Key Responsibilities
- Lead and manage Phase I–IV clinical trials in Sickle Cell Disease from study start-up through closeout.
- Develop and oversee study timelines, budgets, and project plans.
- Coordinate cross-functional teams including Clinical Operations, Data Management, Biostatistics, Statistical Programming, Medical Writing, Pharmacovigilance, and Regulatory Affairs.
- Manage CROs, vendors, and external partners to ensure study milestones are achieved.
- Identify project risks and implement mitigation strategies.
- Monitor study progress, enrollment, timelines, and deliverables.
- Conduct project meetings and provide regular updates to sponsors and senior management.
- Ensure compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
- Review study documents including protocols, informed consent forms, monitoring plans, and study reports.
- Support database lock, clinical study report activities, and regulatory submissions.
- Maintain effective communication with investigators, sites, sponsors, and internal stakeholders.
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field (Master's degree preferred).
- 8+ years of clinical research experience.
- 3+ years of experience as a Clinical Project Manager.
- Demonstrated experience managing Sickle Cell Disease clinical trials.
- Experience with global, multicenter clinical studies.
- Strong understanding of ICH-GCP, FDA, EMA, and clinical trial regulations.
- Excellent leadership, communication, organizational, and problem-solving skills.
Preferred Experience
- Experience in Rare Diseases, Hematology, Gene Therapy, or Cell Therapy.
- Sponsor or CRO experience.
- Experience supporting NDA/BLA regulatory submissions.
Pay: $80,000.00-$90,000.00 per year
Education:
- Bachelor's Degree (preferred)
Experience:
- Clinical research: 8 years (required)
- Clinical Project Manager: 3 years (required)
- sickle cell disease: 1 year (preferred)
Work Location: Remote
