Suprith Jawali

Experience

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  MANKIND PHARMA LTD

  Sept 2015 - Mar 2016

  Senior Field Marketing Manager
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  Navitas Life Sciences

  Aug 2018 - Jun 2021

  Research Associate

  • Facilitated registration of volunteers and provided counseling throughout the screening process, ensuring smooth coordination of screening-related activities.• Organized study-specific informed consent processes and meticulously reviewed Informed Consent Forms.• Prepared essential documents and actively contributed to study initiation activities.• Executed the clinical phase of studies and generated comprehensive reports, while reviewing critical documents such as protocols and clinical study reports.• Monitored pharmacy activities, including the identification, dispensing, and archival of (IP) investigational products, while ensuring meticulous documentation review.• Expertly managed clinical data and focus thorough reviews of eCTD reports.• Ensured end-to-end verification of study documents, ensuring compliance with SOPs, GDP, and regulatory requirements.• Actively participated in regulatory audits, including DCGI, US-FDA, Austrian, Malaysian, and Sponsor Audits. Show less

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  IQVIA India

  Jul 2021 - now

  Associate Centralized Monitor

  Currently, I am handling 07 studies with different Therapeutic areas like Cardiovascular disease, Neuroscience, Inflammation and Hematology/Oncology.• Possess excellent Project Management, Coordination, Organization and Research oriented skills• Certified with ICH-GCP guidelines.• Developed excellent working knowledge of industry trends and improvements in processes.• Enhanced working relationships by participating in team-building activities.• Met client delivery using excellent planning and coordination skills.• My key responsibilities as a Associate CM includes conducting periodic review of site level Key Risk Indicators (KRIs) and historic site performance according to Central Monitoring Plan (CMP) and GDE Guidance• Early identification of site-level risk/issue(s) occurring during study conduct and responsible for providing action to Clinical Monitors (or CRAs)• Monitor site performance and make recommendations for timely corrective actions (e.g Site Telephone Contact / email or Triggered Onsite/ Remote Monitoring Visit).• Conduct periodic review of site level KRIs and historic site performance according to the Central Monitoring Plan.• Manage and monitor operational insight of the assigned project(s) and complete/oversee the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, and action clinical study alerts, monitor clinical operation plan (COP), compliance etc.).• Track and assess trending of violations/deviations, enrollment status, and outstanding issues.• Supporting study start-up by attending kick off meetings and in designing the Central Monitoring Plan as per the study requirement.• Mentoring and training Central Monitors on studies, process as well as Sponsor SOPs. Show less