Bibi Ramkellawan
Global Project Manager/Director|SCRA|Clinical Ops
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About
Engaging and results-driven clinical research executive with 20+ years of experience managing and leading clinical trials across a wide range of therapeutic areas.
Former Registered
Nurse with 5+ years of nursing experience and over a decade in senior leadership roles within pharma, biotech, CROs, healthcare and non-profits. Deep expertise in GCP, ICH, global regulations. Proven ability to lead cross-functional teams, drive regulatory strategy and deliver high-quality outcomes across healthcare, non-profit organizations and clinical trials both non interventional and interventional with novel drugs, medical devices, biologics, and digital health interventions.
Experience
- Clinical Trial Operations & Oversight (inc. Project Management and CRA)
- Regulatory Compliance
- Risk-Based Monitoring & Audits
- Vendor/CRO Management
- SOP & Policy Development
- Strategic Leadership & Mentorship
- Real-World Evidence (RWE) Studies
- Participant Engagement, Recruitment and Retention
- Therapeutic Expertise: Oncology, Ophthalmology, Rare Diseases, CNS, Dermatology, Gastroenterology, Respiratory, Endocrinology, and more
Education
Nursing Program Graduate & previous experience teaching clinical research programs at the college and university level
