Mayuri Rao

• Lead and oversee the study start-up activities for multiple clinical trials, ensuring timely and efficient site activation in line with project timelines.
• Act as the primary liaison between the study team, clinical sites, and external stakeholders to ensure the smooth execution of site start-up tasks.
• Monitor and track the progress of site activation, identifying potential risks or delays, and taking proactive actions to ensure all sites are activated on schedule.
• Oversee the preparation, review, and distribution of essential study documents (e.g., informed consent forms, investigator brochures, clinical trial agreements).
• Ensure timely and accurate submission of regulatory documents (IRB/IEC submission), and assist sites in preparing documents for approval.
• Lead, train, and mentor the Study Start-Up team, ensuring adherence to internal Standard Operating Procedures (SOPs), and promoting continuous professional development.
• Identify, escalate, and resolve site-related issues or delays by coordinating with cross-functional teams, including clinical operations, data management, and project management.
• Develop and maintain study-specific start-up timelines, track milestones, and ensure that all activities are completed as per regulatory and project requirements.
• Provide regular status updates on site start-up activities in internal and external project meetings, ensuring alignment with overall project goals.
• Proactively suggest process improvements to enhance the efficiency and quality of the study start-up phase, contributing to a more streamlined workflow.

Key Accomplishments:

• Led 60+ clinical trial sites to 100% on-time site activation, exceeding project timelines, and improving overall study efficiency.
• Improved the productivity of the Study Start-Up team by providing targeted training and mentorship, resulting in a 25% decrease in onboarding time for new team members.
• Introduced new tools and strategies to track study start-up progress, increasing efficiency by 20%, and reducing administrative overhead.

• Supported the preparation and submission of essential regulatory documents to ensure timely site initiation and activation, in compliance with study timelines.
• Performed collection, review, and organization of essential documents, ensuring they are accurate, complete, and ready for regulatory submission.
• Worked closely with clinical operations, regulatory affairs, and other teams to ensure smooth coordination during the start-up phase.
• Monitored and tracked the progress of site activation, ensuring that all documentation is submitted on time, and all issues are resolved.
• Offered training and mentorship to incoming Study Start-Up Associates, helping them understand processes related to site activation, regulatory submissions, and document management.
• Regularly reviewed the work of other associates, providing constructive feedback and coaching to ensure quality standards and compliance with study timelines.
• Encouraged a collaborative atmosphere within the team, promoting open communication and teamwork to ensure successful study start-up execution.

Key Accomplishments:

• Played a lead role in streamlining study start-up processes, workflows and overall set-up of the study start-up department.
• Mentored 9 internal study start-up team members on US site activation processes, regulatory submissions, and document management within Veeva.
• Contributed to the successful completion of an audit by ensuring that all site regulatory documents were properly organized, complete, and in compliance with ICH-GCP and FDA regulations, resulting in zero findings during the audit.

• Coordinate and execute all start-up activities for assigned clinical trials, ensuring timely site initiation, and regulatory compliance.
• Serve as the main liaison between the study team and investigative sites for all site-related start-up queries and activities.
• Prepare and distribute essential study documents (e.g., informed consent forms, investigator brochures) and ensure proper documentation is collected and uploaded to the Clinical Veeva Vault.
• Monitor and track site start-up progress, ensuring that all sites are activated on schedule as per the study's timelines.
• Collaborate with clinical operations, project management, and regulatory teams to resolve any issues or delays during the study start-up phase.
• Train and mentor junior team members on start-up procedures and best practices to ensure consistency and adherence to internal SOPs.
• Identify any start-up challenges or delays, and assign them to appropriate team members for timely resolution.
• Attend internal and external project meetings, providing updates on the status of study start-up activities, and ensuring action items are completed on time.

Key Accomplishments:

• Recognized as the Subject Matter Expert (SME) and primary point of contact for all Study Start-Up and TMF-related queries across cross-functional teams.
• Successfully managed competing priorities across high-priority studies, resulting in timely delivery, and effective communication with stakeholders resulted in customer satisfaction and project management recognition.
• Strengthened communication with selected sites by providing clear and timely updates on regulatory requirements, resulting in a 30% improvement in document turnaround time, and faster site initiation.

• Led the TMF setup, TMF management, TMF QC, and TMF close-out activities across multiple studies.
• Ensured overall TMF quality and completeness by maintaining appropriate document filing, coordinating cross-functional document management (including third-party documents), and providing regular TMF tracking and reporting to both internal and external stakeholders.
• Ensured the TMF Plan aligns with ICH-GCP guidelines, Good Documentation Practices, and the TMF Reference Model.
• Verified that all new and updated records are accurately entered into the eTMF Veeva Vault to maintain inspection readiness.
• Led the tracking and management of essential documents across assigned studies and sites, ensuring timely receipt and compliance.
• Worked closely with Clinical Research Associates (CRAs) and the Clinical Study Managers (CSMs) to provide updates and support on site initiation and activation activities.
• Developed and maintained essential project documents, such as Site Activation Checklists, Site Essential Document Trackers, Trial Master File Plans, TMF Guides, and Work Instructions for assigned projects.
• Conducted onboarding and mentoring of new TMF team members, ensuring effective integration into TMF processes and company procedures.
• Demonstrated sound judgment in prioritizing and managing multiple competing tasks in a fast-paced environment, ensuring deadlines are consistently met.

• Conducted thorough quality control (QC) and detailed reviews of clinical trial documents (e.g., informed consent forms, FDA forms, CVs, financial disclosure forms) to ensure compliance with regulatory requirements (e.g., FDA, EMEA, ICH-GCP, SOPs, and working practice guidelines).
• Managed the setup, maintenance, and reconciliation of trial master files (TMFs) in Veeva eTMF, ensuring all documents were accurately filed and up to date.
• Maintained tracking tools to monitor the status of clinical trial documents, ensuring timely and accurate documentation management.
• Assisted in the preparation and management of study documents, including model informed consent forms, study manuals, and other clinical trial-related materials.
• Coordinated and maintained the generation of clinical trial status reports, ensuring that all stakeholders were updated on progress and document statuses.
• Generated and reviewed reports from internal tracking systems at requested intervals to ensure comprehensive tracking and management of TMF documents.
• Worked with Quality Assurance (QA) to implement Standard Operating Procedures (SOPs) related to TMF management, records retention, and the shared drive posting of clinical trial documents.
• Actively participated in cross-functional internal study team meetings, contributing to discussions, and documenting meeting minutes.

• Conducted validation and implementation of eCRF reports within Axiom Fusion Reporting Tool as part of study's data management needs.
• Generated comprehensive management and clinical data reports.
• Updated data management documents such as DataManagement Plans, Data Integrity Plans, and Data Export Specifications per client request.
• Supported creation and execution of site training materials.
• Conducted thorough reviews of assigned study data.
• Monitored eCRF data entry and ensured query resolution with sites.
• Responsible for validating data exports and data sets prior to release to the client
• Supported maintenance of the Axiom Fusion eClinical Suite study database with guidance from Lead Data Manager and Project Manager.
• Ensured seamless project execution through effective collaboration.

• Oversee the engagement and recruitment process for clinical trial sites, ensuring timely and efficient enrollment in alignment with study objectives.
• Served as the primary point of contact for sites, ensuring clear communication regarding trial requirements, timelines, and recruitment strategies.
• Tracked site recruitment status and collaborate with clinical teams to address any issues or delays, ensuring enrollment targets are met.
• Monitored site metrics and achieved recruitment milestones for multiple clinical trials, ensuring timely enrollment of participants at key study sites.

• Led the submission, indexing, and quality control (QC) review of clinical trial documents, ensuring compliance with regulatory standards, and maintaining the integrity of the Trial Master File (TMF).
• Successfully set up, maintained, and managed the TMF, conducting ongoing and final QC checks to guarantee the accuracy and completeness of documents. Provided actionable feedback to ensure the TMF met the highest standards of quality and compliance.
• Expertly reviewed and organized key clinical study documents (e.g., 1572s, CVs, IRB-IEC documents such as approvals, renewals, membership lists, and study agreements), ensuring all documents were in proper order and readily accessible.
• Maintained accurate tracking and reporting of study metrics, enabling clear visibility into project progress, and ensuring timely execution.
• Developed spreadsheets, trackers, presentations, and other documents tailored to meet the specific needs of each trial, improving workflow efficiency, and supporting team success.
• Diligently monitored and communicated project progress, ensuring strict adherence to deadlines, and promptly addressing any issues that could impact timelines.
• Trained and mentored new hires on clinical research fundamentals, including DIA eTMF, essential documents, and regulatory requirements, fostering a knowledgeable and cohesive team.
• Applied expert knowledge of Good Clinical Practice (GCP), International Council for Harmonization (ICH) guidelines, and local regulatory requirements to ensure full compliance in all trial-related activities.
• Managed and maintained clinical trial management systems (CTMS, ELVIS, SharePoint, and Wingspan), ensuring accurate and timely data entry and retrieval.
• Utilized advanced Microsoft Office Suite skills (Word, Excel, Outlook, PowerPoint) to support document creation, data analysis, and effective communication within the team.
• Ensured the TMF remained inspection-ready at all times by implementing rigorous document management practices, ensuring compliance with regulatory guidelines, and facilitating smooth audit processes.