Dinesh Garg

About Dinesh Garg

Currently working as Associate Director - Global Trial Management with more than 16 years of experience in managing global clinical trials including more than 8 years of experience in clinicaltrial management and resource management along with set-up of new processes to achieve the excellence. I have experienced in all aspects of trial execution, including feasibility, study start-up, study conduct and study closure, as well as process development and budget management.Most recently worked as the Head of Clinical Trials for Raptim Research Pvt. Ltd. where i was responsible for managing the clinical trial department. In this role, I managed a team of project managers and other support functions including Medical Writing to execute all Phase I through trials as well as Phase IV/PMS/RWE studies. Worked as a Sr. Manager/Manager – Clinical development in TEVA Pharm Pvt. Ltd, managing all global clinical trials (Phase II, Phase and Patient based PK study) and resource management. Managed all the trial level activities starting from set up to completion which includes Planning, Allocation, Set up of study, Preparation of document and regulatory approval, Set up of other supporting department process (DM, MW, Regulatory, QA), Budgeting of trials, Set up of vendors required, Trial Initiation phase, Recruitment phase, Close out phase, Coordinating with DM and MW team for data review and CSR release, Setting up the process to develop the department and managing the resources of clinical trial department including hiring, appraisal and training of the resources. Worked as Project Manager, Clinical Trials in Macleods Pharmaceuticals Ltd. managing all clinical trails as well as resource management. Worked as CTM (Global Visit Report Approval) in ICON Clinical Research Pvt. Ltd. managing all global clinical trails. Worked as a Assistant Manager-Clinical Research/ Lead CRA/ Sr. CRA/ CRA in Novartis Healthcare Pvt. Ltd. managing all global trials. I have cleared US FDA Site Inspection as a Monitor with No Major/Critical observation for the long term (5 years) mega Novartis study.

Experience

1. Associate Director- Global Trial Management

   Bristol Myers Squibb

   Apr 2024 — Present · Hyderabad, IN

Education

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

  M.Pharma (Pharmacology), Pharmacology

  2006 — 2008

• Rajiv Gandhi Prodyogiki Vishwavidyalaya

  B.Pharma, Pharmacy

  2002 — 2005

• Rajiv Gandhi Prodyogiki Vishwavidyalaya

  D.Pharma, Pharmacy

  2000 — 2002

Skills

• Pharmaceutical Research
• Clinical Development
• Pharmacokinetics
• Ich-Gcp
• Patient Recruitment
• Clinical Trials
• Pharmaceutical Industry
• Sop
• Clinical Monitoring
• Regulatory Submissions
• Oncology
• Edc
• Oracle Clinical
• Anda
• Pharmacology
• Ctms
• Drug Development
• Standard Operating Procedure (Sop)
• Gcp
• CRO