Job Description
Join our pioneering team at Global Health Innovations, where we're revolutionizing patient care through cutting-edge medical research. As a Senior Clinical Research Manager, you'll lead pivotal trials that directly impact global healthcare outcomes. We offer a dynamic, collaborative environment with state-of-the-art facilities and opportunities for professional growth in one of the world's most innovative medical hubs.
Responsibilities
- Design and oversee end-to-end clinical trial protocols ensuring FDA/ICH compliance
- Manage cross-functional teams including physicians, biostatisticians, and regulatory affairs specialists
- Analyze complex clinical data and generate actionable insights for therapeutic development
- Collaborate with pharmaceutical partners on trial feasibility and budget optimization
- Implement risk-based monitoring strategies to enhance trial efficiency
- Maintain strict ethical standards and patient safety protocols throughout studies
- Present findings to regulatory bodies and executive stakeholders
Qualifications
- Master's degree in Clinical Research, Life Sciences, or related field (PhD preferred)
- 8+ years of clinical trial management experience in therapeutic areas (oncology/cardiology focus)
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Deep understanding of GCP, FDA 21 CFR Part 312, and ICH-GCP guidelines
- Strong leadership skills with experience managing global, multi-site trials
- Exceptional data interpretation and statistical analysis capabilities
- Excellent communication skills for stakeholder engagement and regulatory submissions