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Bibi Ramkellawan

Bibi Ramkellawan

Global Project Manager/Director|SCRA|Clinical Ops

Pharmaceutical / Bio-tech

Toronto, Ontario

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Services offered

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.

Clinical research executive
Clinical trial manager
Project manager
Registered nurse
Regulatory compliance
Approximate rate: CAD$ 150 per hour

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 

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