Job Description
Join our pioneering team at NovoGen BioPharmaceuticals, where innovation meets therapeutic breakthroughs. We're seeking a Senior Clinical Research Associate to lead critical Phase I-III clinical trials, ensuring data integrity and regulatory compliance while advancing next-generation therapies. Work alongside world-class scientists in our state-of-the-art Cambridge facility, where your expertise will directly impact patient outcomes and drug development timelines.
Responsibilities
- Design, implement, and monitor global clinical trial protocols in oncology and rare disease therapeutics
- Conduct site visits, audits, and vendor management to ensure GCP/ICH compliance
- Oversee data collection, analysis, and report generation for FDA submissions
- Mentor junior CRAs and cross-functional teams in clinical operations excellence
- Collaborate with regulatory affairs to prepare IND/IMPD documentation
- Lead risk-based monitoring strategies and eCRF validation processes
- Present trial progress and safety findings to executive stakeholders
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field with 5+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in clinical trial management systems (e.g., Veeva Vault RIM)
- Strong understanding of FDA E6(R2) and ICH-GCP guidelines
- Exceptional data management and statistical reporting skills
- Experience leading cross-functional teams in matrix environments
- Excellent written and verbal communication abilities