Job Description
Join BioPharm Innovations, a global leader in groundbreaking pharmaceutical research, as we pioneer next-generation therapies. We seek a meticulous Senior Clinical Research Associate to orchestrate complex clinical trials and ensure regulatory compliance while advancing medical innovation. Work in our state-of-the-art Cambridge facility alongside world-class scientists to transform promising discoveries into life-changing treatments.
Responsibilities
- Design, implement, and monitor Phase I-IV clinical trials across therapeutic areas
- Ensure adherence to FDA, EMA, and ICH-GCP guidelines throughout trial lifecycle
- Lead site initiation, monitoring, and closeout activities with 15+ global sites
- Analyze clinical data and prepare comprehensive regulatory submissions
- Mentor junior CRAs and optimize clinical trial protocols
- Collaborate with cross-functional teams (biostatistics, medical affairs, regulatory affairs)
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field (PhD preferred)
- 5+ years of clinical research experience with 2+ in CRA roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced knowledge of electronic data capture systems (e.g., Medidata Rave)
- Exceptional audit preparation and risk management skills
- Strong proficiency in SAS or R for clinical data analysis