Hire Poonam

Poonam Kale

Clinical Research and Study Delivery Specialist

Dynamic Clinical Research and Study Delivery Specialist with 9+ years of experience in global pharmaceutical and CRO environments, specializing in project management, TMF operations, and study documentation. Expertise spans Phase II–III clinical trials, inspection readiness, and vendor oversight. Skilled in study startup, conduct, and closeout, ensuring compliance with ICH-GCP and regulatory standards. Strong proficiency in eTMF systems (Veeva Vault, Wingspan, ELVIS) and study delivery tools including Study Maestro, FIORI, and IQVIA Clinical Trial Payments. Recognized for driving operational excellence, process optimization, and cross-functional team leadership.

FORMERLY AT

GSK

LOCATION

Bengaluru, India

AVAILABILITY

Full-time

Skills

Work Experience

Study Delivery Specialist

GSK

Jul 2022 – Present

Lead startup and closeout activities for multiple global studies ensuring timely TMF delivery.
Manage TMF quality, archival, and inspection readiness for assigned clinical programs.
Oversee country management, feasibility, and budget tracking using IQVIA Clinical Trial Payments tool.
Perform unblinded study management, data quality review, and TMF completeness checks.
Serve as Scrum Master for STOM projects, facilitating sprint planning and stakeholder coordination.
Conduct TMF compliance training sessions for internal teams.
Collaborate with vendors and study leads for audit preparation and risk mitigation

TECHNOLOGIES

Centralized Study Specialist I

Covance (Labcorp)

Feb 2020 – Jul 2022

Supported global studies through document collection, processing, and TMF inspection readiness.
Assisted study management teams with system updates, metrics tracking, and budget reporting.
Monitored KRIs and coordinated vendor and site contracts for study conduct.
Maintained CTMS, EDC, and IWRS systems ensuring data accuracy.
Conducted team meetings, documented MOMs, and ensured on-time deliverables per SOP.
Recognized for TMF quality contributions and high-volume document processing (20,000+ docs in 30 days).

TECHNOLOGIES

IQVIA

Sep 2015 – Feb 2020

Led TMF health checks, CAPA implementation, and audit readiness for global studies.
Supported root cause analysis and TMF data correction.
Worked with study teams to resolve audit findings and ensure full TMF completeness.
Contributed to TMF metric reporting and sponsor communication for inspection preparation
Served as backup TMF Lead managing a team of 15 associates.
Oversaw TMF delivery compliance, document reconciliation, and study metrics reporting
Coordinated with study leads and QA for TMF process improvements.
Managed document logs, study trackers, and TMF metrics dashboards.
Supported document filing, quality control reviews, and study archiving.
Ensured all clinical documentation met ICH-GCP and sponsor requirements