SPShreya Pakalpati
@shreyapakalpati
Experienced Clinical Trial Manager with a focus on operational excellence.
United StatesWhat I'm looking for
I am a dedicated Clinical Trial Manager with extensive experience in overseeing global clinical trials, particularly in oncology. Currently, I manage operational aspects of P2 and P3 lung cancer trials at Arcus Biosciences, where I ensure that trial deliverables are met while maintaining strong relationships with cross-functional partners. My role involves developing clinical study plans and providing operational input for submissions to global health authorities, demonstrating my commitment to operational excellence and compliance.
Previously, I served as a Clinical Trials Management Associate at Gilead Sciences, where I led global oncology and hematology trials. My responsibilities included vendor management, budget oversight, and authoring operational documents. I pride myself on being a highly motivated self-starter who drives process efficiencies and maintains a patient-focused approach. My background in research, combined with my strong organizational skills, allows me to contribute effectively to clinical operations and ensure study success.
Experience
Work history, roles, and key accomplishments
Clinical Trial Manager
Arcus Biosciences
Sep 2023 - Present (1 year 9 months)
Overseeing global operational aspects of P2/NSCLC trials, managing sites, CROs, and vendors. Collaborating with partners to achieve study objectives and developing clinical study plans. Providing operational input for global health authority submissions and facilitating strategic planning meetings.
Clinical Trials Management Associate
Gilead Sciences
Mar 2022 - Jun 2024 (2 years 3 months)
Led global Oncology and Hematology trials, managing vendors and authoring operational documents. Oversaw budget responsibilities and facilitated feasibility efforts for trial sites. Developed strong site relationships and ensured compliance with health authority submissions.
Clinical Project Associate
Gilead Sciences
Apr 2021 - Mar 2022 (11 months)
Managed databases and study plans to ensure compliance and inspection readiness. Conducted routine reviews of monitoring reports and invoices for P1 trials, demonstrating proficiency in MS Office and strong organizational skills.
Research Assistant
University of Washington Medical Center
Aug 2020 - Apr 2021 (8 months)
Served as the primary contact for study participants, ensuring compliance with study protocols. Managed data across multiple databases and prepared reports for study progress, adhering to IRB and sponsor requirements.
Research Assistant
Cognitive and Cortical Dynamics Lab
Sep 2018 - Jun 2020 (1 year 9 months)
Coordinated participant recruitment and adherence to lab protocols. Supported data analysis and report writing, and trained new research assistants on best practices and lab equipment.
Education
Degrees, certifications, and relevant coursework
UWUniversity of Washington
Bachelor of Science in Psychology and Bachelor of Arts in English, Psychology, English
Activities and societies: Founder/President, Peer to Peer Psychology Assoc.; VP+Treasurer, Synapse@UW; Advisor to Dean Stacey, ASACS; TA PSYCH 357 (Dr. Kenny); Senator, ASUW; RA, UW Resilience Lab; RA, Harris Lab; K-5 Tutor, Pipeline Project.
Completed a Bachelor of Science in Psychology and a Bachelor of Arts in English with honors. Engaged in various extracurricular activities including founding and presiding over the Peer to Peer Psychology Association, serving as VP and Treasurer for Synapse@UW, and advising Dean Stacey at ASACS. Additionally, worked as a Teaching Assistant for PSYCH 357 and participated in multiple research assist
Availability
Location
United StatesAuthorized to work in
Job categories
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