Headline

TMF Associate at Fortrea | Improving Clinical Data Efficiency

About

Experienced TMF Specialist with expertise in clinical trial data management and regulatory compliance, complemented by strong skills in team coordination and stakeholder communication. Proven track record in leading data operations and managing complex documentation workflows to ensure accuracy, audit readiness, and adherence to timelines. Adept at resolving discrepancies, optimizing processes, and using industry tools such as Veeva. Known for fostering collaborative environments, driving continuous improvement, and demonstrating strong organizational and leadership capabilities. Committed to maintaining data integrity and supporting compliance across clinical and operational functions.

Location

Thane

Work experience

Clinical Operations Specialist at Fortrea, Aug 2022 - Present · 3 yrs 10 mos, Bengaluru, Karnataka, India, • Improved data management efficiency by organizing and standardizing document workflows within the TMF, resulting in a 25% reduction in document retrieval time and ensuring 100% audit readiness. • Led data review processes, identifying and resolving data discrepancies, ensuring 95% data accuracy across all studies. • Managed regulatory compliance for multiple clinical trials, adhering to industry standards (ICH-GCP), ensuring 100% compliance during audits. • Collaborated with cross-functional teams using Veeva, SAS, and SQL for comprehensive data tracking and clarifications, enhancing overall project efficiency by 20%. • Mentored junior staff on best practices in document management and data review, improving team performance and reducing onboarding time by 30%.

Process Associate at Tata Consultancy Services, Dec 2019 - Aug 2022 · 2 yrs 9 mos, Pune Division, Maharashtra, India, • Performed comprehensive data reviews for pharmaceutical documents, ensuring timely resolution of data clarifications, contributing to the successful completion of projects within stringent timelines. • Maintained regulatory compliance by conducting thorough reviews of documents according to SOPs, meeting client SLAs, and maintaining a 100% track record for timely document submissions. • Conducted quality checks and managed database discrepancies, ensuring consistent adherence to regulatory requirements and reducing document errors by 15%. • Identified process improvement opportunities through trend analysis, which resulted in streamlined document management processes, improving efficiency by 10%.

Education

Master of Business Administration - MBA, Human Resources Management/Personnel Administration, General, Savitribai Phule Pune University

Bachelor of Pharmacy - BPharm, Pharmacy, shivaji university