Amresh Kumar

Background

About Amresh Kumar

As Functional manager - coaching, mentoring, and developing the assigned team members • As Program Data manager: Provides Data Management leadership for one or more assigned programs/projects or indications. • Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i:e ensuring consistency across data quality plans • Develops an understanding of CDISC or other recognized industry standards and how these impacts the programming team. Ensures consistency of program level standards • Communicates and negotiates effectively with all other Program level team members. Primary point of contact for DM at the GPT level. • Maintains awareness of the status of startup, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by DO DUs & Sr GHs/GHs. • Demonstrates an effective application of knowledge across all DM scenarios. Is able to provide solutions to effectively meet timelines • Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions • Supervises and drives the overall DM timelines across assigned programs. Reviews the Data Management Metrics on the assigned Program. • Ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution. • Develops risk management strategies to prevent data quality issues from derailing projects • Represents Data Management at cross functional forums, meetings and provides timely feedback to partners • Understands Health Authority requirements and is able to prepare for and participate in Health Authority inspections and audits as required