Dynamic SR Clinical Trial Manager with more than 20 years of experience in the industry. With 6 years in the role of Clinical Trial Manager (or a similar position) and 11 years as a Clinical Research Associate, I have effectively overseen and executed numerous clinical research programs, ranging from First-in-Human Phase I studies to late-stage Phase IV trials across various therapeutic areas, including both device and drug trials. I have a proven track record of leading cross-functional teams, ensuring compliance with regulatory requirements, and delivering high-quality results within set timelines and budgets. My expertise includes clinical trial management, vendor oversight, risk assessment, and prioritizing patient safety. I have experience in directing CRA teams, developing project strategies, and implementing process improvements that enhance trial efficiency and outcomes. I am recognized for fostering collaborative work environments, maintaining rigorous ethical standards, and driving innovative solutions to complex challenges.
Clinical Trial Management Role:
CRA Monitoring Management Role:
Assign CRA sites, maintain CRA metrics per KPIs, review visit reports for training purposes, conduct annual or biannual quality training, and document monthly CRA performance for annual merit increases.
Hold 1:1 calls with CRAs to discuss career path progression, performance, and provide oversight.
Participate in weekly leadership calls to align on study and team objectives.
Maintain and monitor two (2) sites as a Senior CRA to ensure quality, and stay attuned to real-time site activities for effective leadership.
Submit and track documents to the central IRB for regulatory compliance.
Routinely review, reconcile, and collect documents for the Investigator Site File (ISF), including IRB submissions, safety, and protocol deviation reporting, as applicable.
Manage data entry, resolve queries, and address action items efficiently.
Perform 100% source data verification (SDV), and apply risk-based monitoring models as appropriate.
Manage and track study FAQs to support site and team inquiries.
Manage and track submissions to the central reader/core lab for study assessments.
Develop and distribute study newsletters to keep stakeholders informed.
Organize and participate in Principal Investigator (PI) and Study Coordinator (SC) meetings.
Liaise with Medical Science Liaisons (MSLs) for site visits and scientific support.
Project Management Certificate
Coursera
April 2025
ISO14155 Certificate
Clinical Pathways
04April 2025
GCP/ICH Certificate
NIDA Clinical Trials Network
01April 2024 to 01Apr2027
ECG Techniques & Phlebotomy Certificates
05January 2000