Raghunandan B

About Raghunandan B

Clinical research professional with over 17 years of experience specializing in global…

Experience

1. Principal Clinical Development (Senior Principle Supported Studies Delivery Lead)

   GSK

   Jul 2023 — Present · Bengaluru, IN

   Managed interventional and non-interventional (observational) trials, as well as registry trials, within specialty medicine.Led the successful negotiation and conclusion of legal contractual agreements with third-party vendors for investigator-led real-world evidence (RWE) trials, both interventional and non-interventional studies.Directly collaborated with stakeholders in medical LOCs at GSK (country organizations) on study start-up activities, including protocol development, review, drafting, and approval of legal contracts with external investigators and vendors. Conducted due diligence checks, confidentiality agreements, and monitored global clinical supplies for sites, study progress, and publication. This involved stakeholder management across various functions within a matrix organization such as legal, finance, medical affairs, clinical operations, safety, regulatory affairs, and clinical supplies.Presented evidence generation dashboards to global medical/scientific leads in different geographical areas, outlining study progress, regulatory processes, and identifying any bottlenecks. Involved in project management metrics including milestones management, finance accrual management, quality metrics, and timeline management using company-approved management tools.Managed budgeting processes, including reviewing itemized budget lists from third-party vendors and independent trial investigators, initiating and tracking budget proposals, and coordinating with finance/contracts teams for global fair market value assessments (FMV).Reviewed clinical protocols, informed consent forms (ICFs), quality review plans, and other study start-up documents. Led the matrix development of clinical protocols (RWE, epidemiology studies, clinical trials, database studies) through discussions and sharing inputs with global medical leads, local medical affairs, statistical teams, data management, and operations.

Education

• Alvas College, Moodabidri

  Bachelor's Degree

  2002 — 2005

• Institute of clincal Research India(ICRI)

  Master's Degree

  2005 — 2007

Skills

• Overall 7 Years Working in Clinical Research in a Sponsor and CRO, Starting as C
• Clinical Trials
• CRO
• Good Clinical Practice (Gcp)
•  Experience in Off Shore Site Monitoring and Management I.e. India, Malaysia an
• Clinical Data Management