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This Senior Clinical Data Manager position plays a pivotal role in managing all aspects of the clinical trial data management process. From study start-up to post database lock, you will oversee and execute various tasks to ensure seamless project delivery.
Responsibilities:
- Primary Data Management (DM) contact for assigned clinical projects/programs, ensuring continuity and timely completion of tasks.
- Oversight of project data entry, including development of guidelines, training, quality control, and resourcing.
- Quality control of data entry and provision of input on timelines to meet clinical data management deadlines.
- Assessment and management of resource needs for assigned projects.
- Development of CRF specifications from the clinical study protocol and coordination of review and feedback from stakeholders.
- Database build, conduct UAT, and maintain quality-controlled database build documentation.
- Specification of requirements for edit checks and oversight of their development.
- Maintenance of data management documentation and completeness of Trial Master File documentation.
- Training of clinical research personnel on CRF, EDC, and project-related items.
- Review and querying of clinical trial data according to the Data Management Plan.
- Line listing data review based on sponsor guidance and Lead DM direction.
- Patient and study level status and metric reporting.
- Medical coding of medical terms for logic and consistency.
- Liaising with third-party vendors in support of project timelines and data-related deliverables.
- Assistance with SAS programming and quality control of programs used in Data Management.
- Troubleshooting operational problems and issues for studies using metrics data, audit reports, and stakeholder input.
- Review and feedback on protocols, SAPs, and CSRs as required by the project.
- Participation in SOP and process documentation related to data management and database management activities.
- Attendance at strategy meetings, bid defense prep meetings, bid defenses, capability presentations, and client engagement meetings.
- Review of RFPs and proposals, and provision of project estimates.
- Leadership for cross-functional and organization-wide initiatives as applicable.
- Training and supervision of data management project team members.
- Communication with sponsors, vendors, and project teams regarding data, database, or project issues.
- Presentation of software demonstrations, trainings, department/company training sessions, and project meetings.
