Job Description
Join BioPharm Innovations as a Clinical Research Manager and lead groundbreaking therapeutic development initiatives. You'll orchestrate end-to-end clinical trials while ensuring regulatory compliance and driving innovation in patient care. Our Cambridge headquarters offers cutting-edge labs and a collaborative environment where your expertise will directly impact global health outcomes.
Responsibilities
- Oversee Phase I-IV clinical trials from protocol design to final reporting
- Ensure strict adherence to FDA regulations, ICH-GCP, and ethical standards
- Manage relationships with CROs, investigators, and regulatory agencies
- Develop and maintain clinical trial budgets and resource allocation
- Analyze complex trial data and prepare regulatory submissions
- Mentor cross-functional teams including biostatisticians and data managers
- Implement risk-based monitoring strategies for trial optimization
Qualifications
- Master's degree in Pharmacy, Life Sciences, or Clinical Research (PhD preferred)
- 5+ years clinical trial management experience with 2+ years in leadership
- Proven track record in FDA/EMA submissions and compliance audits
- Advanced proficiency in CTMS (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of oncology or autoimmune therapeutics
- Certified Clinical Research Professional (CCRP) or equivalent
- Exceptional stakeholder management and problem-solving abilities