Summary
Overview
Work History
Education
Skills
Therapeutic area experience
Certification
Certification
Websites
Timeline
Generic
Deepak Yadav

Deepak Yadav

Gurugram

Summary

Centralized Monitoring Lead at IQVIA specializing in risk mitigation and data integrity. Demonstrated success in process improvement and collaboration, leading to superior project outcomes. Expertise in data trend analysis and effective communication enhances stakeholder satisfaction and streamlines project timelines.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Centralized Monitoring Lead

IQVIA
04.2022 - Current
  • Providing leadership of the Centralized monitoring team, in partnership with project team, and in collaboration with other functional teams, to achieve the delivery of the Project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with organization standard operating Procedures.
  • The Role has particular focus on leading/advising the centralized team towards solutions to clinical risks and critical data points identified and facilitating successful implementation of those strategies to address and mitigate the identified risks using different tools and methodologies.
  • Early identification of site-level risk/issues(s) occurring during study conduct and responsible for mitigation of risk. Monitor site performance and make a recommendation for timely corrective actions (e.g site contact or Triggered Onsite Monitoring Visit)
  • Oversee and perform trigger management compliance. Provide technical support in conducting in-stream data trend analysis in support of data quality and integrity (Included protocol compliance and targeted review of patient data). Conduct periodic review of site level key risk indicators and historic site performance according to central monitoring plan.
  • Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed. Preparation and review of the risk assessment and mitigation plan. Monitor operational triggers/Key data points/data trends and monitor their compliance check by performing regular quality check.
  • Provide technical inputs in developing study specific documents, plans, applications. Provide centralized monitoring support to the relevant stake holders within the project team in developing the study management plan, tools and templates and maintain the team accountabilities as applicable. Provide resolution to the internal study team on study specific issues highlighted in the study.
  • Project oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, standard operating procedures, respective regulation, and guidelines. Collaborating with peers and promoting cross functional synergies.
  • Ensure Subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance standard operating procedure and ICH GCP guidelines, protocol requirements and regulatory compliance.

Quality Assurance Auditor

Veeda Clinical research
01.2021 - 04.2022
  • Essential documents and study plan review: Conduct quality checks to ensure the accuracy of data included in documents in compliance to the SOPs and regulatory guidance and requirements.
  • Audit Planning, conduct, report preparation, compliance verification, corrective and preventative actions (CAPA) closure and management of Study based audits for clinical trials.
  • Clinical trial sites/ investigator site audit and releasing audit certificate, System Audits, Vendor/supplier audits.
  • Lad inspection readiness and inspection preparation activities, including SME training/preparation as needed. Support the department on regulatory or client audits in collaboration with QA department.
  • Partner with data operation and QA teams to drive quality and compliance. Develop and maintain the training Plan, training materials, conduct and coordinate system and process trainings.
  • Review, write or revise SOPs as and when required. Review CAPA, Change Control, Deviation Management, and process improvement.

Clinical Research Associate

Panexcell clinical lab Pvt. Ltd.
10.2018 - 12.2018
  • Perform site identification and conduct feasibility studies, perform site selection, site initiation, site monitoring and site close out and prepare reports and follow-up letters for the same, I keep data accurate and continuously improve my disciplined reporting capabilities to meet the timelines of the study.
  • Accountable to keep a close association with site(s) for patient recruitment, IMP administration, patient follow up, SAE reporting and handling if any, protocol deviation and other site related issues. Maintain accurate and timely site correspondence and communication.
  • Training of Investigators on Protocol and other applicable regulatory guidelines including local regulatory guidelines, Review study related documents such as ICF, source documents, eCRF, patient diary etc. to ensure proactive problem management and to keep site ready for Regulatory/Sponsor audit.
  • Training of site staff on filling of logs and forms, ICF process, SAE reporting timeline, follow-up instruction of patients and documentation of protocol deviation if, any.
  • To evaluate the speed of recruitment and proposed alternative solutions, if the objectives are not met either in terms of patient number or timelines.
  • Number of Site visits performed as a Monitor
  • Site Selection visit: 11
  • Site Initiation visit: 8
  • Site Monitoring visit: 42
  • Site Close-out visit: 10

Clinical Research Coordinator

PGIMER, Chandigarh
Chandigarh
02.2018 - 10.2018
  • Assisted the investigator in conducting the study as per the GCP guidelines and standard operating procedures of the site also assisted the investigator in the Screening process, informed consent process, coordinated and managed laboratory samples and ensured follow up of lab report.
  • Ensured proper investigational product management, dispensing, accountability and temperature monitoring Verified the accuracy and validity of data entered in database Completed eCRF entry and source documents with minimal error. Prepared, attended and followed-up monitoring visit and resolved queries within a stipulated time.
  • Assisted investigator in all ethics committee correspondence and communication and was also responsible for the Submission and notification of all regulatory and project related documents to EC. Ensured compliance of regulatory standards and SOPs both internal and external.
  • Used interactive web response services for patient’s accurate randomization and ensured proper collection and shipment of specimen at the site.

Education

Post Graduate Diploma - Clinical Research

Anovus Institute of clinical research
Chandigarh, INDIA
02.2018

Bachelor’s degree - pharmacy

pt.bd. Sharma University of health sciences
Rohtak, INDIA
07.2017

Skills

  • Process improvement through active listening
  • risk management
  • Time management and task prioritization
  • Concise communication with peers and management
  • Collaborative teamwork and discussions
  • Problem-solving skills through knowledge application

Therapeutic area experience

  • 1. Oncology
  • 2. Rheumatology
  • 3. Dermatology
  • 4. Hematology
  • 5. Ophthalmology

Certification

  • Have been part of a team who successfully completed EMA regulatory Inspection of one oncology trial.
  • Apart from participation, received best learner certificate in clinical operation workshop on “Best Practices in Monitoring” held in Mumbai.
  • Received appreciation from company’s Vice president for achieving the DBL 2 days prior to the scheduled timeline in one of the studies.
  • Awarded spotlight award in March 2024 for my significant contribution in the project. Was recommended by my Line Manager.
  • Have completed below courses on LinkedIn along with certificates.
  • 1. Critical Thinking for Better Judgment and Decision Making
  • 2. Demonstrating Accountability as a Leader
  • 3. Time Management Fundamentals

Certification

Attended Conference on Dissemination of ICMR (Indian Council of Medical Research) National Ethical Guidelines 2017, held in PGIMER (Post graduate institute of medical education and research) Chandigarh| INDIA.

Timeline

Centralized Monitoring Lead

IQVIA
04.2022 - Current

Quality Assurance Auditor

Veeda Clinical research
01.2021 - 04.2022

Clinical Research Associate

Panexcell clinical lab Pvt. Ltd.
10.2018 - 12.2018

Clinical Research Coordinator

PGIMER, Chandigarh
02.2018 - 10.2018

Post Graduate Diploma - Clinical Research

Anovus Institute of clinical research

Bachelor’s degree - pharmacy

pt.bd. Sharma University of health sciences

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Deepak Yadav