プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

Gokul P.に依頼

India

Clinical Development, Clinical Research Scientist, Clinical Data Management & Analysis, Trends & Insights, 14+ yrs exp

プロフィール概要

An accomplished leader with 14 years of extensive experience in clinical development and medical affairs. Expertise encompasses managing large global teams, driving process improvements, and fostering talent development to achieve performance excellence. Proven track record in operational study oversight, high-quality clinical data review, and regulatory compliance, demonstrating strong analytical skills and strategic decision-making capabilities. Adept at building relationships with healthcare professionals and conducting training programs to enhance team expertise. Committed to cultivating an environment that promotes both personal and organizational growth, while delivering innovative solutions in the pharmaceutical industry.

専門分野

• ★ Clinical Trial Design
• ★ Clinical Data Management
• ★ Clinical Trials Data Analysis
• ☆ Biostatistics
• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Clinical Pharmacy
• ☆ Drug Development
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Preclinical Research
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Drug Efficacy Testing
• ☆ Vaccine Development
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Patient Recruitment
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Ophthalmology
• ☆ Neuro-Ophthalmology
• ☆ Regulatory Affairs
• ☆ Immunotherapy
• ☆ Gene Therapy

サービス

• Writing
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Image Analysis, Data Visualization, Data Mining, Data Cleaning, Data Processing, Data Insights

Product Development Product Evaluation, Quality Assurance & Control (QA/QC), Concept Development, Product Launch Support

職務経験

Group Head - Clinical Scientific Experts

Novartis Healthcare Pvt. Ltd.

5月 2024 - 5月 2025

Clinical Scintific Expert-2

Novartis Healthcare Pvt. Ltd.

4月 2020 - 4月 2024

Clinical Scintific Expert-1

Novartis Healthcare Pvt. Ltd.

4月 2017 - 3月 2020

Medical Scientific Liaison

Novartis Healthcare Pvt. Ltd.

5月 2015 - 3月 2017

Medical Scientific Liaison

Novartis Healthcare Pvt. Ltd.

6月 2013 - 12月 2014

lecturer

SGT Medical College and University

7月 2012 - 5月 2013

Senior Resident

Dr. Rajendra Prasad Government Medical College

1月 2012 - 7月 2012

lecturer

Father Muller's Medical College

3月 2011 - 12月 2011

学歴

M.Sc Medical Pharmacology

Kasturba Medical College (Manipal University)

9月 2007 - 2月 2011

B.Sc.

Acharya Nagarjuna University

6月 2004 - 3月 2007

認定資格

• HMX Fundamentals/Pro online certificate program - Immunology - Immuno-oncology

  Harvard medical school

  1月 2022 - 3月 2022