Job Description
Join Global Health Innovations as a Senior Clinical Research Manager and lead groundbreaking medical trials that transform patient care. We're seeking a visionary professional to oversee complex clinical studies in oncology and rare diseases, ensuring regulatory compliance and data integrity while collaborating with top-tier medical institutions. Enjoy competitive compensation, comprehensive benefits, and the opportunity to shape the future of healthcare innovation.
Responsibilities
- Design and implement comprehensive clinical trial protocols adhering to FDA and ICH guidelines
- Manage cross-functional teams including physicians, data analysts, and regulatory specialists
- Oversee site selection, monitoring, and audit processes for multi-center trials
- Develop and maintain robust risk mitigation strategies for clinical operations
- Ensure timely submission of regulatory documents and maintain trial master files
- Analyze complex clinical data and prepare comprehensive study reports for stakeholders
- Represent the company at regulatory meetings and scientific conferences
Qualifications
- Master's degree in Life Sciences, Nursing, or related field (PhD preferred)
- 8+ years clinical research experience with 3+ years in leadership roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record managing Phase II-III oncology or rare disease trials
- Expertise in EDC systems (e.g., Medidata Rave) and clinical trial management
- Demonstrated success with FDA audits and regulatory submissions
- Strong knowledge of GCP and international regulatory frameworks
- Exceptional project management and stakeholder communication skills