Lead Clinical Data Manager
- Lead all Clinical Data Management tasks for a project including the development of eCRFs, eCRF completion guidelines, Data Management Plan (DMP) and other Clinical Data Management documents in collaboration with applicable service providers and/or internal teams.
- Oversee the implementation of project specific Clinical Data Management Systems and/or processes for assigned projects
- Oversee the implementation of plans for the processing of data within established timelines and budget specifications, and make necessary adjustments based upon project needs.
- Lead clinical data management activities from study start-up through database lock in collaboration with applicable service providers and/or internal teams.
- Design, review, and finalize case report forms (CRFs) in collaboration with cross functional team members.
- Develop and maintain data management plans, data review guidelines, and edit check specifications.
- Oversee database development, validation, user acceptance testing and go live activities
- Monitor data flow, ensure timely and quality data availability for analysis
- Ensure compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
- Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives.
- Manage and collaborate with external vendors, CROs, and partners related to outsourced data management tasks to ensure timely and quality data deliverables.
- Represent data management in cross-functional meetings and communicate project status, risks, and resolutions.
- Provide analysis and feedback (questions, issues and possible resolutions) to the line manager and/or project team on Clinical Data Management tasks, systems or processes.
- Contribute to the development and improvement of data management processes and tools.
- Monitor and manage study budgets to ensure financial efficiency and compliance. Assess change orders, evaluating cost overruns to mitigate financial risk while maintaining study integrity.
- Train and mentor junior team members, promoting best practices in clinical data standards and compliance.
- Participate in audits and inspections, contributing to the development of corrective and preventive actions.
- Communicate with all departments as necessary regarding project status/issues.
- Perform other duties as assigned
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