Swetapadma Padhy

About Swetapadma Padhy

I bring over 10 years of experience in Clinical Operations, overseeing global Phase trials across oncology, hematology, gene therapy, and rare diseases. My work centers on driving high‑quality clinical execution—facilitating cross‑functional alignment, guiding Study Execution Teams, and ensuring study milestones are delivered with precision and compliance.I manage complex operational activities including protocol and ICF development, study metrics oversight, risk identification and mitigation, and vendor and CRO coordination. My approach emphasizes proactive issue resolution, strong scientific and operational judgment, and consistent inspection‑ready standards across all phases of study delivery.My focus is advancing impactful clinical research in hematologic oncology, gene therapy, and rare disease. With a proven record of managing global studies, optimizing vendor performance, and strengthening cross‑functional collaboration, I am committed to operational excellence and meaningful contributions to innovative therapeutic development.

Experience

1. Study Manager

   BioMarin Pharmaceutical Inc.

   Jan 2023 — Present

   Overall study execution oversight- Provide leadership, guidance, and direction to clinical operation staff assigned to studies-Collaborate with cross-functional study members to drive and execute on study deliverables, documents,and plans. Facilitate cross-functional Study Execution Team meetings-Proactively identify, manage, and communicate cross functional study issues, risks, and mitigations in a timely manner- Provide regular study quality and progress updates to key stakeholders as needed-Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate-Collaborate with People and Process Managers of the Study Specialist staff to support team member productivity and career growth. Other responsibilities Include-Contribute to the Study protocol and Informed Consent Form (ICF) development-Management of Study Timelines -Management of CRO for EU, EMEA and APAC region including Japan and Vendors -Management of Study Lifecycle (start-up, enrollment, maintenance, and close-out)-Oversight of Drug / Investigational Product (IP) process -Management of Study Budget -Oversight of Feasibility, Recruitment and Enrollment -Oversight of Study Outcome and Data Deliverables

Education

• V.M.K.V College of Engineering, , Vinayaka Missions University

  BS, Biotechnology

• University of California, Santa Cruz

  Clinical Trials Design and Management, Medical/Clinical Assistant

• GITAM University

  MS, Biotechnology

Skills

• Dna Extraction
• Polymerase Chain Reaction (Pcr)
• Pcr
• Gel Electrophoresis
• Spectrophotometry
• Genetic Engineering
• Dissolution
• Hplc
• High-Performance Liquid Chromatography (Hplc)
• Genetics
• Dna Sequencing
• Purification
• Molecular Biology
• Sds-Page
• Microsoft Office
• Elisa