Job Description
Join BioGenix Pharmaceuticals, a global leader in innovative therapeutics, as a Senior Clinical Research Associate. You will be pivotal in advancing groundbreaking treatments through rigorous clinical trials. Our Cambridge hub offers state-of-the-art facilities and a collaborative environment where science meets business excellence. Enjoy competitive compensation, comprehensive benefits, and opportunities to shape the future of medicine.
Responsibilities
- Design, implement, and monitor global clinical trials ensuring GCP/ICH compliance
- Liaise with investigative sites to optimize trial execution and data integrity
- Analyze clinical data and prepare regulatory submissions for FDA/EMA
- Lead cross-functional teams including biostatisticians and medical writers
- Develop risk-based monitoring strategies and site management plans
- Mentor junior CRAs and contribute to process improvements
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified CRA (CCRA) or equivalent certification
- Expertise in oncology or rare disease therapeutic areas
- Proficiency in EDC systems (e.g., Medidata Rave) and CTMS
- Strong regulatory affairs knowledge (FDA/EMA guidelines)
- Exceptional problem-solving and stakeholder management skills