Minesh Patel
Clinical Research professional
Burr Ridge,IL
Summary
- Aspiring Medical graduate and Clinical Research professional having more than 15 years of extensive project experience from concept to development.
- Talents include in-depth knowledge of ICH-GCP guidelines, SAE reporting , Medical review.
- Experienced investigator in terms of handling sponsor monitoring (SQV, SIV and SCV) and Regulatory audits.
- Team leader who have excellent problem solving and good communication skills; fluent in English.
Overview
20
20
years of professional experience
6
6
years of post-secondary education
Work History
General Manager, Early Phase Clinical Operations
Cliantha Research Limited
04.2024 - Current
- Handling Sponsor monitoring (SQV, SIV, SCV)
- Assist in Regulatory Inspections like USFDA, MHRA, ANVISA, WHO, NPRA, CDSCO
- Team leader and mentor for site coordinators, TMF specialist, Investigators and physicians
- Performing role as a Principal Investigator in clinical operations in early phase studies like Phase 1 biosimilars, topical, Inhalation and oral products
- As a Medical Physician reviewing protocols, Medical screening reports, CAPA responses to Audit report and preparation review of clinical study report (eCTD)
Assistant General Manager
Cliantha Research Limited
04.2022 - 03.2024
- Handling Sponsor monitoring (SQV, SIV, SCV)
- Assist in Regulatory Inspection like USFDA, MHRA, ANVISA, WHO, NPRA, CDSCO
- Team leader and mentor for site coordinators, TMF specialist, ,Investigators and physicians
- Performing role as a Principal Investigator in clinical operations in early phase studies like Phase 1 biosimilars, topical, Inhalation and oral products
- As a Medical Physician reviewing protocols, Medical screening reports, CAPA response to Audit report, review and preparation clinical study report
Senior Manager- Early Phase Clinical Operations
Cliantha Research Limited
04.2019 - 03.2022
- Team leader and mentor for site coordinators, TMF specialist, Investigators and physicians
- Performing role as a Principal Investigator in clinical operations in early phase studies like Phase 1 biosimilars, topical, Inhalation and oral products
- As a Medical Physician reviewing protocols, Medical screening reports, CAPA response to Audit report and preparation clinical study report
- Handling sponsor monitoring (SDV)
Investigator- Early Phase Clinical Operations
Cliantha Research Limited
06.2015 - 03.2019
- Performing role as a Principal Investigator and having overall responsible for right, safety and well being of subjects in early phase studies like Phase 1 biosimilars, topical, Inhalation and oral products
- As a Medical Physician reviewing protocols, Medical screening reports and study data
- AE/SAE reporting, Causality Assessment
- Source data entry (EDC)
Drug Safety Physician, Medical Reviewer
Tata Consultancy Services
02.2014 - 05.2015
- Provide medical oversight and completion of analysis of serious adverse events (ARISg)
- Company causality assessment, and expectedness assessment,
- Review of MedDRA coding
- Signal detection and risk management Pharmacovigilance oversight for assigned projects.
Investigator
Cliantha Research Limited
07.2012 - 02.2014
- Screening of heathy volunteers and review of medical screening records
- Informed consent process
- AE management
- Subject safety and well being
Research Associate (A-M)
Torrent Pharmaceuticals Limited
10.2009 - 03.2012
- Screening of heathy volunteers and review of medical screening records
- Informed consent process
- AE management
- Subject safety and well being
Clinical Research Manager
Shalby Hospitals
05.2009 - 10.2009
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Complied with research protocols by providing ongoing quality control audits.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Followed informed consent processes and maintained records.
Medical Officer
Apollo International Hospital
04.2007 - 12.2007
- Assisted senior physicians and surgeons during assessments, examinations and surgical interventions.
- Manage all aspects related to patient care within their departments and provide support to nursing staff.
- Maintain treatment records
- Assisted emergency medical operation in consultation with Head - Emergency medical services
Medical Officer
HCG Medisurge Hospital
10.2004 - 12.2005
- Assisted senior physicians and surgeons during assessments, examinations and surgical interventions.
- Manage all aspects related to patient care within their departments and provide support to nursing staff.
- Maintain treatment records
Education
M.Sc. - Clinical Research
Cranfield University - ICRI
Ahmedabad, India08-2009
Bachelor of Medicine And Bachelor of Surgery -
B. J. Medical College
Ahmedabad, India 12.1998 - 10.2004
Technical skills
- Clinical Trial Knowledge and GCP Expertise
- Site Monitoring and Management.
- Regulatory Compliance and Ethics.
- Data Verification and Quality Assurance.
- AE/SAE Data Oversight
- Pharmacovigilance Compliance
- Microsoft Office Proficiency
Soft skills
- Data analysis
- Detail oriented
- Critical thinking
- Operations management
- Team leadership
- Training and development
- Conflict resolution
Hobbies
- Travel
- Reading
- Music
Timeline
General Manager, Early Phase Clinical Operations
Cliantha Research Limited
04.2024 - Current
Assistant General Manager
Cliantha Research Limited
04.2022 - 03.2024
Senior Manager- Early Phase Clinical Operations
Cliantha Research Limited
04.2019 - 03.2022
Investigator- Early Phase Clinical Operations
Cliantha Research Limited
06.2015 - 03.2019
Drug Safety Physician, Medical Reviewer
Tata Consultancy Services
02.2014 - 05.2015
Investigator
Cliantha Research Limited
07.2012 - 02.2014
Research Associate (A-M)
Torrent Pharmaceuticals Limited
10.2009 - 03.2012
Clinical Research Manager
Shalby Hospitals
05.2009 - 10.2009
Medical Officer
Apollo International Hospital
04.2007 - 12.2007
Medical Officer
HCG Medisurge Hospital
10.2004 - 12.2005
Bachelor of Medicine And Bachelor of Surgery -
B. J. Medical College
12.1998 - 10.2004
M.Sc. - Clinical Research
Cranfield University - ICRI
Skills
Technical Skills
- Clinical Trial Knowledge and GCP Expertise
- Site Monitoring and Management
- Regulatory Compliance and Ethics
- Data Verification and Quality Assurance
- AE/SAE Data Oversight
- Pharmacovigilance Compliance
- Microsoft Office Proficiency
Soft skills
- Data analysis
- Detail oriented
- Critical thinking
- Operations management
- Team leadership
- Training and development
- Conflict resolution
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Certification
Post gradation Diploma in Clinical Research
BLS/ACLS
ICH GCP
Work Preference
Work Type
Full TimeWork Location
On-SiteRemoteHybridImportant To Me
Career advancementCompany CultureHealthcare benefits401k matchTeam Building / Company RetreatsLanguages
English
Bilingual or Proficient (C2)
Software
Microsoft office
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