Job Description
Join our cutting-edge pharmaceutical team at BioPharm Innovations Inc., where we pioneer breakthrough therapies to transform global healthcare. As a Senior Clinical Research Manager, you'll lead pivotal clinical trials from protocol design to FDA submission, ensuring compliance with ICH-GCP and regulatory standards. Collaborate with cross-functional teams to drive innovation in oncology and rare disease treatments, while mentoring junior researchers to uphold our commitment to scientific excellence. Enjoy competitive benefits including flexible work arrangements, comprehensive health coverage, and professional development opportunities in our state-of-the-art Parsippany facility.
Responsibilities
- Design and execute global clinical trial protocols for Phase II-III studies
- Lead cross-functional teams including CRAs, biostatisticians, and medical monitors
- Ensure regulatory compliance with FDA, EMA, and ICH-GCP guidelines
- Manage clinical trial budgets and vendor relationships
- Oversee data integrity and prepare regulatory submissions
- Mentor junior staff and implement process improvements
- Represent company at investigator meetings and conferences
Qualifications
- Master's degree in life sciences, pharmacy, or related field (PhD preferred)
- 8+ years clinical research experience with 3+ in leadership
- Proven track record in oncology/rare disease trials
- Certified Clinical Research Professional (CCRP) or equivalent
- Expertise in EDC systems (e.g., Medidata Rave) and CTMS
- Strong knowledge of FDA 21 CFR Part 11 and GCP
- Exceptional project management and stakeholder communication skills