Dynamic and results-driven Site Activation Lead with over a decade's experience in clinical operations, encompassing roles such as Sr. CRA, Regulatory Lead (APAC), and Unblinded Project Management. Seeking opportunities to leverage expertise in study start-up, regulatory affairs, and project management at [Target Company], contributing to successful clinical trial delivery.
Overview
15
15
years of professional experience
Work History
Site Activation Lead
ICON, formerly PRA Health Sciences
Mumbai
08.2017 - Current
Successfully led the start-up activities of 7 studies in the APAC region, specializing in Oncology, Autoimmune Disorders, and Therapeutic Areas
Created daily reports detailing progress of tasks and activities at the site.
Organized training sessions for new hires to familiarize them with company policies.
Coordinated with Global Regulatory Affairs Lead (GRAL) and Clinical Team Manager (CTM) to ensure timely activations and adherence to regulatory timelines
Mentored, coached, and trained IHCRAs, SULs, and other team members, fostering a collaborative and high-performance culture
Facilitated instructor-led courses on Clinical Operations, contributing to the development of the team's skillset
Implemented and enhanced clinical systems to improve project start-up delivery.
Asst. Project Manager Unblinding Processes and Regulatory Affairs
DiagnoSearch Life Sciences Pvt. Ltd.
Thane
06.2015 - 08.2017
Planned and oversaw unblinded drug monitoring activities in India and Australia, managing a team of CRAs
Developed supply plans and tracking tools for investigational product management, ensuring no instances of non-availability at sites
Played a crucial role in project meetings, resolving issues, providing resolutions, and conducting necessary training.
Executive - Regulatory Affairs
DiagnoSearch Life Sciences Pvt. Ltd.
Thane
04.2009 - 08.2017
Led regulatory-related activities for global projects in multiple countries, ensuring compliance with local regulations
Successfully obtained timely approvals in countries with slow review processes
Managed clinical trial application dossiers, followed up for approvals, and maintained communication with regulators.
Sr. Clinical Research Associate
DiagnoSearch Life Sciences Pvt. Ltd.
Thane
04.2009 - 05.2016
Conducted feasibility assessments, site evaluation visits, and monitoring visits, contributing to successful database lock
Coordinated with sites, sponsors, and vendors for study conduct in compliance with GCP, SOP, and regulatory guidelines
Actively participated in organizing Investigator Meetings and contributed to the tracking of study-related activities.
Education
Master's in Clinical Research -
Cranfield University UK and ICRI
05.2007
Skills
Study Start-Up Management
Regulatory Affairs
Project Management
Feasibility Assessments
Clinical Operations
Team Leadership
Risk Identification and Mitigation
Excellent Interpersonal Communication
Mentoring and Coaching
Vendor Experience
Drug Packaging & Distribution, Bilcare, Fisher Clinical Services, World Courier
EDC / eDiary / e-PRO, Signant
Import Licenses, Fermish
Other, Ancillare
ECG, Clario
System Experience
Clinical Trial Management Systems, Siebel Clinical (CTMS), Predictive System Operations
EDC, Oracle Inform, Medidata Rave
IVRS/IWRS/RTSM, Phase Forward
TMF, Veeva Vault ETMF, PhlexEview eTMF
Geographic Experience
Australia, Endocrinology, Start-Up Lead, Clinical Team Manager
Hong Kong, Immunology, Infectious Diseases, Oncology, Hematology, Start-Up Lead
India, Infectious Diseases, Endocrinology, Immunology, Dentistry, Hereditary Disorders, Cardio-Metabolic Diseases, Oncology, Neurology, Regulatory Affairs Associate, Clinical Research Associate, Start-Up Lead, Clinical Team Manager
Malaysia, Oncology, Immunology, Dentistry, Endocrinology, Start-Up Lead, Regulatory Affairs Associate