Job Description
Join NovoGen Therapeutics, a leader in innovative oncology therapeutics, as we pioneer next-generation treatments that transform patient lives. We seek a dynamic Senior Clinical Research Manager to spearhead our Phase II-III clinical trials, ensuring regulatory compliance and scientific excellence. This pivotal role bridges cutting-edge research with real-world patient impact in our state-of-the-art Cambridge facility.
Responsibilities
- Design, execute, and oversee complex multi-center clinical trials from protocol development to final reporting
- Lead cross-functional teams including physicians, data scientists, and regulatory affairs specialists
- Ensure strict adherence to GCP, FDA, and ICH guidelines throughout trial lifecycle
- Collaborate with global partners to drive strategic clinical development plans
- Manage trial budgets, timelines, and vendor relationships
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approval
Qualifications
- PhD or PharmD in Life Sciences with 8+ years clinical research experience
- Proven track record leading Phase II-III oncology trials
- Expertise in regulatory strategy and global submission processes
- Strong proficiency in clinical data management systems (e.g., Medidata Rave)
- Certified CRA (ACRP or SoCRA) preferred
- Exceptional leadership and stakeholder management skills