Job Description
Join BioVita Innovations at the forefront of pharmaceutical innovation as a Senior Clinical Research Manager. Lead pivotal clinical trials that transform patient lives while collaborating with world-class scientists and regulatory experts. We offer a dynamic environment where your expertise directly impacts groundbreaking therapies. Competitive compensation, comprehensive benefits, and career advancement opportunities await.
Responsibilities
- Design and execute global Phase II-III clinical trials with strict adherence to GCP and FDA regulations
- Lead cross-functional teams including physicians, data scientists, and regulatory affairs specialists
- Oversee clinical site management, monitoring, and vendor relationships
- Develop comprehensive clinical trial protocols and ensure regulatory compliance
- Analyze complex trial data and prepare regulatory submissions for FDA/EMA approval
- Mentor junior research staff and drive continuous process improvements
Qualifications
- PhD or PharmD in life sciences with 8+ years clinical research experience
- Proven track record managing oncology/neurology trials preferred
- ICH-GCP certification and deep knowledge of FDA/EMA regulations
- Expertise in EDC systems (e.g., Medidata Rave) and risk-based monitoring
- Exceptional leadership and stakeholder management skills
- Published research in peer-reviewed journals highly valued