Senior Lead Clinical Data Manager position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.
Manages DM-related aspects of the program and/or project
Collaborates with the project team on overall data management strategy for the program and/or projects, assuring overall quality and efficiency
Represent DM as the functional lead at internal and sponsor project team meetings
Provides proactive, timely communication of project status, data trends and issue resolution with internal team and Sponsor
Develops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor
Assumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines and providing resource and budget projections
Discusses roadblocks to DM deliverables and potential strategies for overcoming with project team and/or DM management and implements solutions
Performs peer reviews of key DM study documents or other DM deliverables to assure quality of content and, where appropriate, consistency across a program of studies
Reviews and provides DM staffing projections for program and/or projects
Presents EDC and/or CRF completion at Investigator Meetings
Participates in regulatory and Sponsor audits for program and/or projects
Oversees daily team member activities
Serves as a Data Management team leader
Reviews DM team member activities and deliverables to ensure plans and processes are followed
Assures project activities are performed within budget and according to expected timelines and meet high quality standards.
Reviews resource allocation with the assigned DM project leads to ensure projects and budgets are managed effectively
Provides training of DM staff on project specific processes
Oversees the DM project and/or program team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans including but not limited to:
Discrepancy management
Data Reconciliation (e.g., Vendor, SAE) including coordination of transfers and issue resolution with other functional areas and/or 3rd party vendors
Investigation and remediation of reviewer-reported data issues such as from statistical, medical or Sponsor reviews
Assumes ownership for DM project deliverables within DM scope of services including overseeing overall quality, adherence to Study Plans and standard operating procedures, coordinating with manager for resourcing requirements
Oversees System Development and Modifications:
Implements DM strategy on the project/program based on scope of services and as laid out by DM management
Coordinates with Technical Design and Clinical Programming team as well as Project Management to develop and maintain DM startup timelines including the development, testing and implementation of all data capture tools
Coordinates with vendors and cross-functional teams to assure timely completion of tasks to meet established timelines
Coordinates with the Technical Design and Clinical Programming team and/or 3rd party vendor to develop and test the CRF and edit check specifications as well as custom EDC reports to support protocol requirements
Coordinates with the EDC programmers and/or 3rd party vendors in the setup and testing of electronic data capture (EDC) technologies such as Interactive Response Technology (IRT), electronic patient reported outcomes (ePRO), and electronic clinical reported outcomes (eCOA) as required per the scope of work.
Facilitates project team and Sponsor reviews of system documents including but not limited to Time and Events Schedule, CRFs, Edit Checks, revision specifications
Consolidates reviewer comments from internal team/sponsor and collaborates with the project and Clinical Programming team, as required, for revisions
Coordinates with the project team as well as the Technical Design and Clinical programming team to manage post go-live EDC modifications assuring effective implementation (including consistency across program when applicable) and team communication for program and/or projects
Oversees System and Data Listing Testing Activities:
Coordinates testing activities for the EDC technologies per scope of services
Performs testing for EDC systems as required per scope of services and standard operating procedures
Verifies reports created in EDC or other ad hoc reporting tool like J-Review, BOXI and associated change control requests
Provides feedback to the other project team members and managers to improve the deliverables.
Develops, Maintains and Archives DM Project Documentation including:
Data Management Plan, Data Review Plan, CRF Completion Guidelines. and other study-specific plans as required
Data review listing specifications
Database Design Documents, Edit Specifications, Reconciliation guidelines, and Report specifications
Database lock documentation
Represents Data Management at Bid Defense Meetings (BDM)
Prepares project-specific slide presentation from DM template functional slides
Participates in BDM preparation meetings including discussing overall DM strategy
Presents DM slides at BDM and constructively participates in discussion
Continuous Improvement
Recommends and assists in the development of standards and/or improvements to existing standards including processes, CRFs, data listing reports and document templates
Serves as Data Operations mentor
Creates and maintain documentation for templates (DMP, CRF Completion guidelines, Database Design Documents, Edit specifications, Reconciliation guidelines, Report specifications)
Trains others on specific departmental processes including database design document creation, edit check creation, change control processes, database lock
Provides open environment for question/issues about DM topics from within department and cross-functionally