Job Description
Join our pioneering team at BioPharm Innovations Inc., a leader in cutting-edge pharmaceutical research, as we develop breakthrough therapies to transform global healthcare. We seek a dynamic Senior Clinical Research Manager to oversee complex Phase II-III clinical trials, ensuring regulatory compliance and driving innovation in drug development. This role offers the opportunity to lead cross-functional teams and contribute to life-changing medical advancements in a collaborative, fast-paced environment.
Responsibilities
- Design and execute global clinical trial protocols in accordance with ICH-GCP guidelines
- Lead cross-functional teams including CRAs, data managers, and biostatisticians
- Ensure FDA compliance and manage regulatory submissions
- Monitor trial progress, resolve site issues, and maintain trial master files
- Analyze clinical data and prepare study reports for regulatory agencies
- Collaborate with medical affairs to ensure scientific integrity
- Represent the company at investigator meetings and industry conferences
Qualifications
- Master’s degree in Pharmacy, Life Sciences, or related field (PhD preferred)
- 8+ years of clinical research experience with 3+ years in leadership roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in managing Phase II-III trials in therapeutic areas (Oncology/CNS preferred)
- Strong knowledge of FDA regulations, ICH-GCP, and global clinical trial standards
- Exceptional project management and stakeholder communication skills
- Experience with EDC systems (e.g., Medidata Rave) and risk-based monitoring