Job Description
Join BioVita Innovations, a leader in pioneering biopharmaceutical solutions, as we revolutionize patient care through groundbreaking clinical trials. We're seeking a dynamic Senior Clinical Research Manager to spearhead our Phase II-III oncology studies in a cutting-edge environment. Collaborate with cross-functional teams to deliver life-changing therapies while maintaining GCP compliance and regulatory excellence. Enjoy competitive compensation, comprehensive benefits, and the opportunity to shape the future of medicine.
Responsibilities
- Oversee end-to-end clinical trial execution for Phase II-III oncology studies
- Lead cross-functional teams (CRA, biostatistics, data management) to ensure protocol compliance
- Develop and maintain robust risk-based monitoring strategies
- Manage clinical trial budgets and vendor relationships
- Prepare regulatory submissions and interact with FDA/EMA authorities
- Implement innovative eClinical technologies (ePRO, RAVE EDC)
- Mentor junior staff and drive process optimization
Qualifications
- MS/PhD in life sciences or related field with 8+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent
- Proven track record in oncology/immunology trials
- Expertise in ICH-GCP, FDA, and EMA regulations
- Strong leadership and project management skills
- Experience with electronic health records and RAVE EDC systems
- Exceptional problem-solving and stakeholder communication abilities