Arati Kanchi
MD, Medical Director at Amgen
- Role
- Medical Director at Amgen
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Arati Kanchi
Over 9 years of pharmaceutical industry-sponsored clinical trial management progressive experience *Global multi-site clinical trial management experience *Phase I, II and IV clinical trial management expertise*Conduct of study from start-up to close out in accordance with SOPs, ICH-GCP, regulatory guidelines*CRO management, Vendor management, and direct site management experience*Expertise in Oncology, Diabetes, Cardiovascular and infectious diseases therapeutic areas*Proficiency in preparing and reviewing regulatory documents (ICF, protocol, product manual), SOPs, study reports*Preparing Contracts and budgets*Data monitoring, data listing and Electronic Data Capture (EDC) management*Institutional Review Board (IRB) submission and IRB communication*San Francisco Bay Area startup experience (sponsors) and global CRO experience*International medical graduate (MD) having a bachelor\'s degree in Medicine and Surgery (MBBS) from one of the top 10 medical schools in India*Strengths include experience as a physician, formal education in clinical research and pharmacology with an excellent understanding of drugs in terms of mechanism of action, route of administration, dosage and adverse effects*Computer skills: Microsoft Office, Word, Excel, and PowerPoint, well versed with both MAC & Windows*Excellent verbal, written communication, presentation, analytical skills
Experience
Medical Director
Oct 2023 — Present · US
Education
Stanford University School of Medicine
Epidemiology and Clinical Research
2018 — 2019
Maharashtra University of Health Sciences
MD, Medicine & Surgery, MBBS
Skills
- Ich Guidelines
- Bioavailability
- Clinical Trial Analysis
- U.s. Food and Drug Administration (Fda)
- Medicine
- Anvisa
- Standard Operating Procedure (Sop)
- Bioequivalence
- Clinical Research Experience
- Clinical Research
- Gynecologic Surgery
- Patient Counseling
- Protocol
- Informed Consent
- Clinical Monitoring
- Subject Recruitment
- Good Clinical Practice (Gcp)
- Clinical Trials
- Pharmaceutical Industry
- Ich-Gcp
- Ecg Interpretation
- Regulatory Compliance
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