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
2017.08 - 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
2015.06 - 2017.08
- 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
2009.04 - 2017.08
- 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
2009.04 - 2016.05
- 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
2017.08 - Current
Asst. Project Manager Unblinding Processes and Regulatory Affairs
DiagnoSearch Life Sciences Pvt. Ltd.
2015.06 - 2017.08
Executive - Regulatory Affairs
DiagnoSearch Life Sciences Pvt. Ltd.
2009.04 - 2017.08
Sr. Clinical Research Associate
DiagnoSearch Life Sciences Pvt. Ltd.
2009.04 - 2016.05
Master's in Clinical Research -
Cranfield University UK and ICRI
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