Job Description
Join BioNova Therapeutics at the forefront of pharmaceutical innovation as we develop groundbreaking treatments for rare diseases. As a Senior Clinical Research Manager, you'll lead cross-functional teams through complex clinical trials, ensuring regulatory compliance and data integrity. Our Cambridge-based hub offers cutting-edge labs and collaborative spaces where science meets purpose. If you're passionate about accelerating therapies from bench to bedside, this role is your opportunity to shape the future of medicine.
Responsibilities
- Design and execute Phase I-III clinical trials with GCP compliance
- Lead cross-functional teams including CROs, investigators, and regulatory affairs
- Manage trial budgets exceeding $5M and vendor relationships
- Develop risk-based monitoring strategies and ensure protocol adherence
- Submit regulatory documents (IND/IMPD) and interact with FDA/EMA
- Analyze clinical data and prepare safety reports for stakeholders
Qualifications
- MS/PhD in Life Sciences or Pharmacy with 8+ years clinical trial experience
- Certified CRA (ACRP) or Project Management Professional (PMP)
- Proven track record leading oncology or rare disease trials
- Expertise in EDC systems (Medidata Rave, Veeva Vault)
- Strong FDA/EMA regulatory interaction experience
- Exceptional leadership and cross-functional collaboration skills