PBPearl Braganza
@pearlbraganza
Clinical operations leader with 10 years' experience in global clinical trials and data governance.
IndiaWhat I'm looking for
I am a results-driven clinical operations leader with 10 years of experience managing global clinical trials across oncology, infectious disease, autoimmune, and vaccine studies. I specialize in centralized oversight, data governance, and ensuring compliance with ICH-GCP, SOPs, and local regulations.
I have delivered timely database lock activities, supported FDA audits with no major findings, and implemented CAPA actions to mitigate project risks and preserve data reliability. I collaborate directly with sites, negotiate contracts, manage vendors, and lead cross-functional teams to meet quality and timeline commitments.
I prioritize ALCOA+ compliance, governance, and continuous improvement, and I have experience hosting client audits, managing internal audit schedules, and coordinating training programs to maintain regulatory standards and documentation accuracy.
Experience
Work history, roles, and key accomplishments
IPLed centralized oversight of global oncology, infectious disease, autoimmune, and vaccine trials ensuring ICH-GCP compliance and delivering on-time database locks; supported FDA audits with no major findings and managed vendor/contracts to meet timelines and quality targets.
IPManaged site-level data verification, SAE reporting, and compliance tracking across oncology and cardiology studies; supported database lock activities, audit readiness, and mentored junior CRAs to improve SOP alignment.
IPSupported CTMs with clinical documentation, vendor coordination, system updates, and EC submissions to maintain data integrity and regulatory compliance across global studies.
Junior Research Fellow
National Institute of Immunohematology
Nov 2012 - Aug 2015 (2 years 9 months)
Conducted molecular diagnostics and genetic analyses using PCR and RT-PCR and contributed to peer-reviewed publications and collaborative research projects.
Biology Teacher
Kendriya Vidyalaya No. 2, Navy Nagar
Jan 2012 - Oct 2012 (9 months)
Taught CBSE classes XI–XII Biotechnology and classes VI–X Science, developing curricula and delivering lessons to improve student learning outcomes.
Education
Degrees, certifications, and relevant coursework
SMSt. Xavier's College, Mumbai
Master of Science, Biotechnology
2022 - 2025
Activities and societies: Oncology thesis
M.Sc. Biotechnology pursued at St. Xavier's College with coursework and research in biotechnology completed between May 2022 and Oct 2025.
WMWilson College, Mumbai
Bachelor of Science, Biotechnology
2011 - 2011
B.Sc. Biotechnology program at Wilson College completed in January 2011.
ACACTREC (Advanced Centre for Treatment, Research and Education in Cancer)
Oncology
2010 - 2010
Research project/thesis work conducted at ACTREC focused on oncology as part of academic training in June 2010.
Availability
Location
IndiaAuthorized to work in
Job categories
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