Anusuya Goswami

I am handling multiple high-visibility projects and closely working with CRAs and clinical team leads to identify inconsistencies, trends, protocol deviations, missing data, and safety concerns.

I have worked in various phases of studies during my tenure, from start-up, maintenance, and close-out.

Key responsibilities:

• User Acceptance Testing (UAT): Write and execute UAT scripts for study-specific and new platforms.
• Risk Reviews & Mitigation: Conduct ongoing reviews, recommend mitigation actions, and ensure issue resolution.
• Monitoring Adjustments: Suggest changes to monitoring intervention levels.
• Risk Assessment Meetings: Organize and lead study risk assessment meetings.
• Risk Reports Management: Upload monthly risk review reports to e-TMF, Veeva Vault, or central repositories.
• Quality and Study Risk Reports: Prepare and distribute reports during study conduct and close-out.
• Study Risk Assessment Support: Assist leads in detailed study risk assessment activities.
• Data Visualization & Informatics: Support platform development and design visualizations integrating study data (EDC, laboratory, etc.).
• Plan Development & Updates: Draft and update the Configuration Plan, Central Monitoring Plan, and other applicable plans based on evolving study risks.

• Responsible for completing the Event-Triggered Real-Time Review (ETRTR) for subject data across various systems. Duties include raising manual queries in EDC, creating findings, and protocol deviations wherever applicable. Additionally, customizing ETRTR checklists and collaborating with CRAs to maintain data accuracy. Ensure audit readiness by developing and maintaining study management plans and documentation.

• Support project managers (PMs) and clinical team managers (CTMs) in creating study-specific documents, plans, trackers, checklists, and reports. Track documents and subject visits in CTMS, manage study team access to various portals (CTMS, EDC, Veeva, etc.), and coordinate eTMF/Project file setup. Perform file reviews, log outstanding issues, and submit documents to internal and central files. Draft and distribute meeting minutes, maintain task lists, and track study progress. Additionally, I was the SME of the team and have trained the new joiners for role-specific activities. I have also been an active participant in different events conducted across the company.