JEEWAN PRASAD

As a self-motivated Life Science professional, I bring over 12 years of extensive experience in Data Management to the table. My expertise encompasses the full spectrum of Clinical Data Management activities, including study setup, conduct, closure (Database Lock - DBL), and post-DBL submission processes. My comprehensive exposure to these critical phases ensures that I am well-equipped to handle the complexities and demands of data management in the life sciences sector.

• Rave, Inform, Oracle Clinical, MERGE, eClinicalOS.
• DS Navigator (MedDRA & WHODRUG), Oracle Argus.

• I received the Ovation Award from the IQVIA Impact Program for demonstrating customer focus, taking ownership, and being adaptable, particularly with regards to DBL.
• Additionally, AstraZeneca, through PAREXEL, honored me with the Spark Award in recognition of my exceptional integrity and reliability as a data management partner.
• I also earned the Bravo Award at PAREXEL for successfully reaching database go-live milestones and DBLs in a timely manner.

• Maintain training compliance as per Job Roles assigned, including On-the-Job training.
• Deliver Project Specific Training to internal DM team.
• Address training needs, as per Development Goal/s identified.
• Deliver On-the-job training where needed/requested.
• Attended Data Team Lead Conference IQVIA in London, UK.

• Oncology, CV, COPD, Obesity.
• Observational Studies (PMS/Phase IV – Device).
• RWE.

• Independently manage end-to-end delivery of data management services for clinical trials, ensuring quality, timeliness, and budget compliance.

• Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol.

• Develop and maintain data management plans (DMPs), data validation specifications (DVS), and CRF completion guidelines, data transfer agreements (DTA/DRAs), reconciliation specifications etc.

• Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams.

• Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations.

• Ensure adherence to data standards (e.g., CDISC – SDTM, ADaM, CDASH, XML) and regulatory requirements (e.g., FDA, ICH-GCP, HIPAA, 21 CRF Part 11).

• Manage database lock activities and contribute to the preparation of CRF PDF archival and clinical study reports (CSRs).

• Serve as the primary point of contact for data management vendors and oversee their deliverables.

• Participate in study team meetings and provide status updates related to data quality and timelines.

• Support audit readiness and participate in regulatory inspections when required.

• 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 analyze metrics to derive meaningful summary of study health and trends.

• Review of the Master Services/Service Level Agreement, and/or contract to manage toward sponsor-specific metric targets/Key Performance Indicators.

• Host and attend cross-functional meetings. Prepare Meeting Agendas and Minutes, comply to action and decision logs.

• Maintain inspection-ready Trial Master File.

• 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.

• Ensure appropriate project level resourcing for staff and staff assignments. Identify and request functional staff necessary for the project team.

• Regular review and update of DM resources to ensure alignment with contracted budget, project resource forecast, actuals, and demand, utilizing the necessary systems and tools.

• Determine and resolve the root cause of DM related project variance in a timely manner, including negotiating/raising changes in scope.

Cooking, Driving, Travelling, Listening Soft Music.

I hereby declare that the above information is true to the best of knowledge and if you give me an opportunity to work in your organization, I will give my best.