Nihar Tanna
Ahmedabad
Summary
Qualified M. Pharm. (Pharmacology), holds a keen interest in clinical trials, regulatory affairs, R&D, and pharmacovigilance.
Skilled clinical research professional with a background in managing and overseeing clinical trials. Experience includes coordinating with research teams, ensuring compliance with protocols, and managing participant recruitment and data collection processes. Possess strong organizational skills, the ability to manage multiple tasks efficiently, and the capability to ensure accuracy in documentation and reporting. Contributed to improving trial procedures, and enhancing data integrity in previous roles.
Overview
12
12
years of professional experience
Work History
Assistant Project Manager
Lambda Therapeutic Research Pvt Ltd
Ahmedabad
01.2025 - Current
- Prepare the project plan according to the project timelines, budget, and deliverables.
- Track timelines, milestones, and budget requirements for assigned projects.
- Allocate CRAs to clinical trial projects.
- Coordinate the planning and conduct of clinical trial projects in liaison with CRAs and other interdepartmental team members.
- Provide protocol-specific training to the CRAs, including therapeutic expertise, CRF conventions, study procedures, and SOPs.
- Supervise the activities of the CRAs, including the scheduling of monitoring visits and other activities associated with the project (e.g., review of visit reports for completeness and accuracy, assisting monitors with site problems, etc., and time accountability for the project).
- Conduct quality control and co-monitoring visits with CRAs to ensure quality and compliance with SOPs, GCP, and project requirements. Assist and guide CRAs in conducting pre-study, initiation, interim, and close-out monitoring visits, as required.
- Review and approve payments to the study site and vendors.
- Monitored subject enrollment and tracked dropout details.
- Prepared presentations outlining project objectives, progress updates, results analysis. for internal stakeholders or external sponsors and investigators.
- Guide the software team in developing the e-CRF.
- Conducted periodic meetings with stakeholders to review project status and address any issues that may arise.
- Managed day-to-day operations associated with ongoing clinical research projects.
- Utilized various software and tools to streamline processes and optimize performance.
Senior Clinical Research Associate
Lambda Therapeutic Research Pvt Ltd
Ahmedabad
05.2022 - 01.2025
- QC work planning, creating a QC plan for each study, liaising with QA for sponsor system audit queries and regulatory queries/inspection findings
- To perform QC-related activities in the assigned study as per the finalized QC plan of the respective study.
- Preparation and finalization of study-related plans, manuals, logs, and forms as applicable.
- Study audit and system audit CAPA, trend analysis of QC issues across studies, phases, stages, and teams.
- Overview of all project tools and software, and tracking enhancement planning, including Excel trackers and CTM study templates,
- Deviation management (system, protocols, and plan), CAPA tracking and closure, risk identification, and mitigation.
- Discussed prerequisites to maintain team productivity for project goals and objectives.
- Performed pre-study, closeout, and interim visits to check on study activities as per the QC plan.
- Provided support to internal audit teams conducting audits at investigative sites.
- Monitored subject enrollment and tracked dropout details.
Officer
Macleods Pharmaceuticals LTD
Ahmedabad
11.2019 - 05.2022
- To perform in-process and retrospective quality checks in the clinical department. Retrospective quality checking of study documents.
- To perform quality checks in different in-process activities, such as screening, check-in, dosing, and sample separation.
- Performing site initiation visits, site monitoring visits, and close-out visits for the assigned study as per the protocol, SOPs, ICH-GCP, and regulatory requirements, and preparing the visit report.
- Monitored subject enrollment and tracked dropout details.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Reported to project manager for issues related to overall study status.
Senior Research Associate
Lambda Therapeutic Research Pvt. Ltd
Ahmedabad
10.2016 - 11.2019
- To perform quality checks in the clinical phase.
- To perform in-process and retrospective quality checks in the clinical department. Retrospective quality checking of study documents in Biznet software.
- Responses to Quality Assurance, Regulatory Affairs audit queries.
- To perform system audits.
QA Auditor (Research Associate)
Veeda Clinical Research Pvt. Ltd
Ahmedabad
11.2015 - 05.2016
- Preparing a study audit plan for BA/BE and Phase I studies, conducting study audits (in-process audits and retrospective audits) of clinical phases.
- Preparation and issuance of study audit reports (in-process and retrospective audits) for clinical phases.
- Compliance verification of study audit responses, and closure of the audit reports.
- Review of final/draft study reports.
- Issuance of QA Authentication for the Study.
Clinical Research Associate
Accutest Research Laboratories Pvt. Ltd
Ahmedabad
01.2013 - 11.2015
- To perform in-process and retrospective quality checks in the clinical department. Retrospective quality checking of study documents
- To perform quality checks in different in-process activities, such as screening, ICF presentation, check-in, dosing, vital examination, check-out, and post-study.
- To check study-related labels.
- To maintain all QC reports in file and archive them.
- Responses to quality assurance audit queries.
Education
M.pharm - Pharmacology
Department of Pharmaceutical Sciences
Rajkot07-2012
B.Pharm - Pharmacy
N.R. Vekaria Institute of Pharmacy & Research Centre
01.2010
XII -
Saurashtra University, Alpha High School, Higher Secondary Education Board
01.2006
Noble High School, Higher Secondary Education Board
01.2004
Skills
- Team building
- Friendly, positive attitude
- Regulatory compliance
- Clinical trial management
- Audit preparation
- Attention to detail
- Project planning
- Stakeholder communication
- Quality control planning
- Clinical monitoring
- Project management
Accomplishments
- ICH-GCP and Schedule Y training
- 16th National Convention of Society of Pharmacognosy and International Symposium on Herbal and Traditional Medicine
- 4th World Congress of the Academy of Cardiovascular Sciences (IACS)
- India’s prospects to becoming Drug Discovery & Pharmaceutical Innovation Hub GoI Initiatives & Your Role
- ACADEMIC PROJECT AND RESEARCH UNDERTAKEN
- Title: Experimental Evaluation of ACE Inhibitor on Gentamicin-induced Nephrotoxicity in Rats
Timeline
Assistant Project Manager
Lambda Therapeutic Research Pvt Ltd
01.2025 - Current
Senior Clinical Research Associate
Lambda Therapeutic Research Pvt Ltd
05.2022 - 01.2025
Officer
Macleods Pharmaceuticals LTD
11.2019 - 05.2022
Senior Research Associate
Lambda Therapeutic Research Pvt. Ltd
10.2016 - 11.2019
QA Auditor (Research Associate)
Veeda Clinical Research Pvt. Ltd
11.2015 - 05.2016
Clinical Research Associate
Accutest Research Laboratories Pvt. Ltd
01.2013 - 11.2015
B.Pharm - Pharmacy
N.R. Vekaria Institute of Pharmacy & Research Centre
XII -
Saurashtra University, Alpha High School, Higher Secondary Education Board
Noble High School, Higher Secondary Education Board
M.pharm - Pharmacology
Department of Pharmaceutical Sciences
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