Job Description
Join BioVita Therapeutics, a leader in innovative oncology therapeutics, as we accelerate breakthrough treatments for global markets. We seek a dynamic Senior Clinical Research Manager to lead complex Phase II-III trials, ensuring regulatory compliance and scientific excellence. This hybrid role offers the opportunity to shape clinical development strategies while collaborating with cross-functional teams in our state-of-the-art Boston facility.
Our ideal candidate thrives in fast-paced environments, possesses deep GCP expertise, and is passionate about translating scientific innovation into patient outcomes. BioVita offers competitive compensation, comprehensive benefits, and a culture that champions professional growth.
Responsibilities
- Design and execute global clinical trial protocols for oncology therapeutics
- Lead cross-functional teams (CRA, biostatistics, medical affairs) to ensure trial milestones
- Oversee regulatory submissions (IND/CTA) and maintain FDA/EMA compliance
- Analyze clinical data and prepare regulatory documentation (IBRs, DSURs)
- Manage vendor relationships and clinical trial budgets
- Mentor junior CRMs and implement process improvements
Qualifications
- MS/PhD in Life Sciences with 8+ years clinical research experience
- Proven track record in managing oncology Phase II-III trials
- ICH-GCP/21 CFR Part 312 expertise
- Certified Clinical Research Professional (CCRP) required
- Strong SAS programming and data interpretation skills
- Experience with EDC systems (Medidata Rave preferred)
- Exceptional leadership and stakeholder management abilities