Job Description
Join Novartis Pharmaceuticals at our Cambridge innovation hub, where groundbreaking therapies meet cutting-edge science. As a Senior Clinical Research Associate, you'll drive the execution of global clinical trials, ensuring adherence to GCP standards while accelerating life-changing treatments to patients. Collaborate with cross-functional teams in a dynamic environment that values scientific rigor and innovation.
Responsibilities
- Oversee site monitoring activities for Phase II-III clinical trials, ensuring protocol compliance and data integrity
- Lead investigator meetings and site initiation visits to establish trial feasibility
- Manage clinical documentation, including regulatory submissions and safety reports
- Coordinate cross-functional teams (biostatistics, medical, data management) to resolve trial issues
- Conduct risk-based monitoring and site quality assessments
- Develop and maintain strong relationships with investigative sites globally
- 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 (ACRP or SoCRA) required
- Deep knowledge of ICH-GCP, FDA regulations, and clinical trial methodologies
- Strong problem-solving skills with experience in risk-based monitoring
- Exceptional communication and stakeholder management abilities
- Proficiency in eClinical systems (e.g., Medidata Rave, Veeva Vault)
- Ability to travel up to 30% for site monitoring