Mahathi Durbha

• Currently working on Oncology (Phase III) and HIV & Infectious diseases (Phase I) studies.
• Responsible for managing study execution of trial from start-up through close-out, with the focus on achieving timelines and tracking down of microtimelines /databases/tracking tools to the study team in study coordination activities.
• Study start-up activities: Providing contribution for development/review of study documents, eTMF EDL review, Coordinating with different stakeholders, Vendor contracts and negotiations, Country and Site activation activities, Budget review and reconciliations.
• Study Conduct activities: Collaborating with cross functional study team members, leading Clinical operations meeting, Responsible for Trial management activities like Study/Country/Site management, Protocol deviation review, Risk Management(identification and mitigation plans), Budget review.
• Preparation and update of study Documents and study plans.
• Representing as first Point of contact for the Country Leads from the central team, supporting in Recruitment strategies, tracking the issue resolutions.
• Coordinating eTMF completeness check/Spot check at all defined milestones.
• Liaising with Data management/Stats/Central Monitoring teams for Data cleaning activities during interim and final analysis (DBL).
• Identifying issues, conduct root cause analysis, work on CAPAs, Escalating the issues to higher management as and when needed.
• Create and maintain the study trackers as needed.
• Oversight for Vendors in monitoring upon agreed activities and acting as first point of contact for updates and issue resolutions.
• Study Closeout and study archival activities: Study metrics analysis and review, Final check for pending document review as per EDL in eTMF, supporting the Country Leads and CRAs for closing the sites in CTMS.
• Supporting Study Delivery Lead and study team for CSR report preparation and study archival as per defined timelines.
• Working in close partnership with Study Delivery Leads, Country leads, CRAs, Medical monitor, Data Managers, Statistics, and lab managers, Study Manager plays a pivotal role in successful trial conduct and in Study delivery results, providing subject matter expertise across key processes and systems through the life cycle of study.

• Completion and maintenance of internal systems/databases/tracking tools and project plans (CSAP) and supporting the study team in study coordination activities and administrative activities
• Development/review of study documents, vendor management, cooperation with Local Operating Companies (LOCs) and other internal functions, if required
• Ensuring inspection readiness state by taking an oversight over study eTMF completeness
• Involved in Vendor management & CRO oversight – agreeing on study specific setup requirements, ensuring continued monitoring of agreed delegated activities
• Executes trial management activities, as delegated by Study Delivery Lead (SDL) for in-house and outsourced studies across all phases and therapy areas, in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice
• Setting up and maintaining systems and tracking tools that ensure quality, consistency, and integration of study data, following up on discrepancies if needed
• Granting access to new system users
• Supporting SDL to ensure inspection/audit readiness, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination)
• Support in managing the study team's communication: meetings preparation, scheduling, meeting minutes), Newsletters, action logs, communication plans, team lists etc.

Involved in clinical supplies and recruitment materials management –having oversight on study level supplies availability, coordinating and communicating issues to continuity of supplies, proposing solutions as appropriate

• ETRTR (Event Triggered Real-Time Review)- Remote Monitoring of study-specific critical events in targeted subject visits to ensure overall compliance as per ICH-GCP and the study protocol.
• Evaluate PI oversight, subject safety and study processes in order to assess the site's ability to conduct the study.
• Ad-hoc clinical listings review, tracking trends, violations and deviations, site status, enrollment, CRF status and SAE follow-up.
• Review of Key Risk Indicators based on Risk based Monitoring model.
• Query Management in EDC system.
• Deviation Reconciliation Subject Visit Tracking in CTMS.
• Electronic file reviews, reconciliation of subject data between different systems like IRT, EDC, CTMS.
• CTMS Support Tasks- Well-versed with CTMS, TMF system(Veeva Vault), Power BI.

· Support PM/CTM in creation of study documents, checklists, reports as needed.

· Creating minutes of Meeting and distributing to the team post calls.

· Perform File reviews and update outstanding issues in the project tracking tools.

· Maintaining TMF for its up-to-date readiness to audits.