Nilesh Kshirsagar

Experience

• 

  Glenmark Pharmaceuticals

  May 2013 - Dec 2015

  Clinical Trial Assistant

  Support the study CRAs and CPM in successful execution of the project.

• 

  MACLEODS PHARMACEUTICALS LTD.

  Jan 2016 - May 2017

  Clinical Research Associate

  * Ensure that all assigned studies comply with organizational/applicable SOPs, GCP, and local regulations.* Identification and selection of investigators, EC submission of selected investigators for the assigned studies.* Conduct site qualification, initiation, monitoring, and close-out visits in coordination with the project manager and prepare site visit reports [Selection, Initiation, Monitoring, Closeout] according to the clinical monitoring plan timelines.* Assess the recruitment pace and suggest alternative solutions if the predefined objectives are not met in terms of patient numbers or timelines.* Address issues that impact clinical plan timelines and quality to ensure site-level goals and objectives are achieved.* Aid project managers in preparing and submitting regulatory documents.* Provide oversight of all study-related activities in coordination with the project manager.* Offer in-house project support to project team members for all trial-related activities.* Coordinate with vendors such as courier services, translation agencies, printing agencies, and central pathology laboratories.* Communicate effectively with all stakeholders.Attend study meetings/telecons and investigator meetings and prepare meeting minutes.* Maintain, review, and update in-house trial-related files and study-specific trackers. Show less

• 

  SIRO Clinpharm Pvt. Ltd.

  May 2017 - Dec 2017

  Clinical Research Associate

  * Ensure that all assigned studies comply with organizational/applicable SOPs, GCP, and local regulations.* Identification and selection of investigators, EC submission of selected investigators for the assigned studies.* Conduct site qualification, initiation, monitoring, and close-out visits in coordination with the project manager and prepare site visit reports [Selection, Initiation, Monitoring, Closeout] according to the clinical monitoring plan timelines.* Assess the recruitment pace and suggest alternative solutions if the predefined objectives are not met in terms of patient numbers or timelines.* Address issues that impact clinical plan timelines and quality to ensure site-level goals and objectives are achieved.* Aid project managers in preparing and submitting regulatory documents.* Provide oversight of all study-related activities in coordination with the project manager.* Offer in-house project support to project team members for all trial-related activities.* Coordinate with vendors such as courier services, translation agencies, printing agencies, and central pathology laboratories.* Communicate effectively with all stakeholders.Attend study meetings/telecons and investigator meetings and prepare meeting minutes.* Maintain, review, and update in-house trial-related files and study-specific trackers. Show less

• 

  Tech Observer

  Feb 2018 - now

  • Proactively manage project-level operational aspects of Clinical Trial Team (CTT) including management of trial timeline, budget, resources and vendors.• Provide efficient updates on trial progress to the Senior Manager and/or Head of Clinical Operations, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.• Ensure effective project plans are in place and operational for each trial and work proactively with the Clinical Trial Team (CTT) to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.• Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.• Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner.• Ensure all project-level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures. Show less * Support the Project Manager (PM) or Assistant Project Manager (APM) in creating accurate study status reports for assigned studies on time.* Aid Clinical Project Managers (CPMs) and project teams in gathering and organizing essential documents needed during site selection, initiation, monitoring, and close-out activities.* Manage Trial Master File (TMF), review Investigator Site File (ISF), and other regulatory documents regularly in accordance with Tech Observer/Sponsor SOPs, GCP, and local regulatory requirements.* Evaluate recruitment pace and suggest alternative solutions if recruitment goals are not met in terms of patient numbers or timelines. Also, helps in developing recruitment strategies and motivates investigators to achieve recruitment targets.* Assist in creating study tools, and training materials, and ensuring compliance with standard processes, policies, and procedures.* Support the Project Manager in devising study management plans and creating tools to track project performance.* Coordinate with various vendors such as IP Vendors, Storage Vendors, courier services, translation agencies, printing agencies, central pathology laboratory, etc.* Communicate study progress and relevant information to the PM/APM and other project team members.* Ensure the overall success of the assigned clinical operations and monitoring projects.* Ensure proper archiving of study documents at sites and with Tech Observer as per SOPs, GCP, and local regulatory regulations.* Identify and initiate budget-related discussions and recruit investigators in compliance with SOPs, GCP, and local regulatory regulations.* Handle other responsibilities delegated by the reporting Head or management. Show less * Ensure that all assigned studies comply with organizational/applicable SOPs, GCP, and local regulations.* Identification and selection of investigators, EC submission of selected investigators for the assigned studies.* Conduct site qualification, initiation, monitoring, and close-out visits in coordination with the project manager and prepare site visit reports [Selection, Initiation, Monitoring, Closeout] according to the clinical monitoring plan timelines.* Assess the recruitment pace and suggest alternative solutions if the predefined objectives are not met in terms of patient numbers or timelines.* Address issues that impact clinical plan timelines and quality to ensure site-level goals and objectives are achieved.* Aid project managers in preparing and submitting regulatory documents.* Provide oversight of all study-related activities in coordination with the project manager.* Offer in-house project support to project team members for all trial-related activities.* Coordinate with vendors such as courier services, translation agencies, printing agencies, and central pathology laboratories.* Communicate effectively with all stakeholders.Attend study meetings/telecons and investigator meetings and prepare meeting minutes.* Maintain, review, and update in-house trial-related files and study-specific trackers. Show less

  • Clinical Project Manager

    Mar 2025 - now

  • Assistant Project Manager

    Sept 2022 - Feb 2025

  • Senior Clinical Research Associate

    Feb 2021 - Aug 2022

  • Clinical Research Associate

    Feb 2018 - Jan 2021