Virag Shekhar Shah
Bangalore
Summary
Clinical Project Manager with 11+ years of experience in the Clinical Research Industry. Proven ability to successfully manage and lead clinical research projects from start to end, ensuring that all timelines, budgets, and regulatory requirements are met. Expertise in risk management, and quality assurance. Excellent written and verbal communication skills, as well as strong organizational and problem-solving abilities.
Overview
11
11
years of professional experience
Work History
Clinical Project Manager
Lotus Pharmaceuticals Limited
Bangalore
11.2022 - Current
- Developed and implemented project plans to ensure timely completion of clinical trials.
- Organized and led cross-functional teams to manage the development, execution, and reporting of clinical studies.
- Prepared budgets for each trial including resource allocation across all sites involved in the study.
- Implemented In-house monitoring policies and trained colleagues on process.
- Handling regulatory queries of various regulatory agencies as well as different cliennts.
- Managing end to end Bioequivalence studies for various regulatory submissions.
- Negotiated contracts with vendors regarding cost estimates and service levels required for successful execution of studies.
- Cost negotiation helps organization to save almost 30K USD
Assistant Manager
Ipca Laboratories Limited
Mumbai
09.2019 - 10.2022
- Handling multicentric Clinical Trials which includes;
- Site selection and communications
- EC dossier preparation and submit it to sites
- EC query resolutions
- Site Initiation Visits
- Regular Follow-up with respective sites for patients visits
- Assessment of in-vitro in-vivo data and draft a biostrategy for upcoming bioequivalence studies
- Quotation negotiation and financial communication with CRO
- Query handling for different regulatory agency's including DCGI
- Protocol/Report review and finalization according to respective regulatory requirements
- BE study monitoring
Senior Officer
Ajanta Pharma Limited
Mumbai
02.2018 - 09.2019
- Assessment of new molecule for the feasibility of bioequivalence study
- Review and finalize study protocol as per regulatory requirement
- Conduct Study Monitoring Visits to check compliance of study protocol, SOPs, Raw Data, and other regulatory requirements
- Review and finalize the complete clinical study report according to ICH guideline
- CDISC data review
Senior Scientist
Biocon Research Limited
Bangalore
07.2016 - 02.2018
- Assessment of new molecule for the feasibility of bioequivalence study
- Review and finalize study protocol as per regulatory requirement
- Conduct Study Monitoring Visits to check compliance of study protocol, SOPs, Raw Data, and other regulatory requirements
- Review and finalize the complete clinical study report according to ICH guideline
- Preparation of Clinical Overview
- Support in patient data review for the clinical trials.
Executive
Micro Labs Ltd
Bangalore
03.2013 - 07.2016
- To conduct Facility & Study Specific Audit of CRO
- Generate Audit Report with categorized findings within the timelines
- Review and finalize study protocol as per regulatory requirements
- Conduct Study Monitoring Visits to check compliance of Study Protocol, Standard Operating Procedures (SOPs), Raw Data and other regulatory requirements
- Review and uploading dossier through PharmaReady in e-CTD (Electronic Common Technical Document) format for regulatory submission
- Preparation of Clinical and Non-clinical overviews
- Preparation of Summary of Product Characteristic and Patient Information Leaflet as per regulatory requirements.
Education
B-Pharmacy - Pharmacy
R.C.Patel College of Pharmacy
North Maharashtra UniversityD-Pharmacy - Pharmacy
KES College of Pharmacy
Maharashtra State Board Of Technical EducationM-Pharmacy - Clinical Pharmacy
R.C.Patel College of Pharmacy
North Maharashtra University08-2012
Skills
- Project Management
- Stakeholder Communication
- Clinical trials
- Medical Writing
- Query Handling
- Bioequivalence studies
- Compliance With Regulatory Guidelines
- Patient Safety
- Proficient in MS office
Languages
Gujarati
First Language
English
Proficient (C2)
C2
Marathi
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
References
References available upon request.
Timeline
Clinical Project Manager
Lotus Pharmaceuticals Limited
11.2022 - Current
Assistant Manager
Ipca Laboratories Limited
09.2019 - 10.2022
Senior Officer
Ajanta Pharma Limited
02.2018 - 09.2019
Senior Scientist
Biocon Research Limited
07.2016 - 02.2018
Executive
Micro Labs Ltd
03.2013 - 07.2016
B-Pharmacy - Pharmacy
R.C.Patel College of Pharmacy
D-Pharmacy - Pharmacy
KES College of Pharmacy
M-Pharmacy - Clinical Pharmacy
R.C.Patel College of Pharmacy
Similar Profiles
Vani ShreeVani Shree
Quality Assurance Analyst at Lotus Labs Private Limited (Client: Teva Pharmaceuticals)Quality Assurance Analyst at Lotus Labs Private Limited (Client: Teva Pharmaceuticals)
Jaya Krishna RayarothJaya Krishna Rayaroth
Project Manager – Clinical Pharmacology at Meishi (Lotus)PharmaceuticalsProject Manager – Clinical Pharmacology at Meishi (Lotus)Pharmaceuticals
SOLOMON OLAWUMI ABIOLASOLOMON OLAWUMI ABIOLA
Legal And Company Secretariat Assistant at LOTUS BANK LIMITEDLegal And Company Secretariat Assistant at LOTUS BANK LIMITED