Job Description
Join BioPharm Innovations, a leader in groundbreaking pharmaceutical research, as we pioneer the next generation of life-saving therapies. We seek a visionary Senior Clinical Research Manager to drive our clinical trial operations from protocol design to final submission. In this pivotal role, you'll lead cross-functional teams, ensure regulatory compliance, and accelerate drug development timelines while maintaining the highest ethical standards.
Our Cambridge headquarters sits in the heart of the world's premier biotech ecosystem, offering unparalleled collaboration opportunities with academic institutions and industry leaders. You'll work with cutting-edge technology and mentor talented researchers while contributing to therapies that impact millions of lives globally.
Responsibilities
- Lead end-to-end management of Phase II-III clinical trials across multiple therapeutic areas
- Oversee site selection, initiation, monitoring, and closure activities with global CROs
- Ensure strict adherence to FDA/EMA regulations, ICH-GCP, and protocol requirements
- Develop and manage clinical trial budgets, timelines, and risk mitigation strategies
- Collaborate with medical, regulatory, and data science teams to optimize trial design
- Prepare regulatory submissions and manage external stakeholder communications
- Mentor junior staff and implement continuous improvement in clinical operations
Qualifications
- PhD, PharmD, or Master's degree in life sciences with 8+ years clinical research experience
- Proven track record managing complex multi-center trials in oncology or rare diseases
- Deep expertise in FDA/EMA regulations, GCP, and clinical trial methodologies
- Advanced proficiency in CTMS, EDC systems (e.g., Veeva, Oracle), and eTMF platforms
- Strong leadership experience managing cross-functional teams and external vendors
- Certified Clinical Research Professional (CCRP) or equivalent preferred
- Exceptional problem-solving skills with ability to navigate regulatory challenges