Responsible for end to end Clinical Data Management services stating from Clinical Database Set Up to Database Lock.
Representing Data Management services to Local and / Global Sponsors
Providing CAPA to Internal Audits, External Audits and Regulatory Inspections
To ensure expedited resolutions on critical/significant changes/query required in projects as per feedback from sponsor
Developing and revising SOPs, WIs (Working Instructions), Presentations on all CDM process.
Training team on data management processes in compliance with current guidelines , Regulations and Industry Practices.
Communication with sponsor on all project management related activities like DM Project start up, Planning timeline, deliverables for projects, Project progress and Project closure
Communication with all cross functional teams – Clinical Operation team, SAS & Bio-statistics team, Medical writing team, Central Lab including external vendors as required in a project
Heading DM project team kick-off meetings & follow-up meeting
Protocol review as per Data Management prospective
Provide leadership and motivation to DM team, setting team KRAs, completing task allocation, and determine resource needs
Review and approval of timesheet of all DM staff.
Reviewing and approving all CDM projects documentation and process
Escalation of significant issues to Senior Management for DM Projects
Any Other responsibilities as assigned by Reporting Head and / Senior Management
Ensure compliance to applicable rules, regulations, guidelines, standard operating procedures (SOPs), work instructions (WIs) and policies etc. for conducting delegated activities.
leads process development, audits, training, and project management activities, while providing leadership and guidance to the team, ensuring timely and high-quality delivery of data
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