Job Description
Join Novartis Pharmaceuticals as a Senior Clinical Research Associate and drive innovation in life-changing therapies. Based in Cambridge's biotech hub, you'll lead pivotal clinical trials that transform patient outcomes. We offer a dynamic environment where scientific rigor meets cutting-edge technology, with opportunities to shape the future of medicine while working alongside industry leaders.
Our competitive compensation package includes comprehensive benefits, professional development stipends, and flexible work arrangements. If you're passionate about accelerating drug development and making a tangible impact in global healthcare, this is your opportunity to excel in one of the world's most respected pharmaceutical companies.
Responsibilities
- Execute clinical trial monitoring activities across multiple therapeutic areas ensuring protocol adherence and data integrity
- Lead site initiation, interim, and close-out visits with 100% compliance to GCP and ICH guidelines
- Manage electronic data capture systems and resolve data discrepancies within SLAs
- Collaborate with CROs, investigators, and internal teams to resolve critical study issues
- Contribute to risk-based monitoring strategies and vendor management oversight
- Prepare comprehensive monitoring reports and regulatory submissions for FDA/EMA compliance
- Mentor junior CRAs and optimize clinical trial processes through continuous improvement initiatives
Qualifications
- Bachelor's degree in life sciences, nursing, or related field; Master's or PhD preferred
- Minimum 5 years of clinical research experience with 2+ years in monitoring roles
- Certified Clinical Research Associate (CCRA) or equivalent certification required
- Proven expertise in oncology, immunology, or rare disease therapeutic areas
- Advanced proficiency in eClinical platforms (e.g., Veeva Vault RIM, Medidata Rave)
- Exceptional problem-solving skills and ability to navigate complex regulatory landscapes
- Strong cross-functional collaboration experience with biostatistics and data management teams
- Ability to travel 30-40% domestically and internationally as needed