Raman Sehgal
Clinical Research Professional
New Delhi
Summary
A strategic, collaborative servant leader with two decades of experience in the clinical research and drug development industry. Expert in P&L management, setting operational strategy, and driving high-quality trial execution from early phase to Phase 4 studies across CROs, Sponsors and now Sites. Proven track record in resource management, executing cost-saving measures, and ensuring ICH-GCP compliance, while successfully hosting numerous regulatory inspections (EMA and DCGI) with zero critical findings. Results-driven professional with extensive experience in clinical operations and project leadership. Skilled in fostering cross-cultural teams, mentoring staff, and implementing process improvements that enhance quality governance and accelerate timelines.
Overview
20
20
years of professional experience
Work History
General Manager – Medical & Clinical Research Department
Medanta - The Medicity
02.2024 - Current
- Strategic Growth and Program Leadership: Established the long-term vision and strategy for the clinical research division. Developed and launched the Research Support Program (RSP) to incentivize investigator participation and foster innovation. Cultivated strategic partnerships with major sponsors and CROs (e.g., Pfizer, BMS, AZ, IQVIA, Fortrea, Parexel) and Bio-NEST bioincubators like the Regional Centre of Biotechnology, the Translational Health Science and Technology Institute (THSTI), and iHub Anubhuti - Indraprastha Institute of Information Technology Foundation (IIIT-D), a leading Technology Innovation Hub (TiH), to increase the volume and complexity of the research pipeline.
- Financial Ownership and Revenue Generation: Held complete financial ownership of the research portfolio, including P&L oversight, and timely revenue realization. Increased clinical research revenue from INR 15 million (2023-24) to INR 35 million (2024-25), demonstrating significant business growth.
- Operational Excellence and Timeline Acceleration: Accelerated operational timelines by implementing critical process improvements that reduced study start-up times by nearly 50% through fast-tracked Clinical Trial Agreement (CTA) executions. Successfully managed a diverse Phase I-IV portfolio while establishing quality governance.
- Ethical and Regulatory Integrity: Ensured strict ethical and regulatory integrity by serving as an IRB member and maintaining adherence to global compliance standards across all phases of the trial lifecycle.
- Executive People Leadership: Leading and mentoring high-performing clinical operations teams, including Senior Research Coordinators, Operational Managers, Project Managers, Lab Managers, Senior Research Pharmacists, and Nursing Staff, driving performance and professional development.
- Developed and managed budgets for all sponsored clinical trials, ensuring fiscal responsibility while maximizing research capabilities and resources.
Director and Head Clinical Operations
PFC Pharma Focus India Pvt. Ltd.
05.2017 - 02.2024
- Established and scaled a successful CRO, driving P&L management, and controlling the financial forecast to ensure optimal revenue realization.
- I provided executive leadership for all regulatory submissions, implemented risk management and quality frameworks, and mentored high-performing teams to consistently deliver optimal project execution across complex therapeutic areas. Managed financial forecasts and program performance to achieve departmental targets.
- Delivered significant regulatory success, including US FDA approvals. Supported the clinical development of the first multiple myeloma drug in the second-line setting since 2016. A drug was approved by the US FDA under the accelerated approval pathway. Study results presented at the American Society of Hematology in December 2020, and at the annual meetings of ASCO and the European Hematology Association in June 2021. Pivotal Phase 3 study results were published in The Lancet in November 2020. It forms the basis for the US FDA approval. A novel anti-cancer drug for DLBCL was granted conditional marketing authorization by the European Commission in March 2021. Results published in The Lancet Haematology, July 2020. Positive topline Phase 2 data were presented to the US FDA in January 2023 for the treatment of persistent corneal epithelial defect.
- Study drug combinations were added to the Clinical Practice Guidelines in Oncology by the National Comprehensive Cancer Network in December 2020.
- Successful eTMF inspection in January 2022 by the EMA for a Phase 3 Multiple Myeloma study. No critical or major findings.
- Successful sponsor site audit for an oncology study (Phase 2 Head and Neck Squamous Cell Carcinoma). No critical or major findings.
- Lead the Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards, and operational procedures.
- Served as the primary contact for customers, providing project status updates to executive leadership.
- Supported sales processes by preparing proposals and participating in bid defense meetings.
Senior Project Manager
Novartis Healthcare Pvt. Ltd.
06.2016 - 10.2016
- Drove strategic alignment by implementing project plans, and overseeing resource allocation. Successfully mentored junior project managers, enhancing team performance and skills development.
- Managed project timelines, budgets, and resources throughout the project lifecycle effectively.
- Facilitated stakeholder meetings to gather requirements, and ensure alignment on projects.
- Analyzed project risks and devised proactive mitigation strategies to minimize impact.
Senior Manager
Quintiles Research India Pvt. Ltd. (now IQVIA)
10.2009 - 05.2016
- Drove Regional Operational Excellence and Strategy: Progressed through four promotions to Senior Manager, leading clinical monitoring teams for two regional offices in India, and overseeing operations across Bangladesh and Sri Lanka. Played a crucial role in the India leadership team, formulating strategic goals, and ensuring operational excellence in alignment with corporate priorities.
- Delivered transformative quality and regulatory success: held complete ownership of quality governance, utilizing PDQ (Productivity, Delivery, and Quality) indicators. Successfully hosted two EMA inspections and submitted a pre-timeline CAPA that resulted in the downgrading of major findings, leading to marketing authorization. Successfully led a regional re-monitoring assignment (Philippines) that completed CAPA ahead of schedule, and saved significant costs.
- Executive Management and FSP Account Leadership: Served as Line Manager for a large group of clinical professionals (CRAs, CTLs, CTAs), driving employee engagement, performance planning, and managing the CRA School program. Managed large-scale FSP accounts (e.g., Eli Lilly and Biogen Idec), and was responsible for transitioning studies from competing CROs.
- Leveraged PeopleSoft and other core financial systems to track operational budget metrics, forecast resource utilization, and drive cost-control strategies.
Sr. Clinical Research Associate
ICON Clinical Research
07.2008 - 10.2009
- Managed and led Phase 3 trial operations across multiple sites, encompassing the full lifecycle from site identification, regulatory submissions, to negotiating financial contracts (CTAs). Maintained high team performance through mentoring CRAs, overseeing all monitoring activities, site initiation, and essential document finalization. (Indications: Vaccines and Neurology.)
- Trained and mentored junior clinical research associates, fostering a collaborative environment to enhance team performance.
Sr. Clinical Research Associate
GVK BIO
04.2007 - 07.2008
- Managed and oversaw the full clinical trial lifecycle at the site level, functioning as a Lead CRA to ensure timely delivery of high-quality data. Owned site budgets, driving the development, and successful negotiation of Clinical Trial Agreements. Ensured strict adherence to the protocol, SOPs, ICH-GCP, and all regulatory requirements. (Indications: Immunology, Neuropsychiatry, and Oncology.)
Clinical Research Associate
ICON Clinical Research
10.2006 - 04.2007
- Executed full-cycle trial activities (pre-trial, trial, and post-trial), ensuring strict adherence to GCP/SOPs.
- Collaborated with cross-functional teams to streamline project timelines, resulting in improved efficiency and reduced turnaround times for study deliverables.
- Conducted site initiation visits and monitoring activities, identifying potential issues early to maintain adherence to study protocols and enhance patient safety. (Indications: Endocrinology (T2DM) and Neurology.)
Executive - Clinical Research
Panacea Biotec
11.2005 - 09.2006
- Managed the full clinical trial lifecycle (feasibility, site selection, initiation, and monitoring), and supported regulatory affairs. Unique contribution as a CRA who published the results of a Phase 2 study in an international journal, demonstrating expertise in medical writing (protocol, Investigator's Brochure, Clinical Study Reports). (Indications: Vaccines, musculoskeletal pain management, and anti-infectives.)
Education
Master of Science - Pharmacology
All India Institute of Medical Sciences
New Delhi, India01-2005
Bachelor of Pharmacy - Pharmaceutical Sciences
Jamia Hamdard University
New Delhi, India01-2003
Diploma in Pharmacy - Pharmaceutical Sciences
Jamia Hamdard University
New Delhi, India01-1999
Skills
Leadership Excellence - Strategic Planning & Execution, Cross-Cultural Team Management, Change Management & Innovation, Conflict Resolution & Problem Solving, Team Building, Performance Improvement
Interests
Expeditionary Travel & Cross-Cultural Immersion
Accomplishments
- Drug Approvals, Supported clinical development of first Multiple Myeloma drug in second-line setting since 2016, achieving FDA accelerated approval.
- Revenue Growth, Successfully managed $50M+ clinical trial portfolios with 98% on-time delivery.
- Operational Excellence, Achieved zero critical findings in 15+ regulatory inspections (EMA, DCGI,).
- Innovation Leadership, Published 10+ peer-reviewed publications in international journals.
- Team Development, Built and mentored 50+ clinical professionals across multiple regions.
- Recognition received 30+ performance awards for leadership excellence and customer centricity.
- Process Optimization, Implemented RBQM strategies reducing monitoring costs by 25%.
- Thought Leadership, Moderate LinkedIn's largest clinical research community and ISCR.
AWARDS & HONORS
Provided safety data in response to the query generated by the regulatory office/MOH which subsequently led to the resumption of study in India. 'Employee of the year' at GVK Biosciences, October 2007., Certificate of Recognition for Customer Centricity from Mr. D. S. Brar, Chairman, GVK Biosciences & ex-CEO and MD, Ranbaxy Research Laboratories., Certificate of Recognition for outstanding achievement from Wyeth in 2007 (now Pfizer)., Proven Leadership in Quality and Compliance: Received the Executive Management VIP Award following a successful EMA inspection (2016) for timely CAPA submission, complementing 30+ performance awards at Quintiles for leadership, teamwork, and quality initiatives., Industry Influence and Community Building: Moderates the largest LinkedIn group for Clinical Research Professionals (recipient of an engagement award) and transformed the Indian Society of Clinical Research community to ~60K active members (as of Nov 2025).
TRAINING
- Advanced Clinical Research Training by The Texas Medical Center, Houston TX and SOCRA held on October 27th and November 3rd, 2023.
- Skill Development Programme on Pharmacovigilance of Medical Products organized by NCC-PvPI, Indian Pharmacopoeia Commission from 6-10 Feb 2023.
- Regulatory Pathways to Innovative Clinical Trials conducted by Indian Society of Clinical Research on 26 Feb 2022.
- Submission of Quality Data to Regulators in Collaboration with USFDA held on 25 Feb 2022.
- Regulatory Pathway Workshop on New Drugs and Biopharmaceuticals organized by Innovation Technology Transfer Office (i-TTO), IIT Delhi in association with Clinical Development Services Agency (CDSA), Translational Health Science and Technology Institute (THSTI) on 14 Dec 2021.
- Hands on Training Programme on GCP conducted by CDSA on Jan 28-29, 2020.
- Diversity and Inclusion by Novartis Learning and Development, 2016.
- Manage, Lead and Succeed by Quintiles L&D from 2-4 Dec 2009.
- Barnett Accreditation: Expert GCP EXAM for managers and staff interacting with investigational sites (2012).
- Leading for Performance, by Forum Corporation, Singapore on 8-9 March 2010.
- Coaching and Collaboration, by Forum Corporation, Singapore on 23-24 June 2010.
- Franklin Covey Leadership Workshop - 7 Habits of Highly Successful People, Apr 2011.
- Workshop on 'Dangerous Goods Awareness with Concentration on Preparing, Handling and Transporting Infectious Substances by Air', organized by World Courier (India) Pvt. Ltd. on 7 Feb 2006.
SELECTED PUBLICATIONS
- Reinventing Patient Recruitment - Achieving accelerated clinical endpoints through a revolutionary patient recruitment model. Jeff Parke and Sehgal R. Pharma Focus Asia 2023. Issue 50, 48-51.
- A phase II randomized controlled trial to evaluate the safety and efficacy of Praneem polyherbal vaginal tablets compared with betadine vaginal pessary in women with symptoms of abnormal vaginal discharge. Sehgal R, Talwar GP, Salhan S, Tripathi V, Chatterjee A, Kumar G. Asia Pac J Public Health 2009 Oct;21(4):461-8.
- Calotropis procera latex-induced inflammatory hyperalgesia - effect of anti-inflammatory drugs. Sehgal R, Kumar VL. Mediators of Inflammation 2005 (4), 216-220.
- Antioxidant and protective effect of latex of Calotropis procera against alloxan-induced diabetes in rats. Roy S, Sehgal R, Padhy BM and Kumar VL. Journal of Ethnopharmacology 102 (3), 470-473.
- Inhibitory effect of extracts of latex of C. procera against Candida albicans - A preliminary study. Sehgal R, Arya S and Kumar VL. Indian Journal of Pharmacology 2005; 37: 334-335.
- A comparative study on the efficacy of rofecoxib in monoarticular arthritis induced by latex of Calotropis procera and Freund's complete adjuvant. Kumar VL, Roy S, Sehgal R and Padhy BM. Inflammopharmacology 14 (1), 17-21.
- Evaluation of cytotoxic potential of latex of Calotropis procera and Podophyllotoxin in Allum cepa root model. Sehgal R, Roy S and Kumar VL. Biolol 30 (1), 9-13.
- Calotropis procera latex-induced inflammatory hyperalgesia – effect of bradyzide and morphine. Kumar VL and Sehgal R. Autonomic and Autacoid Pharmacology 27 (3), 143-149.
- An update on new drug discovery & development from molecular approaches. Sehgal R, Nandave M and Ojha S. Pharmatimes 2006; 38 (5):22-25.
- Anti-hyperglycemic effect of latex of Calotropis procera in alloxan induced diabetes. Kumar VL, Roy S, Sehgal R and Padhy BM. Inflammation Research; 54, S193-S194.
- Audits in Clinical Trials. Sehgal R. The Pharma Review 2007; 5(29):61-65.
- Outsourcing Clinical Trials to India - Opportunities and Challenges. Sehgal R. The Pharma Review 2009; 29-30.
- Pharmacovigilance: Role and Importance in Pharmaceutical Industry. Sharma M, Gupta SK, Chatterjee A, Gupta VB and Sehgal R. The Pharma Review 2009; 53-56.
- Sehgal R et. al. Pharmacoepidemiology. Practice of Hospital, Clinical and Community Pharmacy Practice edited by Mohd. Aqil, first edition, Elsevier Health, 2012, Chapter 8.
- Sehgal R et. al. Rational Drug Use and Essential Medicines Concept. Practice of Hospital, Clinical and Community Pharmacy Practice edited by Mohd. Aqil, first edition, Elsevier Health, 2012, Chapter 17.
- Sethi's HPLC - High Performance Liquid Chromatography: Quantitative Analysis of Pharmaceutical Formulations, Vol. 1-4. CBS Publishers and Distributors Pvt. Ltd., New Delhi, India. 2010.
- Elements of Pharmacovigilance – Be Vigilant, Be Safe. Sehgal R et. al. Kongposh Publications, New Delhi, India. 2010.
References
- Suchela, Srivatsa, Senior Director & Head Central Operations, Clinical FSP, IQVIA India, suchela.srivatsa@iqvia.com, +91-9820712114.
- Jahanara, Nayar Rahuldev, Vice President FSP Biometrics, Parexel, jahanara.rahuldev@parexel.com, +91-9886495753.
- Larisa, Nagra Singh, Head of Commercial, ICON Plc., Singapore +65 97271631
- Shabbir, Rangwala, Group Vice President Global Clinical Operations, Glenmark Pharma, shabbir.rangwala@glenmarkpharma.com, +91-9910999332
Timeline
General Manager – Medical & Clinical Research Department
Medanta - The Medicity
02.2024 - Current
Director and Head Clinical Operations
PFC Pharma Focus India Pvt. Ltd.
05.2017 - 02.2024
Senior Project Manager
Novartis Healthcare Pvt. Ltd.
06.2016 - 10.2016
Senior Manager
Quintiles Research India Pvt. Ltd. (now IQVIA)
10.2009 - 05.2016
Sr. Clinical Research Associate
ICON Clinical Research
07.2008 - 10.2009
Sr. Clinical Research Associate
GVK BIO
04.2007 - 07.2008
Clinical Research Associate
ICON Clinical Research
10.2006 - 04.2007
Executive - Clinical Research
Panacea Biotec
11.2005 - 09.2006
Master of Science - Pharmacology
All India Institute of Medical Sciences
Bachelor of Pharmacy - Pharmaceutical Sciences
Jamia Hamdard University
Diploma in Pharmacy - Pharmaceutical Sciences
Jamia Hamdard University