Manish Kulkarni

Principal Clinical Data Scientist @Novartis

Provide Data Management leadership for one or more assigned programs or indications. Demonstrate a business understanding of the compound profile to identify and assist in successful application of consistent data management processes and documentation across assigned programs\\\\n• Develop an understanding of CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards\\\\n• Communicate and negotiate effectively with all other Program level team members. Primary point of contact for DM at the GPT level\\\\n• Maintain awareness of the status of start up, conduct and finalization activities for all trials within assigned program(s). Track and request necessary resources\\\\n• Demonstrate an effective application of knowledge across all DM scenarios & provide solutions to effectively meet timelines\\\\n• Manage effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions\\\\n• Supervises and drives the overall DM timelines across assigned programs. Reviews the Data Management Metrics on the assigned Program. Coach and mentor associates as required, ensure that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution.\\\\n• Develop risk management strategies to prevent data quality issues from derailing projects\\\\n• Represents Data Management at cross functional forums, meetings and provide timely feedback to partners\\\\n• Understands Health Authority requirements and is able to prepare for and participate in Health Authority inspections and audits as required\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n