Divyashree S

Experienced Clinical Data Management Team Lead with over 8+ years of expertise in Clinical Data Management and Database Services.

I specialize in clinical trial data management, EDC systems, and cross-functional team leadership, with a proven ability to manage end-to-end clinical database activities while ensuring compliance with FDA and ICH guidelines. Skilled at optimizing project timelines and resource utilization, I excel in driving efficiency and delivering high-quality outcomes. As a strong communicator and strategic problem solver, I have successfully led global teams, enhanced operational processes, and contributed to the success of numerous clinical trials. Committed to continuous improvement, I consistently strive to exceed quality standards and advance excellence in clinical research.

Lead a team of EDC programmers, defining and prioritizing resource requirements.
Manage resource assignments across projects to ensure high-quality delivery of clinical database services.
Foster collaboration by managing internal and external negotiations to create a positive team environment.
Enable effective communication and optimize resource utilization to meet study timelines and contractual obligations.
Assist in monitoring project scope, timelines, budgets, and milestones while managing issues and risks across various projects.
Identify potential study risks, implement mitigation strategies, and escalate issues as necessary.
Collaborate with Data Management Delivery Leads to maintain CDM systems and deliverables.
Track milestone achievements, manage data transfer agreements, and address study administrative needs.
Provide oversight for Trial Master File compliance to ensure audit readiness, including maintaining expected document lists and conducting quality compliance checks.
Assist in resolving issues related to Clinical Data Management deliverables and contribute ideas for continuous improvement.
Provide expert review and guidance for the production of Data Management deliverables, including CRF/e-CRF design, database setup, validation programming, change requests and Data Management Plans.
Ensure task performance meets or exceeds quality standards, sponsor/client expectations, and regulatory guidelines.
Train new hires and provide ongoing guidance to existing team members on standards, process guidelines, and SOPs to improve team proficiency and support professional development initiatives.
Perform other duties, assignments, or special projects as required by project needs or organizational priorities.

Master of Computer Applications