MADHU GUPTA

1. Study Operations Support

• Contribute to day-to-day execution of clinical studies- startup, conduct & close out studies

• Provide operational input into study deliverables (timelines, plans, trackers,

documents).

• Assist with issue/risk tracking and resolution under GTL guidance.

• Support Global Trial Lead (GTL) in preparing & filling study meetings, IM safety review, CRO Meetings minutes & agenda.

2. Documentation & eTMF Management

•Manage development and/or collection of study-level documents

•Support GTL in ensuring eTMF accuracy, completeness, and inspection readiness.

•Perform quarterly TMF review with cross functional stakeholders.

3. CTMS & System Oversight

• Manage country planning, protocol attributes, and milestone/driver updates in CTMS.

• Ensure timely and accurate data entry to maintain system health.

4. Vendor & CRO Coordination

• Support global team member with vendor-related tasks and quality oversight.

• Track vendor deliverables, non-clinical supply logistics, and key study dependencies.

5. Service Provider & Cross-functional Collaboration

•Collaborate with study teams, country teams, vendors, and internal functions.

•Participate in oversight of outsourced activities, query resolution, financial

reconciliation.

6. Study Planning & Tracking

•Contribute to study timelines, enrolment forecasts, and operational strategy inputs.

•Support updates to trackers, dashboards, study plans, and meeting documentation.

7. Quality & Compliance

•Ensure compliance with ICH/GCP, regulatory guidelines, and internal quality frameworks.

•Maintain documentation and data integrity across systems & repositories.

8. Vendor Management

• Providing internal & external stakeholder access to different portal such as EDC, IRT, Clario, PPD, SharePoint.

9. Additional Responsibilities

•Facilitating onboarding sessions for new hires through a mentor–mente

program.

•Conducting global subject-matter expert (SME)sessions for the covering process

enhancements and orientation for new hires.”

•Delivering a best-practice or knowledge-sharing session by continuous process

improvements.

• CAPA & Deviation Management: Provide deviation and CAPA support by following up with the study team member for relevant information such as IAC (immediate action correction), Root Cause and corrective & preventive action and implementation dates.
• SUSAR Reporting: Maintaining SUSAR distribution lists and quarterly compliance reviews.
• Safety Reporting: Track provision of safety listings from external Sponsor-Investigators, perform reconciliation against Safety Database. Perform Safety reporting within 24/7 for ICSRs (Individual Case Study Report) for regional / local managed company sponsored studies
• Communication: Support Clinical Operation Teams (COT) Meetings Organization, prepare agenda & share meeting minutes.
• Compliance: Ensure data in clinical source systems are up to date, provided necessary dashboards, reports through use of appropriate business software.
• Support study team member during Audit & Inspection.
• Manage study shared mailbox, distribution list & directory update.
• Submit documents for ethics and regulatory approvals.
• Support CRA in preparing essential documents and release of IP.
• Project Management
• Ensures tools are set-up according to SOPs and work instructions (for example, Project Management Plan, SOP list, Team list and Project View).
• Updates and maintains project tracking databases, compiles data for reports, and other project-related materials.
• Assist with the development of sites budgets, contracts, and payments administration.
• Provide Regional Dashboards, prepared systems analytics (e.g. outstanding queries, missing pages, overdue action items etc.)
• Collaborates with PL/PMA on ensuring that study documents are filled as per SOPs.
• Build effective relationships with affiliates, deliver high-quality plans, and address local challenges.
• Certified in Six Sigma-Green Belt, PMP certification

• Document Management: Under supervision, performed administrative tasks to support team members with project execution such as downloading reports, preparing & distributing status reports, creating & maintaining study documents. Provided support in uploading data into systems within the project timeline. Example: vendor management, uploading documents in wingspan and eTMF.
• Study Management: Supported study team members to provide various trackers (SRTe tracker, managing essential study documents) eTMF review etc.
• Vendor Management: Supported multiple stakeholders by providing them external and internal vendor access. Ad-hoc activities such as adding site staff in CTMS, downloading eCRFs.
• Communication: Responsible for follow up with CRAs, CTAs and communication with the project team as per requirements. Responsible for uploading, reviewing, reconciliation and quality check for study documents in eTMF and Share point such as Investigator site file, site visit report, essential documents etc.
• Performed oversight of site visit report (Site initiation, monitoring & close out visit).
• Cleaned studies documents during the close out phase from internal sources.

• Reviewed patients medical history records per company SOPs and guidelines and provided reports to clients per requirement.