Mayank Gupta

About Mayank Gupta

Clinical Data Management leader with 14+ years of global sponsor and CRO experience, independently managing end-to-end delivery of data management services for single and multi-study projects from start-up through close-out. Proven client-facing Lead Data Manager with strong expertise in project planning, execution, financial oversight, risk mitigation, vendor governance, and inspection readiness. Recognized Oncology Subject Matter Expert (RECIST 1.1) with a consistent track record of delivering complex global studies to scope, quality, timelines, and budget, while mentoring teams and driving continuous process improvements in compliance with GCPs, SOPs, and regulatory requirements.Core CompetenciesClient Management & Primary Point of ContactEnd-to-End DM Service Delivery (Start-up to Close-out)Project Planning, Forecasting & Budget TrackingScope Management & Change Control SupportRisk Identification, Escalation & MitigationVendor & CRO Governance (KPIs, Quality Metrics)Inspection Readiness & Regulatory Compliance (PMDA, MHRA)Oncology Data Management (RECIST 1.1)Training, Mentoring & Matrix Team LeadershipBid / RFP & Business Development Support

Experience

1. Manager

   Biocon Biologics

   Dec 2023 — Present · Bengaluru, IN

   Evaluation of data management capabilities of CRO/ vendors/service providers and due diligence. Oversee the end to end DM services performed by CRO/Vendors 3. Ensure thorough evaluation of processes and services for the startup, conduct and closeout phase of Clinical data management for outsourced services. Manage all aspects of clinical data management such as query management, discrepancy management, UAT, Edit Check in development of EDC.5. Creation, review, approval of data management documents for project set-up, conduct and close out phases. Set KPIs and oversee the clinical data management deliverables of CROs/Vendors 7. Ensure project team and CRO adhere to the timelines and deliverables 8. Define data review requirements and processes to ensure delivery of highest quality data. Review clinical study data/listings including TLFs 10. Oversee and guide CRO during data base lock 11. Set risk and mitigation plan for data management related deliverables. Discuss strategically with stakeholders with respect to data capture elements, trial design, potential risk in study and ensure trials are completed with reduced cost and increased efficiency 13. Oversees Clinical data migration and reconciliation from one system to another system. Keep abreast on new technologies available on holistic review of data and ways to improve efficiencies in data review to improve data quality 15. Undertake SOP preparation/review required for clinical development. Evaluate systems and technology to be used for the trials including EDC, IWRS, ePRO etc. Manages and coordinates the assignment of resources and workload within Data Managers in line with company priorities, ensuring timelines for data management deliverables are met.

Education

• Amity University

  Master's degree, Forensic Science and Technology

  2006 — 2008

• ICRI (INDIA)

  PG Diploma in Clinical Research, Clinical Research and Data Management

  2009 — 2011

• Allahabad Agricultural Institute

  Bachelor’s Degree, Clinical Laboratory Science/Medical Technology/Technologist

  2003 — 2006

Skills

• Good Clinical Practice (Gcp)
• Protocol
• Edc
• Ctms
• Clinical Trials
• Clinical Data Management
• Oracle Clinical
• Pharmaceutical Industry
• Sop
• Ich Guidelines
• Data Management
• Gcp
• Query Management
• Data Validation
• Discrepancy Resolution
• Ich-Gcp
• CRO
• Clinical Research
• Electronic Data Capture (Edc)