Swapnali Raut

About Swapnali Raut

Drug development professional with 25 years of rich clinical research strategy and operations experience across pharmaceutical companies and CROs. A team-oriented, visionary leader who has demonstrated innovation, business acumen and general management competencies with a successful track record in global end-to-end clinical trial management. Experienced in crafting strategy in a complex environment, mentoring and retaining resources and delivering results with integrity. Adept at building win-win and trust-based relationships with stakeholders across the board. Certified clinical research trainer with extensive experience in delivering clinical research methodology training in classroom and virtual setting in and outside India. A conscientious leader who respects people, appreciates diversity and values the power of collaboration. An independent thinker and quick decision maker with execution rigor. I have demonstrated continuous learning agility across varied roles. I have a genuine penchant for coaching, have mentored several professionals - making a positive impact in their career and adding to organization\'s talent pool. I take pride in the strong work ethics and value foundation that I have built while working for some of the finest organizations with thoroughbred professionals. Specialties: Clinical Program Management, Clinical trials, Clinical operations, Project Director, Clinical Research, Healthcare compliance, ICH GCP, Risk Based Monitoring, Clinical Project Management, Quality Assurance, Regulatory Submissions, Real World Evidence (RWE) projects, Clinical Research Training, Public health projects, Community based research, Customer engagement, Vaccine clinical development, Early Phase Clinical Development (EPD), First in Human studies, Biosimilar clinical development, Feasibility, Start-up.Therapy areas: Oncology, Cardiology, Endocrine and metabolic disorders, Infectious Diseases, Psychiatry etc.

Experience

1. Director, Global Clinical Operations

   GSK

   Jan 2023 — Present · Mumbai, IN

   As a Country Operations Director, I am responsible for leading and growing GlaxoSmithKline\'s Clinical Operations in Southeast Asia to deliver transformational new vaccines and medicines for patients. Leading a highly experienced and skilled team responsible for feasibility, start-up, contracting, monitoring, project management, data quality, inspection readiness, recruitment reliability, investigator payments, supporting regulatory submissions etc. Lead and/actively contribute to several GSK global workstreams.In addition to above role, I also lead a niche Clinical Matrix Team comprising of data management and project management expertise. Remit of this team is to deliver end to end on regulatory mandated clinical studies.

Education

• University of Mumbai (KMKCP)

  Masters in Pharmacy (MPharm)

  1998 — 2000

• Hibernia College, Dublin, Ireland

  MS, Masters in Pharmaceutical Medicine

  2008 — 2010

• University of Pune (PRCOP)

  Bachelors in Pharmacy, B. Pharm

  1994 — 1998

• SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

  Diploma in Business Management

  2002 — 2003

Skills

• Monitoring
• Team Building
• Clinical Research
• Project Delivery
• Training and Developement
• Quality and Compliance
• Ich-Gcp
• General Management
• Drug Development
• Risk Identification
• Team Management
• Project Management
• Clinical Operations
• Risk Mitigation
• Clinical Development
• Clinical Quality
• Customer Engagement
• Regulatory Affairs
• Project Life Cycle Management
• Clinical Monitoring