Subham Kumar
Summary
Strategic Clinical Trial Manager with 10 years of progressive global experience driving end-to-end clinical operations excellence across Phase I–IV trials in pharmaceutical and CRO environments. Demonstrated expertise in full lifecycle trial management — from protocol development and site identification through database lock and regulatory submission — with a strong track record of delivering complex, multi-regional studies on time and within budget. Deep proficiency in risk-based monitoring, vendor governance, and cross-functional leadership, with hands-on experience managing specialized vendors including eCOA, central laboratory, home nursing, and patient reimbursement platforms. Recognized for building scalable operational frameworks, standardizing processes, and mentoring high-performing clinical teams. Technically adept in CTMS, eTMF, EDC, COUPA, Spotfire, and Infosario. Committed to operational excellence, inspection readiness, and patient-centric trial execution in alignment with ICH-GCP and evolving global regulatory standards.
Overview
10
10
years of professional experience
Work History
R&D Clinical Trial Support Manager
Sanofi Healthcare India Private Limited
Hyderabad
05.2025 - Current
- Spearhead comprehensive operational delivery across global clinical trials, with accountability for end-to-end study documentation — encompassing SRMP, Monitoring Plans, recruitment strategies, and training materials — in full alignment with Sanofi SOPs and applicable regulatory frameworks.
- Coordinate and manage regulatory submission activities, including EU-CTR filings and cross-functional liaison with regulatory affairs teams to ensure timely and compliant submissions.
- Lead the identification, evaluation, and qualification of investigator sites globally; utilize strategic platforms including Inato to optimize site engagement, strengthen the site pipeline, and support enrollment planning.
- Execute full-lifecycle vendor oversight — spanning initial selection, contract negotiation, ongoing performance management, and formal closeout — for a diverse portfolio of specialized service providers including Clario (eCOA/Cardiac Safety), Accellacare (Home Nursing), Greenphire (Patient Reimbursements), central laboratories, imaging vendors, and clinical logistics partners, with a consistent focus on deliverable quality, data integrity, and milestone adherence.
- Ensure Trial Master File (TMF) and CTMS records are maintained to inspection-ready standards at all times; administer study-specific SharePoint repositories and oversee centralized content management.
- Drive financial governance across the study portfolio, including budget development, quarterly spend forecasting, and cost reconciliation; proactively manage vendor invoicing cycles and resolve payment discrepancies in collaboration with clinical procurement stakeholders.
- Chair and facilitate key study governance meetings; own and maintain study-level logs capturing actions, decisions, and risks; actively contribute to data review sessions, Risk-Based Monitoring (RBM) strategy development, and monitoring plan refinement.
- Implement In-Process Control (IPC) activities throughout study execution, encompassing real-time data surveillance, quality control evaluations, process validation exercises, and corrective action deployment to safeguard ongoing study integrity and regulatory compliance.
- Own the study risk management lifecycle — from initial risk identification and criticality assessment through mitigation planning and continuous monitoring — utilizing the SRMP framework to define Critical Data (CD) and Critical Processes (CP) and maintain robust risk control strategies.
- Contribute to Investigational Medicinal Product (IMP) supply chain operations, including demand forecasting, shipment coordination, and inventory reconciliation across study sites.
- Oversee the end-to-end Protocol Deviation management process — from identification and root cause analysis through formal documentation, escalation, and resolution — in strict accordance with ICH-GCP guidelines and Sanofi SOPs.
- Support audit preparedness and Pre-Approval Inspection (PAI) readiness activities; facilitate mock inspection exercises, develop and maintain inspection-ready documentation packages, and drive CAPA implementation leveraging Sanofi's inspection readiness toolkit.
- Coach and develop Clinical Trial Assistants (CTAs) and junior team members, embedding a culture of process adherence, quality consciousness, and continuous improvement across the study team.
- Champion hub-level operational transformation through the development of RACI matrices for CSSO team functions, design and delivery of multi-functional process maps, establishment of a clear CTSM/CTSA role distinction framework, and creation of structured R&D onboarding programs for incoming Sanofi hires — driving organizational clarity, cross-functional collaboration, and operational standardization across the Hyderabad hub.
Clinical Trial Project Integration Manager- Oncology
IQVIA RDS (India) Private Limited
Hyderabad
07.2023 - 05.2025
- As a Project Integration Manager, I assist in the execution of the assigned clinical study(ies) per Contract, from initiation through to closeout
- Established and owned vendor management frameworks, integrating operational plans into the IPMP through direct collaboration with third-party vendors and ancillary service providers.
- Defined vendor-specific KPIs and conducted structured performance evaluations, holding vendors accountable to contracted scope, quality standards, timelines, and cost parameters.
- Served as central point of contact for clients, suppliers, and internal stakeholders, ensuring seamless communication and uninterrupted project continuity.
- Anticipated and mitigated project and vendor risks through structured contingency planning and timely corrective action implementation.
- Acted as primary backup Sponsor contact, maintaining consistent stakeholder alignment and communication across all project phases.
- Delivered project performance updates and vendor status reports at internal and external governance meetings.
- Coached and developed junior project management staff on vendor management best practices and operational standards.
Project Specialist -II
CLINIPACE Clinical Research Private Limited
09.2021 - 07.2023
- Coordinating for project KOM preparation, scheduling internal and external meetings, take minutes, update action, decision, issue, and project risk logs
- Draft project plans
- Manage and update study Finance, vendor invoices, update project schedule, track site payments & maintain eTMF
- Acts as first point of contact for other team members on the project as needed, resolving issues where applicable and acting as PM designee
- Coordinating cross functional units for various updates
- Coordinate with vendor and clinical sites for invoices & final payment confirmation
- Maintain the data in various company specific applications, create and review performance metrics and training records
- Update and maintain data within the source systems with attention to quality and timeliness of entry
Project Management Analyst
IQVIA RDS (India) Private Limited
Hyderabad
01.2020 - 09.2021
- Establish and maintain project monitoring, control and reporting system that supports on-going assessment of project performance and facilitates informed and timely adjustment of project execution to achieve project objectives
- Facilitate timely project execution and study delivery to client within the contracted timelines
- Develop and maintain the Integrated Project Management Plan with the PL
- Apply strong time management, planning, organizational, decision making and problem-solving skills to resolve issues in an effective and timely matter
- Direct and coordinate project scheduling, finance, and risk management
- Assure effective project reporting: Cost, schedule, scope, change orders, quality and risk reporting and Prepare study team and customer correspondence
- Providing analysis and reporting of variances to the Performance Measurement Baseline (as established in the IPMP)
- Identifies risks
Senior Clinical Trial Assistant
IQVIA RDS (India) Private Limited
Hyderabad
09.2016 - 01.2020
- Co-ordinate and optimize workflow management for specific business areas to assist in the delivery of departmental targets
- Analysis and reporting of daily, weekly, monthly, and ad hoc performance highlighting key drivers of the results
- Approve payments to investigator, institutes and subjects participating in clinical Trials in accordance with sponsor and company requirements
- Also reviews Clinical Trial Agreements and CTA amendments to ensure payments are made as per the documented payment terms and schedule
- And identifies and works with clinical team to follow up on invoice discrepancies
- Ensure and verifies that all essential documents are filed in e-TMF and tracked in Clinical database (CTMS) indicated as per internal SOP guidelines
- Ensures that Clinical Trial Assistants continue to follow any study specific instructions, when required
- Assisting Site and Patient Services with process development and keeping up to date with the latest developments, as well as training CTAs on new development
- Assist in assigned project(s), sites, and project teams
- Ensure all work is conducted in accordance with SOPs, policies and practices, good clinical practices and applicable regulatory requirements and meets quality and timeline metrics
Education
Master of Business Administration (MBA) - Operations Management
Suresh Gyan Vihar University
Jaipur, Rajasthan01-2019
Bachelor of Pharmacy (B. Pharm) -
Rajiv Gandhi Technical University
Bhopal, Madhya Pradesh01-2016
Skills
- Project Finances
- Budget Management
- Vendor Management
- Risk Management
- Stakeholder Management
- Project Plans (IPMP, Communication Plan, Vendor Management Plan, Finance Management Plan, Operations Plan)
- Change Order Management
- Project Dashboarding
- MS Office tools (Excel, PowerPoint, Word)
- Schedule Management
- Clinical Systems (CTMS, TMF, DrugDev, APEX, EDC)
- Project Management Systems (COUPA, Spotfire, SharePoint,
Infosario, PPM) - Clinical Supply Management (IP, Medications and other supplies)
Websites, Portfolios and Profiles
linkedin.com/in/subham-kumar-829996122
Advanced Training & Certifications
- Clinical Trial Management and Advanced Operations from The Johns Hopkins University, 2025
- GCP Certification Exam, 2023
- Post Graduate Program in Business Analysis from Purdue University, 2023
- Certified Business Analysis Program from Simplilearn, 2022
- Advance Post-Graduate Program in Clinical Research and Management (APCRM) from CLINIINDIA, 2016
Awards & Honors
· Bravo Award for “Lead Together- Driving hub-level operational excellence initiatives fostering organizational clarity, team collaboration, and operational standardization across the hub by CTSM Team Lead, 2026-04-30, at Sanofi.
· Bravo Award for "Aim Higher - Rising to the Challenge with Determination" by Global Trial Team Lead, 2025-12-04, at Sanofi. This recognition reinforces my commitment to embracing challenges with determination and delivering excellence in clinical trials.
· Nominated for IQVIA IMPACT Program and awarded as Employee of the Month, 2020-08-01, Bronze Award
· IQVIA Bravo Award by Pharmacyclics Study, 2019-01-01, Lead for my extra efforts and hard work for achieving specified goals
· IQVIA Distinction Award by Sr. Manager, 2019-01-01, For my extra efforts and hard work for achieving specified goals in multiple projects and meeting the set timelines
· IQVIA Bravo Award by Line Manager, 2018-01-01, For my extra efforts and hard work for achieving specified goals in multiple projects.
· IQVIA Recognition award by GSK SABLE Study, 2018-01-01, Project Manager for completing the tasks with significant efforts
· IQVIA Applause Award by Line Manager, 2018-01-01, For all initiatives taken for the success of WML tasks/projects
· IQVIA Applause award by Johnson & Johnson (Janssen) Study, 2017-01-01, Clinical Project Manager for my wonderful completion of the backlog tasks before the timeline and targeted date
· IQVIA Recognition award by Line Manager, 2017-01-01, For my excellence in designing CTA Project Tracker for all the projects of RWE CTA Team India
IQVIA Recognition award by Circassia Study, 2016-01-01, Clinical Project Manager for completing the tasks with heroic efforts
Timeline
R&D Clinical Trial Support Manager
Sanofi Healthcare India Private Limited
05.2025 - Current
Clinical Trial Project Integration Manager- Oncology
IQVIA RDS (India) Private Limited
07.2023 - 05.2025
Project Specialist -II
CLINIPACE Clinical Research Private Limited
09.2021 - 07.2023
Project Management Analyst
IQVIA RDS (India) Private Limited
01.2020 - 09.2021
Senior Clinical Trial Assistant
IQVIA RDS (India) Private Limited
09.2016 - 01.2020
Master of Business Administration (MBA) - Operations Management
Suresh Gyan Vihar University
Bachelor of Pharmacy (B. Pharm) -
Rajiv Gandhi Technical University