Lead-Clinical data Management

Responsibilities

• Responsible for end to end Clinical Data Management services starting 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.