Experience

JSS Medical Research

• Canada
• Biotechnology Research
• 300 - 400 Employee

• Senior Project Manager

  • Nov 2022 - Present

  ✓ Locate and select clinical investigators appropriate to the therapeutic area and phase of the study.✓ Assess potential study site’s to ensure the facility, staff and patient population are sufficient for study conduct, negotiate the study budget (grant) and any other contract agreements required by the Sponsor/CRO, if required, Plan or assist in conducting study start-up meetings, meet with Clinical Investigators and their staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, confirm the appropriateness of the IRB and ensure that all documentation required to initiate the study is complete.✓ At study Completion: Ensure collection of all data and remaining study supplies for return to the Sponsor/CRO, ensure that appropriate study documents are complete and properly filed in eTMF, Prepare the site for possible FDA inspection, Assist the Sponsor/CRO in problem solving and provide consultation on monitoring and study related activities.✓ Monitor and track patient enrollment and study progress, perform site audits to include source document review, Review reports & communicate to sponsor within the specified timelines✓ The position also involves: Coordinating with vendors as applicable for the study, coordinating with the PIs for site contracts, Ensuring Clinical Trial Material compliance if applicable,✓ Providing timely updates to the sponsor, to strategize for timely enrollment, Ensuring the study is completed within budgeted timelines and resources, Tracking the enrollment and retention of subjects at each site, Supervising a team of CRAs. Show less

• Project Manager

  • Jan 2021 - Oct 2022

  ✓ Locate and select clinical investigators appropriate to the therapeutic area and phase of the study.✓ Assess potential study site’s to ensure the facility, staff and patient population are sufficient for study conduct, negotiate the study budget (grant) and any other contract agreements required by the Sponsor/CRO, if required, Plan or assist in conducting study start-up meetings, meet with Clinical Investigators and their staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, confirm the appropriateness of the IRB and ensure that all documentation required to initiate the study is complete.✓ At study Completion: Ensure collection of all data and remaining study supplies for return to the Sponsor/CRO, ensure that appropriate study documents are complete and properly filed in eTMF, Prepare the site for possible FDA inspection, Assist the Sponsor/CRO in problem solving and provide consultation on monitoring and study related activities.✓ Monitor and track patient enrollment and study progress, perform site audits to include source document review, Review reports & communicate to sponsor within the specified timelines✓ The position also involves: Coordinating with vendors as applicable for the study, coordinating with the PIs for site contracts, Ensuring Clinical Trial Material compliance if applicable,✓ Providing timely updates to the sponsor, to strategize for timely enrollment, Ensuring the study is completed within budgeted timelines and resources, Tracking the enrollment and retention of subjects at each site, Supervising a team of CRAs. Show less

• Assistant Project Manager

  • Apr 2020 - Dec 2020

  ✓ Assess potential study site’s to ensure the facility, staff and patient population are sufficient for study conduct, negotiate the study budget (grant) and any other contract agreements required by the Sponsor/CRO, if required, Plan or assist in conducting study start-up meetings, meet with Clinical Investigators and their staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, confirm the appropriateness of the IRB and ensure that all documentation required to initiate the study is complete.✓ Monitor and track patient enrollment and study progress, perform site audits to include source document review, Review reports & communicate to sponsor within the specified timelines✓ At study Completion: Ensure collection of all data and remaining study supplies for return to the Sponsor/CRO, ensure that appropriate study documents are complete and properly filed in eTMF, Prepare the site for possible FDA inspection, Assist the Sponsor/CRO in problem solving and provide consultation on monitoring and study related activities.✓ The position also involves: Coordinating with vendors as applicable for the study, coordinating with the PIs for site contracts, Ensuring Clinical Trial Material compliance if applicable,✓ Providing timely updates to the sponsor, to strategize for timely enrollment, Ensuring the study is completed within budgeted timelines and resources, Tracking the enrollment and retention of subjects at each site, Supervising a team of CRAs. Show less

• Clinical Research Associate

  • Sep 2018 - Apr 2020

  Oversees operational components of clinical trials at each of clinical sites • Experienced in Oncology trials• Develops and maintains the onsite Trial Master File (TMF), in coordination with the site CRC, for each of the sites • Engages sites for patient enrolment to ensure recruitment is on time • Participates in Investigator’s Meetings • Implements clinical trial operational plans and ensures that clinical trials are conducted in a timely fashion and site is compliant with SOPs, GCP, and regulatory guidelines• Participates in patient identification activities and the development of patient recruitment plans and back-up plans• Identifies, recruits, and approves clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership• Interacts with different vendors associated with the clinical trial • Reviews invoices from sites for accuracy compared to budgets and Clinical Trial Agreement (CTA) • Ensures that all monitoring activities and processes are complete, including training of site personnel Capable of interacting effectively with scientists and managers within the organization as well as with CRCs (Clinical Research Coordinators), PIs and Co-PIs at clinical sites• Efficient in monitoring clinical data both remotely and on site visit • Strong understanding of GCP, CFR and ICH guidelines with good understanding of the regulatory (e.g., DCGI, FDA) auditing process• Knowledge and qualification with international standards (e.g. GCP, CDISC, etc.), company tools (including data management systems), processes and SOPs• Experience in managing meetings with the clinical trial teams, experts,investigators etc) Show less



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Central Clinical Monitor

  • Dec 2016 - Aug 2018

  Centralized/ Remote monitoring of clinical sites, overseeing site status from site initiation to closeout. Managing all project related deliverables like Missing pages, Query resolution, trigger management, Action items creation and resolution, SUSAR's, study trackers, access management. Working closely with data management team, discrepancy management, SAE reconciliation, PI eCRF signatures completion, IWRS/PHT/EDC reconciliations, 3rd party Vendor reconciliations & data base locks. Establish and maintain effective project/ site communications. Maintained consistent weekly review of site status, identifying trends of discrepancies and communicating to CRA/CML/clinical leads to address concerning areas/Sites to maintain quality data flow. Analyze the study level data that includes review the system for study level trends (Inforsario Review, SDV backlog reconciliation, review of compliance to tiers). Create i-Site Pack to assist site monitor with onsite visit. Perform Central Investigator file review and follow up to close the observation noted during file review. Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information Perform system updates, CTMS entries for Protocol deviation, Serious Adverse Event between site monitoring visits.Review study data and monitoring plan compliance. Participate in document management (creation, review, maintenance, storage, as applicable) Provide centralized support during monitoring visit and site management for Data driven studies. Conduct routine/triggered Remote monitoring visit. Show less



National Vector Borne Disease Control Programme ( NVBDCP)

• Nagpur Area, India

• Monitor

  • Feb 2013 - Nov 2016

  Monitoring and management of malaria & other vector borne disease control & prevention strategies. Monitoring Antimalarial drug clinical trials, Antimalarial/Insecticide resistance studies. Malaria clinical case studies, overseeing study activities. Provide protocol training to site staff, maintain effective site/project communications. Keep a close association with site (s) for: Patient Recruitment, Patient Follow Up, and protocol related activities. Review Informed consent forms and case report forms, perform drug accountability Performing routine data collection, source data verification, Preparing monitoring and study progress reports, laboratory data reconciliation, SAE reconciliation, collecting data and analysis Assists in preparation of safety, interim and final study reports. Show less