Job Description
Join BioPharm Innovations LLC, a leader in cutting-edge pharmaceutical research, as we pioneer next-generation therapies. We seek a dynamic Senior Clinical Research Manager to oversee complex clinical trials and drive regulatory compliance excellence. This role offers unparalleled opportunities to shape drug development pipelines while collaborating with top-tier scientists and global regulatory bodies. Enjoy competitive benefits, professional development stipends, and a culture that celebrates innovation and patient-centric solutions.
Responsibilities
- Lead end-to-end management of Phase II-III clinical trials, ensuring protocol adherence and data integrity
- Oversee cross-functional teams of CRAs, biostatisticians, and medical monitors
- Ensure compliance with FDA/ICH-GCP regulations and internal SOPs
- Develop trial budgets, timelines, and risk mitigation strategies
- Present clinical data to regulatory authorities and ethics committees
- Mentor junior staff and implement process optimization initiatives
Qualifications
- MS/PhD in Life Sciences or related field with 8+ years clinical research experience
- Proven track record managing multi-center oncology trials
- Certified Clinical Research Professional (CCRP) or equivalent
- Expertise in EDC systems (e.g., Medidata Rave) and CTMS platforms
- Strong regulatory affairs background with FDA interaction experience
- Exceptional leadership and stakeholder communication skills