Priya Shirture
Senior Process Associate @Tata Consultancy Services
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WORK HISTORY
Senior Process Associate @Tata Consultancy Services
Thane, IN
Provided Clinical operational support to global study management teams (SMTs) throughout allphases of clinical study management, ensuring adherence to ICH/GCP standards and regulations.• Coordinated activities with Contract Research Organizations (CROs) and vendors, including systemaccess for site personnel, vendor reconciliation, and addressing vendor inquiries, to ensure successfuldelivery against contracted scopes.• Track and maintain study information and report on study progress. Provide guidance to the SMT on theavailability of SMT/Operational/Data Management tracking systems in collaboration with the GlobalStudy Lead (GSL), Global Study Manager (GSM), and Country Clinical Operations Lead (COL).• Collaborated on study initiation, conduct, and closeout activities, ensuring efficient project execution.• Developed, maintained, and managed study documentation and electronic Trial Master Files (eTMF),including uploading, indexing, and performing quality control (QC) TMF reviews, TMF completeness,managing Expected Document List (EDLs) and count, while resolving outstanding issues in VeevaVault by coordination with Country Operational Leads.• Regularly provided study teams with essential data including Study, country, site-level milestoneupdates, Clinical Trial Management System (CTMS) reports, eTMF completeness reports, studypersonnel report and drug shipment documentation.• Managed access control for IXRS and Rave, including granting and revoking user access.• Created and managed various distribution lists to facilitate effective communication among the studyteam members.• Actively participated in study debrief meetings, providing valuable insights and feedback on study-levelprogress.
EDUCATION
Vighnaharta Trust s Shivajirao S Jondhale College of pharmacy
Bachelor of Pharmacy, Pharmacy
Institute of pharmaceutical Education and Research
M pharmacy, Pharmacology and Toxicology
ABOUT PRIYA SHIRTURE
I am a dedicated clinical research professional, experience in clinical operations, study management, and site activation. Currently, I serve as a Clinical Study Associate at TATA Consultancy Services, where I provide operational support to global study management teams (SMTs) and collaborate with Contract Research Organizations (CROs) and vendors to ensure successful delivery of clinical trials in compliance with ICH/GCP standards.With a strong background as a Clinical Research Coordinator at Tata Memorial Hospital, I’ve been directly involved in Pharma-Sponsored Oncology Trials and Investigator Initiated Trials, overseeing participant recruitment, informed consent processes, and regulatory documentation. I’m well-versed in managing TMF, adverse event reporting, site initiation, monitoring visits, and trial amendments.My expertise spans across a variety of clinical trial software systems such as CTMS, eTMF, IXRS, Medidata Rave, and more. I am committed to ensuring the smooth execution of clinical trials from initiation through closeout and possess strong problem-solving skills to resolve monitor findings and ensure adherence to timelines and budgets.I hold a Master’s in Pharmacy and am passionate about advancing clinical research and contributing to the successful implementation of innovative therapies that improve patient outcomes. Always open to new opportunities to collaborate and grow within the field of clinical operations.
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