Soumya Gupta

Led Clinical Study Managers (CSMs) in executing trial plans and strategizing to address challenges during implementation.

• Prepare the Clinical Development Plan (CDP) for allocated products. Planning & designing the clinical studies for allocated projects in local & global CROs.
• Managed product lifecycle from concept through launch phases.
• Evaluated new molecules for R&D portfolio and determined budgetary and clinical feasibility for global market scopes.
• Lead for clinical procurement activities of Clinical Department at Sandoz Development Centre. Responsible for CRO onboarding into Sandoz system.
• Functional Quality Lead for Clinical Department. Responsible for onboarding of all new ESPs and mentoring them to integrate seamlessly within Sandoz process.
• Led training initiatives for the clinical department, assessed training needs for the entire clinical function, and reported on global KPIs.
• Conducted technical audits and facilitated onboarding of CROs both locally and globally to ensure their operational readiness.
• Clinical Lead for POD within Sandoz in AGILE framework project team.
• Facilitated stakeholder meetings to align on project goals and ensure clarity in expectations.

• Core team member for submission and filing of 'New Drug Applications'(NDAs) to the USFDA.
• Plan and manage the human, material, system and fiscal resources for clinical project delivery for both Late Phase (II/ III) & Early Phase (I) clinical development studies.
• Designing, planning and management of 'First in Human' pharmacokinetic studies.
• Instituted audits of CROs for periodic renewal and identified & selected potential CROs in India and other countries to meet portfolio pipeline needs.
• Reviewing pharmacokinetic data & interpretation of the same in order to further contribute to the product development process.
• Acted as the single point functional contact for all clinical operations and project-related details, facilitating seamless communication and coordination.
• Served as the primary contact for clinical operations and management of outsourced studies at national and international CROs.

• Focus on the conduct of clinical study with respect to GCP quality aspects and following the global quality modules of Novartis & Sandoz; up to the level of acceptance from International Health Authorities (e.g. USFDA, EMA, UKMHRA, TPD, TGA, PMDA, ANVISA, etc.).
• Reviewed and prepared bioequivalence study protocols and informed consent documents (ICD) for submission to highly regulated markets, ensuring compliance with regulatory standards.
• Monitored outsourced clinical studies at leading Indian CROs to ensure adherence to GCP quality standards and regulatory requirements.
• Resolved regulatory queries from various authorities regarding submitted bioequivalence studies, facilitating timely approvals.
• Review & design of Case Report Forms (CRFs).
• Review of literature and interpret statistical data for the designing and planning of clinical studies.
• Review of integrated clinical and statistical reports of trials.
• Review and interpretation of clinical study results.
• Participated in selecting new CROs through evaluation and comparison of proposals.

• Prepared bioequivalence study protocols and designed bioequivalence studies for drug submissions in highly regulated markets.

• Conducted literature searches and evaluated feasibility of new drug molecules and formulations for late-phase clinical trials and Phase I studies, supporting development and submission to regulated markets globally.