaborates with project team on identified issues
- Perform clinical data archiving duties as assigned
- Ensures DM documentation is audit-ready and filed appropriately at all times
- Coordinates all activities in preparation for database lock
- Produces status or progress reports, listings, and other output as required during the course of the project
- Monitors 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 needed
- Perform other duties as assigned by management
Qualifications- Bachelor's degree in a related field of study or equivalent combination of education and work experience
- Minimum 2 years experience in a lead role in Data Management preferred
- CRO experience preferred
- Working knowledge of data management process from study start-up through database lock
- Understands how to prioritize deliverables and proactively address challenges with meeting deadlines
- Basic knowledge of ICH/GCP standards, 21 CFR Part 11
- Basic knowledge of GCDMP Guidelines
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Teams and Zoom
- Effective verbal and writing skills; English + local language, if relevant
- Meticulous attention to detail
- Time management and the ability to prioritize
- EDC experience
- Ability to travel
