Job Description
Join BioVita Therapeutics at the forefront of pharmaceutical innovation as a Senior Clinical Research Associate. You will lead pivotal clinical trials that transform patient lives, working with cutting-edge therapies in our state-of-the-art Cambridge facility. This role offers unparalleled opportunities to shape the future of medicine while collaborating with world-class scientists and regulatory experts.
Responsibilities
- Design and execute clinical trial protocols ensuring GCP/ICH compliance
- Monitor investigational sites, conduct audits, and resolve protocol deviations
- Lead cross-functional teams including biostatisticians and medical writers
- Manage regulatory submissions and interact with FDA/EMA authorities
- Analyze clinical data and prepare safety/efficacy reports
- Mentor junior CRAs and optimize clinical trial workflows
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field
- 5+ years of clinical research experience in pharmaceuticals
- Certified CRA (ACRP/SoCRA) preferred
- Expertise in oncology or rare disease trials
- Strong proficiency in EDC systems (e.g., Medidata Rave)
- Proven track record of leading multi-center trials
- Exceptional data interpretation and regulatory affairs skills