Sunakshi Paul
Boston,MA
Summary
Experienced and results-oriented Clinical Trial Professional with 8 years of managing global Phase I–III studies across both internal and outsourced models. Skilled in driving cross-functional collaboration, managing CROs and vendors, and ensuring seamless operational execution to meet study milestones. Proven track record in optimizing clinical operations and aligning strategies with development plans. Committed to advancing patient-focused research through operational excellence, regulatory compliance (ICH-GCP), and strong leadership.
Overview
11
11
years of professional experience
Work History
Clinical Trial Manager II
ALEXION PHARMACEUTICALS, INC. ASTRAZENECA'S RARE D
Boston, Massachusetts
08.2022 - Current
- Managing the planning, execution, and delivery of global clinical trials (Phases I–III), ensuring alignment with clinical development plans and timelines
- Developing study-specific plans, Protocol, Informed Consent Forms (ICFs), Vendor Management Plans, TMF Plans, and process flows across multiple clinical vendors
- Managing CROs and clinical vendors, including Central Labs, medication, and equipment providers
- Led vendor and site selection, set up eTMF and other study databases, and coordinated country/site feasibility aligned with corporate strategy
- Collaborating with country operations teams to project enrollment and optimize site performance
- Managing and validated study budgets, ensuring financial considerations supported trial efficiency
- Contributing to planning and execution of study team meetings and Investigator meetings
- Oversaw site enrollment and addressed site-related issues as necessary
- Identifying study risks and coordinated risk mitigation strategies with study teams, CROs, and vendors.
- Tracking compliance with study-level plans and escalated variances or deviations as appropriate
- Reviewing and tracked protocol deviations to ensure compliance with regulatory requirements
- Monitoring vendor-related quality issues and escalated when necessary
- Coordinating study team training in the investigator portal, monitored site/CRA user access, and tracked compliance
- Performing ongoing Trial Master File (TMF) quality control reviews to ensure inspection readiness and regulatory compliance
- Maintaining study task ownership matrices to document and communicate cross-functional and CRO responsibilities
- Tracking and documented training compliance for internal team members and CRO/vendor staff
- Supporting audit and inspection readiness by preparing study documentation, resolving TMF gaps, and ensuring regulatory compliance
- Reviewing CRA monitoring reports and tracked site visit outcomes; collaborated with CRAs and site staff to resolve monitoring findings
- Conducted clinical trial start-up activities, including collection and verification of essential regulatory documents for site initiation and drug release
- Serving as a system expert and point of contact for study-related business technologies
- Led departmental initiatives, implementing process improvements across study teams
Clinical Trial Associate (Oncology), Phase I
Agenus
Boston, Massachusetts
01.2021 - 08.2022
- Managed the oversight of CROs activities and other clinical vendors to ensure the quality met the company's regulatory requirements
- Monitored progress of phase-I oncology clinical trial to ensure they are conducted, recorded, and reported in accordance with
- Monitored the status of clinical data collection of assigned clinical studies from all the sites
- Reviewed clinical monitoring reports and tracking site visit by the CRA's
- Performs clinical trial start-up activities at the site level, including requesting, reviewing, and verifying regulatory documents required for site initiation, and drug release to the sites
Clinical Research Coordinator II (Oncology)
Massachusetts General Hospital
Boston, Massachusetts
01.2018 - 12.2020
- Lead trained and supervised the research team in all aspects of clinical trial implementation for investigator-initiated studies
- Maintained a working knowledge of clinical TMF requirements
- Managed accuracy of investigator agreements, the delegation of authority, training, enrollment, treatment, and monitor visit logs
Vita Data Sciences (a division of Softworld, Inc.)
Clinical Project Coordinator, Co-op
Boston, Massachusetts
07.2017 - 12.2017
- Review data listings and preparation of interim/final clinical study reports
- Maintained proper documentation for all assigned projects
- Prepared internal and external project reports
VASTA GLOBAL
Clinical Trial Assistant (Oncology)
Mumbai, India
01.2015 - 03.2016
- Managed the patient information database for the Memorial Sloan Kettering Cancer Center to track patient records
- Created and maintained database to organize patient information and lab result directed multiple cross-functional trial teams through startup activities including study/site budgets and contracts
Education
Master of Science - Project Management (Clinical Trials Design)
Northeastern University
Boston, MA04-2018
Master of Science - Biotechnology
D.Y PATIL SCHOOL OF BIOTECHNOLOGY ANDBIOINFORMATIC
India 07-2014
Bachelor of Science - Biotechnology
D.Y PATIL SCHOOL OF BIOTECHNOLOGY ANDBIOINFORMATIC
India 07-2013
Skills
- Effective cross-team collaboration and highly adaptive to new technology and systems (AI)
- Agility: Able to quickly adapt to study changes Communicates and implements changes in a positive manner
- Experience working on global Phase I, II and Phase III studies
- Knowledge ICG/GCP
- Proficient with CTMS, eTMF, Veeva Vault, Microsoft Teams, SharePoint, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Timeline
Clinical Trial Manager II
ALEXION PHARMACEUTICALS, INC. ASTRAZENECA'S RARE D
08.2022 - Current
Clinical Trial Associate (Oncology), Phase I
Agenus
01.2021 - 08.2022
Clinical Research Coordinator II (Oncology)
Massachusetts General Hospital
01.2018 - 12.2020
Vita Data Sciences (a division of Softworld, Inc.)
Clinical Project Coordinator, Co-op
07.2017 - 12.2017
VASTA GLOBAL
Clinical Trial Assistant (Oncology)
01.2015 - 03.2016
Master of Science - Project Management (Clinical Trials Design)
Northeastern University
Master of Science - Biotechnology
D.Y PATIL SCHOOL OF BIOTECHNOLOGY ANDBIOINFORMATIC
Bachelor of Science - Biotechnology
D.Y PATIL SCHOOL OF BIOTECHNOLOGY ANDBIOINFORMATIC
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