Summary
Overview
Work History
Education
Skills
Vendor Experience
System Experience
Geographic Experience
References
Languages
Websites
Timeline
Generic

Priyanka Singh

Mumbai

Summary

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
  • Mexico, Endocrinology, Regulatory Affairs Associate
  • New Zealand, Immunology, Oncology, Start-Up Lead
  • Philippines, Start-Up Lead, Regulatory Affairs Associate
  • Poland, Endocrinology, Start-Up Lead
  • Singapore, Oncology, Immunology, Start-Up Lead
  • South Korea, Infectious Diseases, Dentistry, Oncology, Endocrinology, Neurology, Immunology, Start-Up Lead, Regulatory Affairs Associate
  • Taiwan, Infectious Diseases, Oncology, Immunology, Neurology, Start-Up Lead
  • Thailand, Hematology, Endocrinology, Immunology, Dentistry, Start-Up Lead, Regulatory Affairs Associate
  • United Kingdom, Oncology, Infectious Diseases, Start-Up Lead

References

Available upon request.

Languages

Hindi
First Language
English
Advanced (C1)
C1
Marathi
Beginner
A1

Timeline

Site Activation Lead

ICON, formerly PRA Health Sciences
08.2017 - Current

Asst. Project Manager Unblinding Processes and Regulatory Affairs

DiagnoSearch Life Sciences Pvt. Ltd.
06.2015 - 08.2017

Executive - Regulatory Affairs

DiagnoSearch Life Sciences Pvt. Ltd.
04.2009 - 08.2017

Sr. Clinical Research Associate

DiagnoSearch Life Sciences Pvt. Ltd.
04.2009 - 05.2016

Master's in Clinical Research -

Cranfield University UK and ICRI
Priyanka Singh