Uthra Lavanya Ramesh

• Leading a team of highly experienced employees Pan India, setting and tracking SMART goals aligned with department and client requirements.
• Organized frequent meetings to strategize individual enhancements, nurturing team initiative and motivation
• Implemented quality-driven processes that elevated team performance and efficiency maintaining a highly motivated workforce.
• Revitalized employee training programs, effectively closing knowledge gaps and elevating overall group performance.
• Collaborated cross-functionally to identify and resolve process-related gaps, fostering an environment of open communication.
• Delegated work to meet daily deliverables, ensuring effective resource allocation and task prioritization.
• Regularly reviewed performance, conducted improvement plans, and provided ongoing support for employee development.
• Successfully centralized the TMF process from Clinical Operations to India, reducing FTE involvement by 75% and improving turnaround times by 50%.
• Spearheaded audits and inspections, managing preparations, training, and timely implementation of CAPAs.
• Established a centralized team for 80% of TMF Lead processes from start up phase to close out phase of TMF , resulting in increased efficiency and significant FTE savings.
• Collaborated with critical stakeholders and clients, adapting to changes and driving continuous process and system improvements.
• Provided tailored support to clients through focus sessions, customized metrics reports, and action item tracking.
• Ensured accurate billing and budget tracking by reviewing study contracts and proactively addressing over-burn issues.
• Pioneered Robotic Process Automation and Artificial Intelligence initiatives related to Quality Review Checks, TMF completeness and TMF Inspection Readiness.
• Led successful system integration projects , identifying enhancements and driving their implementation.
• Managed UAT for system up-gradation, closely collaborating with the Systems team to ensure seamless transitions.
• Leading the Company specific TMF Index update and maintenance to align with Company requirements, Sponsor expectations and Industry standards.

• Managed a team of new and experienced TMF Specialists across scanning, QC, Indexing, Quality Review and Expert QC process.
• Cultivated a process improvement culture as Group Lead, optimizing efficiency and value for the business and clients.
• Managed resourcing of the staff, ensuring adherence to established processes and quality standards, meeting operational and sponsor expectations.
• Provided leadership, goal setting, and mentoring for a motivated and innovative team.
• Aligned with ICON's values and contributed to a culture of process enhancement and client-focused approach.
• Supported and mentored TMF Specialists, ensuring ongoing technical assistance.
• Oversaw TMF Specialist teams, ensuring productivity, quality targets, and performance metrics were achieved.
• Collaborated with TMF Specialist groups to resolve indexing and filing errors, adapting processes based on pilot results.
• Represented TMF Operations in audits, managing findings within the Quality Management System.
• Managed performance of TMF Specialists, meeting timeliness, budget, and quality standards.
• Escalated human resource issues and controlled absenteeism.
• Acted as Subject Matter Expert for TMF Specialist activities, supporting TMF Leads, Internal stakeholders and timely issue resolution.
• Supported on Integration projects as Subject Matter Expert on the process.

• Led the setup and maintenance and close out of the Study in ICON's and Sponsor's TMF system, ensuring seamless documentation management.

• Drove TMF completeness and quality throughout the trial duration overseeing documentation flow within projected timelines.

• Managed TMF activities within contracted budgets, successfully ensured TMF closure within study timelines.

• Developed and nurtured sponsor relationships through effective TMF management and communication. Received recognition from Client related to successful establishment of TMF process that met Client's requirement.

• Ensured smooth internal and external audits of study TMF-related queries, preparing robust audit and inspection responses.

• Provided transparent monitoring and reporting of TMF progress to stakeholders, facilitating effective communication among study teams. • Applied lessons learned to enhance documentation management practices, promoting continual improvement across study teams.

• Educated and guided Study Teams, TMF leads, and TMF specialists, fostering awareness of good document management practices.

• Collaborated across Functional Lines to maintain accurate Study Specific Document Lists (SSDLs) and enhance document quality.

• Ensured ownership and accountability of TMF documents, meeting quality metrics and driving efficient processes.

• Engaged in Company/Departmental initiatives, contributing to broader organizational goals.

• Mentored new employees in TMF Lead tasks and duties, demonstrating commitment to team development.

• Performed the role of Project Manager for an Observational study in South Africa, which includes managing the team in South Africa, working on contracts and change orders, time management, tracking of out of scope activities, vendor management, project finance management, managing contracted resources, budget negotiation with Client, time sheet and expense approvals, resource/budget forecast, report review etc.
• Performed the role of a Lead CRA for Phase II study conducted in India, KSA, Turkey and Egypt which involved managing the overall study conduct, interaction with client, report reviews, resource management, conducting internal team meetings, targeting milestones etc
• The study goal was met within the stringent timelines allocated by the Sponsor for which I received Sponsor and Senior Management appreciation for the quality of the work performed
• Assisted managers with the project management activities for UAE based projects which includes report reviewing activities
• Have gained experience on several BA/BE studies monitoring activities, which helped me to gain knowledge on the activities involved for bio-similar studies
• Mentored CRAs and CTAs to meet the standards of monitoring and study related in-house activities, respectively
• Additionally have performed roles of designing and reviewing SOPs related to monitoring, contracts and budgets and few project management activities
• Received the best employee award within 2 months of joining the Organization (Oct 2012) and has been nominated for the award twice between the years 2014-2015

• Performed the start-up trial activities in USA for an Oncology study, which included conducting 7 Pre study visit within a period of 2 weeks
• Have worked from the US office (Wilmington, NC) for a period of 2 months assisting the team in FDA audit preparation and Start up activities for several oncology projects
• Worked as contracted Project Manager for an endocrinology study (phase III) based in India with activities involving study progress tracking, accompanied site visits with study team and report review
• Performed several global feasibility study of sites based in USA, Singapore, Germany, Israel, Italy, Netherlands and UK
• Assisted with reviewing reports for studies based in UK and USA and liaised with Project managers in discussion of the site specific issues
• Worked as an associate project manager for a study based in European Countries which involved review of reports at an average of 4 per day
• Have coordinated with CRAs to identify site specific issues, tracked study progress and identified risks related to achievement of milestones etc.
• Worked as a part of Task Force formed by the Organization to set up modules to train global CRAs.

• Performed all site related activities starting from site identification, feasibility, evaluation, selection, initiation, monitoring and close out
• Performed overall site management based on the study specific needs
• Designed patient information sheets and informed consent forms as per Country regulation
• Ensured timely submission of protocol/consent documents for ethics/IRB approval
• Conducted regular monitoring visits in accordance with the site monitoring SOP
• Maintained all files and documentation pertaining to the trial
• Completed visit reports and follow up letter in a timely manner, as per study requirements
• Coordinated with data management, pharmacovigilance and IVRS team for study related needs
• Have faced internal QA and Sponsor audits without any major observations
• Conducted and organized Investigator Meetings within India as well as abroad
• Worked as a CTA for a multinational trial and involved in tasks such as tracking study progress, compilation of deviations and issues tracker, submitted regular updates to project managers, assisted CRAs in study related activities etc.
• Awards and Achievements:
• Won the Best employee award in the month of August 2015, at ClinTec (India) International Pvt
• Ltd., and have been nominated for this award twice in the year 2015
• Has won the ICO100 award for the year 2008, at ICON Clinical Research India Pvt
• Ltd., for best performance
• Have also been nominated for the same award in the year 2009
• Successfully managed 10 sites simultaneously with the load of more than 750 patients from 4 sites for cardiovascular indication
• Monitored and managed the top recruiting sites in the World for cardiovascular indication with over 300 patients from one Investigative site
• Successfully managed more than 10 sites for Oncology trial, of which 50% of sites were top recruiters in India
• Successfully managed the retrieval of the trial data from all the sites within the proposed timelines.