Sandeep Agarwal

About Sandeep Agarwal

Compassionate Clinical data management professional with around 11+ years of Clinical Data Management experience• Possess knowledge with comprehensive understanding and practical knowledge in the field of ICH GCP Guidelines, CFR Guidelines, CRF’s, Protocol, ICF, and Schedule Y• Worked on therapeutic areas of Oncology, Rheumatology, Dermatology, Neurology, and Infectious Diseases etc.(both on drugs and devices)• Possess experience on Set up, Maintenance and Close out phases with successfully setting up more than 10 studies and have achieved many milestones before the timelines• Good diagnostics skills, expertise in identifying issues, forming hypothesis, designing, and conducting analysis, synthesizing conclusions into recommendations and implementing changes.

Experience

1. Senior Data Management Lead

   Parexel

   Sep 2022 — Present · IN

   Acting as a mentor for ADMLs, DMLs and other Senior DML peers.• Prepare for and participate in Bid Pursuit meetings and Investigator meetings.• Manage and coordinate the integration and utilization of all ancillary systems as appropriate.• Highlight issues/risks to delivery by understanding interdependencies. Define mitigations and drive to resolution with cross-functional stakeholders as part of Risk Management Plan.• Review and analyse metrics to derive meaningful summary of study health and trends• Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs.• Prepare for and participate in study or program-level Bid Pursuit preparation meetings.• Portray Parexel\'s technical and operational expertise and capabilities, and tailor to meet sponsor\'s specific needs.• Create relevant slides with cross-functional Global Data Operations input as appropriate.• Present with confidence and as a cohesive Parexel team with other functions• Ensure compliance to Standard Operating Procedures, ICH/GCP Guidelines.• Maintain inspection-ready Trial Master File.• Identification of quality issues, ensuring they are raised in relevant system and closed according to requirements.• Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies.• Drive and implement Corrective/Preventive actions for study, and work toward alignment across Parexel as appropriate - share lessons learned across multiple projects within a program or therapeutic area.• Determine and resolve the root cause of DM-related project variance in a timely manner, including negotiating/raising changes in scope.• Participate in creation/review of SOP process and/or templates - provide input as a Subject Matter Expert (SME) where necessary.• Address training needs, as per Development Goal/s identified and deliver On-the-job training where needed/requested.• Deliver On-the-job training where needed/requested.

Education

• Cranfield University

  Msc in Clinical Research, Clinical research

  2009 — 2011

• Nalanda Degree College

  BSc Biotechnology, Biotech, Zoology, Chemistry

  2006 — 2009