プロフィール詳細

プロジェクトを作成

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Mayur B.に依頼

India

Freelance Clinical Study Project Management 6 + years of experience in clinical research

プロフィール概要

I am a dedicated and experienced freelancer specializing in Clinical Research. With a passion for Clinical study management, i have 6 + years of expertise in Clinical Research. Throughout my career, I have successfully completed 11 + projects (Phase III, IV and II) for reputed pharmaceutical industries . My experience includes Data Management, Clinical Trial Management, Ethical Conduct, Regulatory Compliance, Quality Management, which I apply to deliver high-quality results and meet project objectives effectively. THERAPEUTIC AREAS WORKED IN:  Cardiology  Oncology  Gynecology  Endocrinology  Neurology  Gastroenterology Special Project: Ayurcoro 3 Project (AYUSH Ministry Collaboration Project) Job responsibilities performed as Project Associate. • Preparing agenda and minutes for the meeting. • Providing assistance to the Biomedical Team in designing the Study Protocols. • Creating a trail of Documentation required for the Submission to the Regulatory Authorities. • Assisting the senior doctors in writing the treatment regimens for the patients, as per evidence-based research. • Preparing Budget sheet required for the conducting of the study. • Presenting the study in front of Hospital Board of Directors for approval of the designed study and required Budget. • As a study coordinator, conducting the Study under the Ayurveda Department. • Training my team in scheduling the patient visits, conducting the Blood and Radiology Investigation, maintaining the documentation part etc. • Under me I have been training 3 members for various projects that are assigned to me.

専門分野

• ★ Clinical Trial Design
• ★ Clinical Data Management
• ★ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Patient Recruitment
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Regulatory Affairs

サービス

• Writing
• Research

Writing Clinical Trial Documentation, Translation

Research Feasibility Study

職務経験

Project Manager/Coordinator

Hector Research & Archival Pvt Ltd

2月 2024 - 現在

Clinical Research Co-Ordinator

Bhaktivedanta Hospital and Research Institute

7月 2020 - 12月 2023

学歴

MBA Hospital and Health care management

D Y Patil University Mumbai

5月 2022 - 現在

B Pharmacy

SNJB College of pharamcy

6月 2014 - 7月 2018

認定資格

• ICH GCP

  NIDA GCP

  https://gcp.nidatraining.org/certification

  9月 2023 - 現在

出版物

JOURNAL ARTICLE

Ajay Prabhakar Sankhe, Nanasaheb Somnath Memane, Vijaykumar P. Gawali, Sonal Nanasaheb Memane, Ganesh Ramakrishnan, Tapanendu Kundu, Mayur Nimba Bagul, Ashotosh Kumar, Vikram Bansal, Rashmi Tiwari (2022). A randomized, controlled, blinded, parallel group, clinical trial to study the role of Ayurcov (AyurCoro3), one day regimen as an adjuvant therapy for COVID-19 disease management, at dedicated Covid Hospital (DCH) in India . Complementary Therapies in Medicine.

Memane N, Bagul MN, Ramakrishnan G, Sankhe A. Use of “AyurCoro-3” as a prophylactic drug in frontline healthcare workers involved in treating COVID-19 patients: A pilot study. International Journal. 2021 Jul;4(4):821 .