Job Description
Join BioVital Therapeutics at the forefront of pharmaceutical innovation as a Senior Clinical Research Manager. Lead pivotal clinical trials for groundbreaking therapies in oncology and immunology, collaborating with cross-functional teams to accelerate drug development. Enjoy competitive compensation, comprehensive benefits, and the opportunity to shape the future of medicine in a dynamic, research-driven environment.
Responsibilities
- Design and execute global clinical trial protocols ensuring FDA/EMA compliance
- Manage cross-functional teams including CRAs, biostatisticians, and medical writers
- Oversee site selection, monitoring, and vendor relationships
- Analyze clinical data and prepare regulatory submissions (IND/BLA)
- Present trial outcomes to senior leadership and regulatory authorities
- Maintain budget oversight for assigned clinical programs
Qualifications
- PhD or PharmD in Life Sciences with 5+ years clinical research experience
- Proven expertise in oncology/immunology therapeutic areas
- ICH-GCP certification and strong regulatory knowledge
- Advanced proficiency in eCRF systems and clinical databases
- Exceptional project management and stakeholder communication skills
- Experience managing Phase II-III trials with 20+ sites