Job Description
Join NovoMed Therapeutics at the forefront of medical innovation as we pioneer breakthrough therapies in oncology and rare diseases. We're seeking a dynamic Senior Clinical Research Manager to lead pivotal trials across our global portfolio. This role offers unparalleled opportunities to shape clinical development strategies while collaborating with world-renowned scientists and regulatory experts. Our Cambridge headquarters features state-of-the-art labs and a collaborative culture that celebrates scientific rigor and patient-centric innovation.
Responsibilities
- Design and execute global clinical trial strategies from Phase I through Phase III
- Lead cross-functional teams including CROs, investigators, and regulatory affairs specialists
- Ensure protocol compliance with ICH-GCP and FDA/EMA regulations
- Oversee clinical site management, monitoring, and data quality assurance
- Develop risk-based monitoring plans and vendor management frameworks
- Represent clinical development in regulatory interactions and submissions
Qualifications
- PhD or PharmD with 8+ years clinical research experience in pharma/biotech
- Proven track record leading complex oncology/rare disease trials
- Expertise in risk-based monitoring and eClinical systems (Medidata Rave, Veeva)
- Strong FDA/EMA regulatory interaction experience
- Certified CRA (ACRP/SoCRA) preferred
- Exceptional project management and stakeholder communication skills