
Accomplished clinical research professional with extensive expertise in clinical trials management and a strong focus on patient safety and study protocol compliance. Demonstrates proficiency in MHRA regulations, pharmacovigilance, and ethical oversight, ensuring rigorous adherence to regulatory standards. Skilled in data analysis, risk assessment, and effective communication, facilitating seamless team collaboration and decision-making processes. Adept at managing early phase trials and first-in-human studies, with a proven track record of successful REC submissions and regulatory submissions. Committed to advancing clinical research through evidence-based practices and continuous professional development.
Clinical Trials Management I Research Ethics I MHRA Regulations I Protocol Review I Investigator Brochure Review I Consent Form Review I Study Manual Review I Physical Examination I Lab Work Review I ECG Review I Cardiac Safety Trials I DDI Trials I Data Analysis I Dose Escalation I Adverse Event Management I Clinical Evaluation I Case Report Form Review I Study Reporting I Clinical Research I Patient Safety I Study Protocol Compliance I Risk Assessment I Medical Documentation I Patient Interaction I Team Collaboration I Trial Oversight I Evidence Analysis I Team Leadership I Decision Making I Effective Communication I Time Management I People Management I Risk Management I Pharmacovigilance I REC Submissions I Regulatory Submissions I Study Report Review I Safety Meetings I Early Phase Trials I First in Human Trials I In-Depth knowledge of GCP