Karthik H S

About Karthik H S

Clinical Research and Laboratory Operations leader with 19+ years of experience in clinical trial operations, human biological sample management, and biomarker assay workflows across global Phase trials.Currently serving as an Associate Director – Laboratory Study Management, I lead cross-functional teams responsible for end-to-end sample logistics, central lab coordination, Bioanalytical support, and regulatory compliance (GCP, ICH guidelines). My focus is on building scalable, inspection-ready systems that align scientific rigor with operational excellence. Expertise includes:Clinical trial sample operations (central labs, biobanks, logistics partners)Human Biospecimen management: plasma, serum, PBMCs, tissue, and DNABiomarker development and bioanalytical supportClinical trial vendor oversight, site engagement, and protocol developmentCAPA management, deviation tracking, and audit readiness (GCP/GLP)Collaboration with Clinical Operations, Biomarker Leads, QA, and Regulatory AffairsSOP creation, LIMS/eTMF documentation, and inspection preparednessI’ve worked across diverse therapeutic areas (oncology, immunology, metabolic disorders) and supported global sponsor–CRO ecosystems to ensure sample quality, data integrity, and timely delivery of lab results critical to clinical endpoints.With a passion for process optimization, compliance excellence, and scientific collaboration, I’m always seeking opportunities to drive innovation and efficiency in clinical development. Let’s connect if you\'re looking for someone who blends operational depth with scientific understanding to deliver high-impact results in global clinical trials.

Experience

1. Associate Director - Laboratory Study Management (Human Biological Sample Management)

   GSK

   May 2025 — Present

   Manage the operationalization of GSKs India strategy for FSP Lab Study Managers, managing onboarding, integration, and governance to scale a compliant, high-performing delivery model. • Provide strategic leadership to a team of 37+ LSMs & LSAs, driving coaching, conflict resolution, and individualized development planning to build talent and engagement. • Oversee critical process improvement initiatives including liver safety event management, manifest optimization, FSO optimization, and budget oversight, enhancing operational quality and efficiency. • Co-Lead a global task force on Central lab sample acceleration and support Gen AI-driven innovation in sample management to enable faster, data-informed decision-making. • Manage workload distribution across FSP and headcount LSMs based on study complexity and priority, ensuring balanced resourcing and on-time delivery.

Education

• SRN Adarsh College

  B.Sc, Biotechnology, Genetics, Chemistry

  2001 — 2004

• National College, Basavanagudi, Bangalore-4(Autonomous)

  PCMB

  1999 — 2001

• Madurai Kamaraj University

  M.Sc.,, Biochemical Technology

  2004 — 2006

• Vasavi educational trust

  10th

  1989 — 1999

• Indian Institute of Management Ahmedabad

  AGMP, Business Administration and Management, General

• Indian Institute of Management Ahmedabad

  AGMP, Business Administration and Management, General

  2020 — 2021

Skills

• Protein Chemistry
• Antibodies
• Molecular Biology
• Sop
• Elisa
• Chromatography
• Biotechnology
• Protein Purification
• Site-Directed Mutagenesis
• Assay Development
• Sequencing
• Laboratory
• Laboratory Skills
• Pcr
• Life Sciences
• Biochemistry
• Cell Culture
• Purification