Subham Kumar
Global Study Manager | Clinical Trial Operations, Project Management & Vendor Management Professional | PGP Business Analysis, Purdue University | MBA-Operations Management, SGVU | B.Pharmacy, RGTU
- Role
- R & d Clinical Trial Support Manager Associate Global Study Manager at Sanofi
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Subham Kumar
Strategic and results-oriented Clinical Trial Manager / Global Study Manager with 9+…
Experience
R & d Clinical Trial Support Manager Associate Global Study Manager
May 2025 — Present · Hyderabad, IN
Provide end-to-end operational support for global clinical trials, ensuring the development, review, and maintenance of essential study documents (e.g, SRMP, Monitoring Plan, CTAs, training materials, recruitment plans) in compliance with Sanofi SOPs and regulatory requirements.• Oversee Trial Master File (TMF) and CTMS documentation, ensuring accuracy, completeness, and inspection readiness; manage SharePoint content for study materials.• Support study budget development, quarterly forecasting, and final reconciliation; track vendor payments and collaborate with clinical buyers to resolve invoice discrepancies.• Coordinate and lead internal and external meetings (study teams, vendors, COSCLs), maintain study logs (actions, decisions, risks), and contribute to data review, RBM, and monitoring strategy discussions.• Manage clinical sample logistics in collaboration with translational medicine and lab vendors, ensuring timely tracking, reconciliation, andresolution of operational issues.• Support IMP supply planning, shipment coordination, and reconciliationprocesses.• Participate in audit and Pre-Approval Inspection (PAI) readiness activities, contribute to response development, and implement corrective actions using Sanofi’s inspection-readiness tools.• Train and support Clinical Trial Assistants (CTAs), ensuring adherence to study-specific processes and promoting continuous process improvement.
Education
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Bachelor of Pharmacy (B.Pharm.), Pharmacy
2012 — 2016
Purdue University
Postgraduate Program, Business Analysis
Suresh Gyan Vihar University
Master of Business Administration - MBA, Operations Management and Supervision
2017 — 2019
Skills
- Clinical Trial Management System (Ctms)
- Microsoft Office
- Electronic Common Technical Document (Ectd)
- Clinical Research
- Ich-Gcp
- Observational Studies
- Clinical Operations
- Tmf
- Pharmacovigilance
- Clinical Gdn
- Clinical Site Management
- Operations Management
- Pivotal Tracker
- Workflow Management
- Clinical Trial Management
- Clinical Data Management
- Powerpoint
- Microsoft Excel
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