Over 9 years of experience as a Clinical Research lead and Clinical Trial Expert with a proven history of overseeing clinical trials from initiation to completion. Expert in project management, regulatory compliance, and team coordination, ensuring adherence to ICH- GCP, FDA and EMA guidelines and regulations. Skilled in developing study documents e.g. protocols and patient-facing documents, managing budgets and leading cross-functional teams to achieve project milestones on time and within budget. Adept at risk management, problem-solving, data analysis, consistently delivering high-quality results. Experience also in risk-based, traditional, and remote monitoring, Phase I-IV oncology, immune-oncology trials and radiolabeled trials, CNS, Cardiovascular, Dermatology, and Rare disease. Shows teamleadership, flexibility, dependability, and interpersonal skills in multiple complex trials simultaneously.SKILLS- Adaptability and willingness to embrace new protocols and tasks - Sound knowledge of medical terminology, FDA, EMA and ICH-GCP guidelines.- Strong problem-solving skills and critical thinking abilities- Proficient in performing rigorous data verification and quality control checks to ensure accuracy and integrity.-Ability to lead cross-functional teams and lead multiple projects efficiently- Capable of managing large study budgets and keeping study within budget- Skilled in developing, reviewing and improving Standard Operating Procedure (SOPs) protocols and other study documents to optimize study processes.- Ability to identify, manage and evaluate multiple vendors and study sites and maintain relationships for future endeavors.-Proficient in Office 365 and various trial software e.g. CTMS, IRT, TMF, EDCStrong interpersonal skills for effective collaborations.