Namdeo Gorule

Experience

• 

  Metropolis Healthcare

  May 2011 - Apr 2016

  Associate Team Lead

  1. Managed several study protocols at one time and participated in the management of assigned clinical trials. One point of contact for global as well as regional clients in all matters regarding central lab services. 2. Initiate project set up activities after the clinical study and BA/BE award to us. Manage and handle the completion of clinical laboratory worksheet. 3. Acquire specific clinical and therapeutic knowledge related to studies monitored. 4. Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH guidelines and provide support for pre/post audits, quality assurance activities and final reports. 5. Coordinating with the IT team for the electronic data transfer and Health Level 7 set up, if applicable for the study and training the study team for the same. Conducts user acceptance testing on new system and creates user requirement documentation accordingly. 6. Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information, resolves queries and assists sites in completion of SAE reports. 7. Responsible for accurate and timely data collection, documentation, entry and reporting. 8. Identified quality and performance improvement opportunities and collaborated with staff in the development of action plans to improve quality. 9. Interfacing with the Laboratory sections, Credit Control team, Logistics team, Information Technology team and Business Development team for day-to-day activities. 10. Effectively interacted with team members to drive project goals. 11. Participated in Investigator Meeting and Site Initiation Visit for various studies. Show less

• 

  Tech Observer

  Apr 2016 - May 2018

  Clinical Research Associate

  1. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage on-going project expectations and issues. 2. Conduct initiation visits, monitoring visits and study closure visits with respect to specific monitoring plan to assess compliance to the protocol, regulatory requirements and adequate documentation and prepare visit reports. 3. Verify that the trial related duties are performed only by authorized personnel and that the trial related information is accessed only by authorized personnel. 4. Review on-site files and records, case report forms and source documents for completeness, accuracy, consistency and compliance, identifies deficiencies and discrepancies and provides remedial training and / or initiates corrective action as required. 5. Verify that the investigator provides all the required reports, notifications, applications, and submissions are timely, accurate, legible and complete and dated. 6. Ensure all used/unused trial supplies/storage samples are accounted for and appropriate safety reporting of SAE and AE in accordance to the Sponsor/CRO SOP’s, Protocol, GCP and local regulatory guidelines 7. Verify the recruitment rate and check for any follow up problems based on escalation plan. Motivate investigators in order to achieve recruitment targets. 8. Handled multiple systems related to CTMS, EDC, IXRS, ERT, eTMF, investigator payments and protocol deviations. Perform user acceptance testing for EDC system and provide inputs accordingly during start up Show less

• 

  IQVIA

  May 2018 - Apr 2024

  1. Manage staff in accordance with organization’s policies & applicable regulations. Responsibilities include planning, assigning, & directing work, assessing performance, & guiding professional development, rewarding & disciplining employee & addressing employee relations issues & resolving problems. 2. Participate in the selection process for hiring new employees by conducting candidate review & participating in the interviewing process. Ensure that new employees are properly onboarded & trained. 3. Ensure that staff has the proper materials, systems access, and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review & training experiences. 4. Participate in the allocation of resources to clinical research projects by assigning staff based on their experience, training and study budget. 5. Manage the quality of assigned staff's clinical work through regular review & evaluation of work product. Provide oversight for completion of all project-driven administration, clinical operational activities & financial processes as per clinical trial budgets. 6. Act as a subject matter expert for development of business-related automation system, creating guidance documents for user, overlook execution & provide related training on timely basis. Taking feedback from user on regular interval for new system. 7. Identifies quality risks & issues & create appropriate corrective action plans timely to prevent or correct deficiencies in performance of staff as well as relating to the delivery of projects. 8. Ensures that staff are meeting defined workload, functional deliverables & quality metrics through regular review & reporting of findings as outlined by clinical operations management. Gathering information from cross-functional teams to support project success. 9. Following up & responding to clinical study specific inquiries from sponsor, physicians & CRA by maintaining project related documentation. Show less 1. Participate in the identification of potential investigators, clinical sites, Clinical laboratories and vendor selection as per the specific country regulations. 2. Maintaining study level & site level regulatory & study documents related to study start up activities. 3. Prepare confidentiality and clinical trial agreement with the investigator. Make sure to follow the plan for country and site activation. 4. Prepare Standard Operating Procedures and study specific Working Documents as and when required. 5. Support team as a subject matter expert to prioritized activities and helps to meet project goals by giving strategic inputs. 6. Participate in opportunities for process improvement. Lead or participate in process improvement initiatives, as assigned, and promote the sharing of best practices 7. Responsible for planning, scheduling and implementing the clinical aspects of projects in line with contract and budget, e.g. implementation of protocol and amendments; protocol deviation prevention, tracking and reporting; IP management, timely investigator payments 8. Responsible for driving enrollment as per contracted timelines. 9. Contribute to the development and maintenance of all clinical elements of cross functional project plans. 10. Responsible for coordinating and managing the clinical project team to ensure high performance and productivity of CRAs and optimal utilization. 11. Ensure timely dissemination of information on study progress or issues and/or processes to all team members related to clinical deliverables and accurate tracking of any relevant study information related to clinical deliverables. Show less 1. Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage on-going project expectations and issues. 2. Conduct initiation visits, monitoring visits and study closure visits with respect to specific monitoring plan to assess compliance to the protocol, regulatory requirements and adequate documentation and prepare visit reports. 3. Verify that the trial related duties are performed only by authorized personnel and that the trial related information is accessed only by authorized personnel. 4. Review on-site files and records, case report forms and source documents for completeness, accuracy, consistency and compliance, identifies deficiencies and discrepancies and provides remedial training and / or initiates corrective action as required. 5. Verify that the investigator provides all the required reports, notifications, applications, and submissions are timely, accurate, legible and complete and dated. 6. Ensure all used/unused trial supplies/storage samples are accounted for and appropriate safety reporting of SAE and AE in accordance to the Sponsor/CRO SOP’s, Protocol, GCP and local regulatory guidelines 7. Verify the recruitment rate and check for any follow up problems based on escalation plan. Motivate investigators in order to achieve recruitment targets. 8. Handled multiple systems related to CTMS, EDC, IXRS, ERT, eTMF, investigator payments and protocol deviations. Perform user acceptance testing for EDC system and provide inputs accordingly during start up Show less

  • Associate Manager

    Feb 2022 - Apr 2024

  • Sr. Clinical Research Associate

    Feb 2021 - Jan 2022

  • Clinical Research Associate II

    May 2018 - Jan 2021
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  ICON Strategic Solutions

  Apr 2024 - now

  Manager, Clinical Operations