Job Description
Join our pioneering team at Pfizer Global R&D in Cambridge, where innovation meets impact. We seek a Senior Clinical Research Associate to lead complex Phase II-III oncology trials, shaping the future of cancer therapeutics. Collaborate with cross-functional teams to ensure protocol compliance, data integrity, and regulatory adherence while mentoring junior staff. This hybrid role offers competitive benefits, cutting-edge resources, and the opportunity to contribute to breakthrough treatments.
Responsibilities
- Design and execute clinical trial protocols for oncology studies
- Monitor site performance and ensure GCP compliance
- Analyze clinical data and prepare regulatory submissions
- Lead cross-functional meetings with biostatistics and medical teams
- Mentor junior associates and optimize trial processes
- Manage investigator relationships and site selection
- Develop risk-based monitoring strategies
Qualifications
- MS/PhD in Life Sciences with 5+ years CRO/pharma experience
- Certified CRA (ACRP/SoCRA) preferred
- Expertise in oncology clinical trial management
- Proficiency in EDC systems (Medidata Rave)
- Strong FDA/ICH-GCP regulatory knowledge
- Proven leadership in multi-center trials
- Exceptional data management and audit skills
- Excellent cross-cultural communication abilities