MAYANK S CHAUDHARI
Ahmedabad
Summary
Dynamic Clinical Trial manager with a proven track record at Pharmazone excelling in regulatory compliance and clinical data management. Skilled in mentoring teams and streamlining processes, ensuring adherence to ICH-GCP and Regulatory guidelines. Demonstrates exceptional organizational abilities and problem-solving skills, significantly enhancing study efficiency and data integrity.
Overview
7
7
years of professional experience
Work History
Assistant Manager Clinical Trials
Pharmazone
Ahmedabad
11.2023 - Current
- Monitored vendor performance for outsourced activities such as laboratory services or contract research organization.
- Identified areas for improvement in existing processes and developed strategies for implementation.
- Monitored inpatient bed use, facilities and staff to provide optimal use of resources.
- Developed and implemented operational plans, processes and procedures for clinical trials.
- Tracked progress of clinical trial activities against timelines and budgets.
- Provided training on Good Clinical Practice guidelines and SOPs related to clinical trial operations.
- Prepared various reports related to the status of ongoing studies which were presented to senior management.
- Resolved any discrepancies observed during audits or inspections by regulatory authorities.
- Monitored the progress of clinical studies according to established timelines and budgets.
- Provided technical support to investigators regarding regulatory requirements related to their respective studies.
Research Executive Clinical Trials
COD Research
Ahmedabad
04.2021 - 11.2023
- Monitor sponsor-initiated and federally funded clinical trials, ensuring compliance with protocols, FDA, and ICH-GCP guidelines.
- Assist in site selection, study start-up, and creation of clinical project documents, including SOPs and monitoring templates.
- Conduct remote monitoring, assess study personnel qualifications, and perform closeout visits to ensure protocol adherence.
- Reconcile site files, ensuring document consistency and compliance with regulatory requirements and project SOPs.
- Verify data accuracy, resolve queries, and provide study status updates to team members and project management.
Officer Clinical Trials
Lambda Therapeutic Research. Ltd
Ahmedabad
04.2019 - 03.2021
- Monitor sponsor-initiated and federally funded clinical trials, ensuring compliance and subject safety.
- Assist with IRB applications, maintain correspondence, and manage adverse events, and protocol amendments.
- Recruit and enroll subjects, obtain informed consent, and maintain regulatory and source documentation.
- Train and supervise CRCs, maintain databases, and generate reports for the coordinating center.
Clinical Research Associate
Acutest Research ltd
Ahmedabad
11.2017 - 03.2019
- Monitor sponsor-initiated and federally funded clinical studies, ensuring protocol adherence and subject safety.
- Develop and maintain monitoring procedures, tools, and reports, including corrective action plans.
- Oversee the selection, training, and supervision of clinical study monitors and investigative personnel.
- Collaborate with data management and study teams to resolve enrollment issues and ensure compliance.
Education
Bachelor of Pharmacy -
Kavayitri Bahinabai Chaudhari North Maharashtra University
Jargon01.2016
Skills
- Clinical research processes
- ICH-GCP
- Patient Recruitment
- Regulatory requirements
- Clinical Data Monitoring
- Problem-solving skills
- Investigator engagement
- Manage multiple priorities
- Clinical trial management systems (CTMS)
- Training and mentoring
- Clinical data management
- Continuous improvement
- Project concepts
- Adverse event reporting
- Regulatory compliance
Hobbies and Interests
- Helping organizations obtain better brand recognition and financial growth. To coordinate with company executives and sales & marketing professionals to review current market trends in order to propose new business ideas that can improve revenue margins. To build long-standing and successful relationships with key clients.
- Horse riding
- Playing chess
- Bike riding
Projects
University level competition Avishkar, 2013, Winner All Clinical Trials Studies, Phase-I First in humans, Phase-II Determine Efficacy & Safety, Phase-III Compare new agent with Standard Treatment, Management of CLINICAL TRIALS & BABE STUDIES.
Disclaimer
I hereby declare that the particulars given herein are true and complete to the best of my knowledge and belief.
Languages
- Gujrat
- English
- Hindi
- Marathi
Personal Information
- Date of Birth: 06/09/89
- Nationality: Indian
- Marital Status: Married
Achievements And Awards
- ICH-GCP training, COD Research Limited AMA., 2021
- GCP and GLP training, Lambda Therapeutic Research Ltd., 2021
- GCP and GLP training, Pharmazone, 2025
Timeline
Assistant Manager Clinical Trials
Pharmazone
11.2023 - Current
Research Executive Clinical Trials
COD Research
04.2021 - 11.2023
Officer Clinical Trials
Lambda Therapeutic Research. Ltd
04.2019 - 03.2021
Clinical Research Associate
Acutest Research ltd
11.2017 - 03.2019
Bachelor of Pharmacy -
Kavayitri Bahinabai Chaudhari North Maharashtra University
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