Shivam Jani

Experience

• 

  Cliantha Research Limited

  Mar 2014 - Jun 2014

  Research Scientist
• 

  SUN PHARMA

  Jul 2014 - Mar 2018

  Streamlined Clinical Trial Operations (3+ Years)Summary:I thrived in both Clinical Research Associate (CRA) and Clinical Research Monitor (CRM) roles, contributing to the successful execution of clinical trials across various therapeutic areas. My expertise lies in site management, protocol adherence, data accuracy, and regulatory compliance.Accountabilities:• Managed assigned clinical trials from start-up to close-out, ensuring adherence to protocols, ICH- GCP guidelines, and regulatory requirements. • Patient recruitment, informed consent process, and enrollment.• Conducted site feasibility assessments, monitoring visits, patient recruitment activities, and source data verification (SDV).• Performed accurate and timely data collection, source data verification, and accurate data entry. • Built strong relationships with investigators and site staff to facilitate effective communication and data collection.• Maintained comprehensive and accurate clinical trial documentation – trial master file (TMF), EC submission package.Key Achievements:• Minimized protocol deviations through effective site training and monitoring. • Streamlined data collection and management processes, improving data quality. Show less Key Responsibilities:• Managed assigned clinical trials from start-up to close-out, ensuring adherence to protocols, ICH-GCP guidelines, and regulatory requirements. • Patient recruitment, informed consent process, and enrollment.• Conducted site feasibility assessments, monitoring visits, patient recruitment activities, and source data verification (SDV).• Performed accurate and timely data collection, source data verification, and accurate data entry. • Built strong relationships with investigators and site staff to facilitate effective communication and data collection.• Maintained comprehensive and accurate clinical trial documentation – trial master file (TMF), EC submission package. Show less

  • Clinical Quality Monitor - CRA

    Jul 2017 - Mar 2018

  • CRA

    Jul 2014 - Jun 2017
• 

  MACLEODS PHARMACEUTICALS LTD.

  Mar 2018 - Aug 2018

  Clinical Qulity Auditor
• 

  Alembic Pharmaceuticals Limited

  Aug 2018 - Nov 2022

  Quality Assurance
• 

  Labcorp Drug Development

  Nov 2022 - Jun 2023

  System Technology Compliance Specialist
• 

  Fortrea

  Jul 2023 - Nov 2024

  System Technology Compliance Specialist

  Enhancing Compliance and Data Integrity: Developing Robust processes for Computerized Systems, emerging technologies and ITAccountabilities:• Leading and executing all phases of the SDLC from requirements gathering to URS development, test planning and execution, and final report generation.• Assisting the risk assessments to identify potential improvement opportunity and implementation appropriate controls.• Review of functional and system testing to ensure system functionality aligns with intended use.• Effectively contribute to the comprehensive validation documentation, including user requirements specifications, risk assessment, test plans, and reports.• Collaborating effectively with cross-functional teams, including IT, Functional, QA, and regulatory affairs to ensure effective implementation of SDLC best practices.• Proactively identifying and mitigating potential compliance risks associated with computerized systems used in regulated environments.• Maintaining a deep understanding of evolving regulatory requirements and translating them into actionable plans and documentation. • Stay current with evolving regulations and industry standards through continuous learning and training.Experiences:• Strong understanding of system development lifecycle-SDLC (V-model, Agile, Waterfall)• Excellent analytical and problem-solving skills.• Strong attention to detail and ability to work independently and as part of a team.• Considerable knowledge of regulations including, ICH GCP, EMA, ANVISA, 21 CFR 11, GAMP, GDPR, ISO 27001, EU Annex 11, ISO9001• Analytical and problem-solving • Proficiency in relevant CSV tools and technologies Show less

• 

  Clarivate

  Nov 2024 - now

  Compliance Manager