Soham Shah
Whitehouse Station,NJ
Summary
Dynamic clinical operations professional with over 17 years of experience in clinical operations, people management, and project management. Proven track record in driving operational excellence, streamlining processes, and leading high-performing teams to execute complex clinical programs successfully. Committed to fostering innovation and efficiency while delivering strategic results. Eager to embrace a challenging role that promotes growth, learning, and significant impact within the organization.
Overview
18
18
years of professional experience
Work History
Senior Clinical Study Lead
Regeneron Pharmaceuticals, Inc.
New Jersey, USA
06.2023 - Current
- Clinical Trial Leadership & Strategy
- Lead cross-functional study teams to deliver complex clinical trials, serving as the primary operational leader and strategic decision-maker for assigned studies.
- Drive protocol development by providing expert operational insights aligned with study objectives and regulatory expectations.
- Develop, review, and approve key study documentation (CRFs, DMP, monitoring plans, training plans, DRPs, SAPs) ensuring scientific rigor and audit readiness.
- Direct the setup, integration, and maintenance of critical clinical systems, including CTMS and TMF, ensuring accuracy, compliance, and inspection preparedness.
- Ensure full compliance with clinical trial registry requirements across global regions.
- Vendor, Budget & Timeline Oversight
- Identify outsourcing needs and lead vendor selection, contracting, governance, and ongoing performance oversight to ensure delivery against scope.
- Contribute to baseline budget and timeline development; proactively manage and track variances, escalating risks and implementing corrective actions.
- Oversee study drug forecasting, clinical supply management, accountability, and reconciliation in collaboration with internal and external stakeholders.
- Operational Delivery & Risk Management
- Lead comprehensive study-level risk assessments and implement actionable mitigation plans to safeguard timelines, quality, and patient safety.
- Drive regional and country feasibility assessments to inform robust site-selection strategies.
- Oversee site qualification, activation, and monitoring performance, intervening quickly to correct underperformance or deviations.
- Lead planning, development, and execution of investigator meetings to ensure high-quality study conduct and engagement.
- Develop and oversee patient recruitment and retention strategies, proactively addressing barriers to enrollment.
- Data Quality, Compliance & Inspection Readiness
- Monitor data entry, query management, protocol deviations, eligibility and dosing violations, and suspected non-compliance, driving timely resolution and preventive actions.
- Ensure study audit and inspection readiness throughout the lifecycle; support audit/inspection activities and develop/implement CAPAs.
- Provide oversight of CROs and third-party vendors to ensure alignment with contractual deliverables, quality expectations, and operational standards.
- Lead study close-out activities including database lock, TMF reconciliation, vendor contract closure, and drug accountability.
- Contribute to clinical study report (CSR) development and review.
- Leadership, Innovation & Continuous Improvement
- Supervise and develop CTM staff through coaching, performance management, training, and ongoing mentorship.
- Assign work, oversee deliverables, and ensure high-quality execution across the clinical operations team.
- Champion cross-functional and departmental process improvements, driving operational excellence and standardization.
- Identify and implement innovative, global operational strategies and enhancements to CTM SOPs and clinical study execution models.
- Perform unmasked responsibilities as needed, including oversight of IP handling, unmasked TMF processes, IVRS management, and review of unmasked EDC data.
- Lead study-level lessons learned sessions and integrate improvements across future programs.
- Date: February 2026
- Self-motivated, with a strong sense of personal responsibility.
- Worked effectively in fast-paced environments.
Manager, Trial Management
Novo Nordisk Inc.
New Jersey, USA
06.2019 - 06.2023
- Clinical Trial Management & Operational Leadership
- Lead operational planning and execution of North America clinical trial performance, consistently meeting or exceeding productivity and quality expectations.
- Serve as therapeutic and operational expert, providing strategic leadership, project oversight, and team direction while cultivating strong vendor and CRO partnerships.
- Drive governance of strategic partnerships by acting as the primary liaison between internal stakeholders, CROs, and investigational sites to ensure contractual deliverables are met on time, within budget, and in compliance with SOPs, regulations, and quality standards.
- Lead high-performing Trial Management Teams (TMTs) across CTM and NACMR; represent North America at the International Study Group (ISG) to align global and regional execution.
- Establish clear project objectives and execution strategies that optimize speed, quality, and cost efficiency across assigned programs.
- Collaborate with Business Management to develop, manage, and forecast U.S. clinical trial budgets—including oversight of a portfolio exceeding $70M—ensuring alignment with corporate financial targets.
- Monitor patient recruitment and retention performance; implement targeted mitigation strategies to address enrollment challenges proactively.
- Coordinate protocol review with CTM, Clinical Medical, Regulatory (CMR), and other cross-functional stakeholders to ensure operational feasibility and scientific quality.
- Oversee U.S. site selection strategy in partnership with Lead CRAs and feasibility teams; ensure final site list aligns with overall trial strategy and geographic needs.
- Manage U.S. clinical supply activities, including label approval workflows, to ensure accuracy, regulatory compliance, and uninterrupted trial execution.
- Lead planning and content development for Investigator and Monitors Meetings, ensuring effective study start-up, engagement, and training across sites.
- Ensure timely, accurate reporting of study progress and key metrics to CTM senior leadership through presentations and written status updates.
- Support continuous improvement of guidelines, SOPs, training programs, and operational processes to strengthen organizational capabilities.
- Mentor and develop CTM staff, fostering talent growth, operational excellence, and readiness for increased responsibility.
- Quality and Risk Management:
- Develop, implement, and communicate comprehensive quality and risk management plans, ensuring seamless integration into overall monitoring and study execution strategies.
- Lead execution of study-level Audit Management Plans, coordinating activities to ensure full audit/inspection readiness across assigned programs.
- Own development of study-specific quality plans and direct proactive mitigation measures to address site performance challenges, quality issues, and protocol non-compliance.
- Date: February 2026
Clinical Site Lead
Novo Nordisk Inc.
New Jersey, USA
09.2017 - 06.2019
- Responsible for the performance of assigned sites within assigned trials in accordance with GCP, ICH guidelines, federal regulations, and SOPs.
- Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations.
- Act as primary liaison between in-house monitors, field based monitors and the Trial Manager for assigned sites.
- Closely collaborate with members within CTM and CMR Department.
- Responsible for review and approval of monitoring visit reports for assigned studies.
- Develop SSV/SIV and other training tools and training materials in support of the project for the project assigned CRAs & Develops study tools for sites and CRA use.
- Accountable for the quality of site performance for assigned trial. Responsible to collaborate with the CRA to develop any Corrective Action Plan.
- Responsible for the development and maintenance of the project Q and A documents.
- Responsible for the development of any mass site communication as appropriate.
- Review and ensure all protocol deviations are entered in collaboration with the CRAs.
- Review and provide input to the Trial Materials Manual and ensure distribution to assigned sites and project team members as appropriate (CRAs).
- Date: February 2026
Clinical Operations Manager
Novo Nordisk Egypt
Cairo, Egypt
11.2013 - 09.2017
- Fulfilled the vital responsibility of establishing a well-functioning Clinical trial department and developed a skilled team at Novo Nordisk Egypt.
- Clinical Trial Management:
- Achieved high quality by ensuring compliance to applicable regulations, guidelines, and SOPs for study activities at all levels (NN Egypt, sites and vendors).
- Identified, selected, and where required, developed potential centers for clinical research in Egypt.
- Created a database of potential investigators for affiliate.
- Developed Clinical Trial related local processes at the affiliate.
- Responsible for study start up activities at affiliate.
- Developed subject recruitment and retention strategies for centers and also for the country.
- Developed and maintained detailed timelines and resource projections for all projects.
- Budget preparation – Involved in development, management and tracking budget for clinical research activities in country. Ensured that the expenses are in line with agreed annual budget.
- Made sure that requirement of updating in IMPACT, novoDOCs, EDC, and other related systems are met.
- Developed and maintain good relationship with important stakeholders like Ministry of Health and Ethical Committees for clinical study submission.
- Part of the global trial allocation process to ensure that clinical trials allocated are appropriate for the country from regulatory and marketing point of view.
- Efficiently coordinated with cross-functional teams in affiliate and liaised between local affiliate’s management and regional office to ensure smooth running of trials.
- Resources and Team Management:
- In charge of assessment and allocation of resources. Responsible for selection and recruitment of qualified staff to build clinical research team at Novo Nordisk Egypt.
- Ensure that all team members understand and work toward corporate, department and individual goals.
- Responsible for training, development, and appraisal process for team.
- Identification of development needs based on their skills/experience and actively provided training or facilitated training for the team members.
- Vendor Management- Negotiated effectively with laboratories, insurance company, Shipping company, local depot for trial product, translation agency etc. to ensure cost reduction as well as enhancement of services.
- Managed and executed the overall project scope, budget, and timelines in coordination with clinical, medical, marketing, and regulatory teams.
- Risk Identification and Mitigation:
- Responsible for preparation of country recruitment and retention strategies as well as mitigation plan for all the projects running in affiliate.
- Date: February 2026
Local Trial Manager
Novo Nordisk India Private Ltd.
Bengaluru, India
07.2012 - 11.2013
- Responsible for the performance of assigned sites within assigned trials in accordance with GCP, ICH guidelines, federal regulations, and SOPs.
- Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations.
- Act as primary liaison between in-house monitors, field based monitors and the Trial Manager for assigned sites.
- Closely collaborate with members within CTM and CMR Department.
- Responsible for review and approval of monitoring visit reports for assigned studies.
- Develop SSV/SIV and other training tools and training materials in support of the project for the project assigned CRAs & Develops study tools for sites and CRA use.
- Accountable for the quality of site performance for assigned trial. Responsible to collaborate with the CRA to develop any Corrective Action Plan.
- Responsible for the development and maintenance of the project Q and A documents.
- Responsible for the development of any mass site communication as appropriate.
- Review and ensure all protocol deviations are entered in collaboration with the CRAs.
- Review and provide input to the Trial Materials Manual and ensure distribution to assigned sites and project team members as appropriate (CRAs).
- Date: February 2026
Clinical Research Associate
Novo Nordisk India Private Ltd.
Bengaluru, India
04.2010 - 10.2012
- Responsible for the performance of assigned sites within assigned trials in accordance with GCP, ICH guidelines, federal regulations, and SOPs.
- Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations.
- Act as primary liaison between in-house monitors, field based monitors and the Trial Manager for assigned sites.
- Closely collaborate with members within CTM and CMR Department.
- Responsible for review and approval of monitoring visit reports for assigned studies.
- Develop SSV/SIV and other training tools and training materials in support of the project for the project assigned CRAs & Develops study tools for sites and CRA use.
- Accountable for the quality of site performance for assigned trial. Responsible to collaborate with the CRA to develop any Corrective Action Plan.
- Responsible for the development and maintenance of the project Q and A documents.
- Responsible for the development of any mass site communication as appropriate.
- Review and ensure all protocol deviations are entered in collaboration with the CRAs.
- Review and provide input to the Trial Materials Manual and ensure distribution to assigned sites and project team members as appropriate (CRAs).
- Date: February 2026
Clinical Research Coordinator
KLE’s Hospital & Medical Research Centre
Belgaum, India
08.2008 - 02.2010
- Responsible for the performance of assigned sites within assigned trials in accordance with GCP, ICH guidelines, federal regulations, and SOPs.
- Responsible for operational aspects of planning and management of site performance in accordance with departmental productivity expectations.
- Act as primary liaison between in-house monitors, field based monitors and the Trial Manager for assigned sites.
- Closely collaborate with members within CTM and CMR Department.
- Responsible for review and approval of monitoring visit reports for assigned studies.
- Develop SSV/SIV and other training tools and training materials in support of the project for the project assigned CRAs & Develops study tools for sites and CRA use.
- Accountable for the quality of site performance for assigned trial. Responsible to collaborate with the CRA to develop any Corrective Action Plan.
- Responsible for the development and maintenance of the project Q and A documents.
- Responsible for the development of any mass site communication as appropriate.
- Review and ensure all protocol deviations are entered in collaboration with the CRAs.
- Review and provide input to the Trial Materials Manual and ensure distribution to assigned sites and project team members as appropriate (CRAs).
- Date: February 2026
Education
Master of Pharmacy - Pharmacy Practice
KLE’s College of Pharmacy
Belgaum, India01.2010
Bachelor of Pharmacy - undefined
Visveswarapura Institute of Pharmaceutical Sciences
Bengaluru, India01.2007
Skills
- Strong leadership skills (influencing, negotiating, assertive, taking initiative, conflict and change management)
- Proficient in verbal and written communication
- ICH GCP trained and well versed with FDA and other regulatory requirements
- Effective project management expertise
- Domain knowledge of varied therapeutic areas and regulatory/scientific guidelines
- Subject matter expert in process development and improvement
- Highly organized; meets or exceeds metrics-driven timelines within cross-functional teams
- Strive for quality results and demonstrate learning agility
- Ability to think and work independently and take initiatives
- Expertise on Clinical Trial Management systems
- Extensive experience in managing Phase 1, 2, 3, 4, and observational trials in cardiovascular, diabetes, general medicine, Haematology, infectious disease obesity and rare-disease
- Problem-solving
- Decision-making
Accomplishments
- Acted as subject matter expert on clinical research processes related to clinical trial monitoring activity, development of clinical trial analytical portal, protocol deviation reporting, site close out process, budget preparation and streamlining Investigator meeting content.
- Co-chaired departmental forums to drive continuous improvement—facilitating idea intake, prioritization, roadmap creation, and handoff to accountable teams for execution.
- Supported designing and launching of a clinical trial analytics portal that improved trial oversight and enabled proactive risk monitoring as a subject matter expert.
- Managed a 100+ site portfolio and delivered a high-impact recruitment strategy, including site engagement mapping and sourcing global/national investigators for a flagship CV outcomes trial and a rare disease program
- Led alignment with Egypt’s Ministry of Health and strengthened institutional relationships to improve clinical trial conduct and optimize submission workflows within a complex regulatory landscape.
- Successful leadership had facilitated Novo Nordisk Egypt achieve PDP approval (Qualification of country to run phase 2/3 programs).
- Establishment of Clinical centers’ database, vendor database with qualification details for Egypt.
- Supported head quarter by providing inputs in development of various projects like investigator payment project, Ethics Committee database tracking program
- Within a span of year (2014-15), established a competent clinical team, identified potential centers, developed relations with Ministry of Health, Ethics committees and vendors, conducted interventional qualification trial and IOHAT study.
- Successfully passed sponsor audit for phase 3b program without any major findings
- Awarded “Most Enthusiastic Participant” in Local Trial Manager Development workshop- 29-Jul-2013 to 31-Jul-2013 by Novo Nordisk India Pvt. Ltd.
- Awarded “Best CRA -2011” annual award by Novo Nordisk India Pvt. Ltd.
- Awarded “Best Learner -2010” award for New Hire Training Program at Novo Nordisk India Pvt. Ltd.
Timeline
Senior Clinical Study Lead
Regeneron Pharmaceuticals, Inc.
06.2023 - Current
Manager, Trial Management
Novo Nordisk Inc.
06.2019 - 06.2023
Clinical Site Lead
Novo Nordisk Inc.
09.2017 - 06.2019
Clinical Operations Manager
Novo Nordisk Egypt
11.2013 - 09.2017
Local Trial Manager
Novo Nordisk India Private Ltd.
07.2012 - 11.2013
Clinical Research Associate
Novo Nordisk India Private Ltd.
04.2010 - 10.2012
Clinical Research Coordinator
KLE’s Hospital & Medical Research Centre
08.2008 - 02.2010
Bachelor of Pharmacy - undefined
Visveswarapura Institute of Pharmaceutical Sciences
Master of Pharmacy - Pharmacy Practice
KLE’s College of Pharmacy