Job Description
Join BioInnovate Therapeutics at the forefront of pharmaceutical innovation! We're seeking a visionary Senior Clinical Research Manager to lead groundbreaking clinical trials that transform patient outcomes. Based in our Cambridge, MA headquarters, you'll drive our mission to develop life-changing therapies while collaborating with world-class scientists and regulatory experts.
This role offers unparalleled opportunities to shape clinical development strategies, mentor emerging researchers, and contribute to therapies addressing unmet medical needs. Our cutting-edge facilities and collaborative environment provide the perfect platform for professional growth and scientific excellence.
Responsibilities
- Design and execute innovative clinical trial protocols ensuring compliance with FDA/ICH-GCP standards
- Lead cross-functional teams across CROs, medical affairs, and data management to ensure trial integrity
- Oversee site selection, monitoring, and management of global clinical trial operations
- Develop and manage clinical trial budgets, timelines, and resource allocation
- Prepare regulatory submissions and interact with health authorities (FDA, EMA)
- Mentor junior staff and implement continuous improvement initiatives
Qualifications
- Master's degree in life sciences, nursing, pharmacy, or related field (PhD preferred)
- Minimum 5 years clinical research experience with 2+ years in leadership
- Proven expertise in Phase II-III oncology or rare disease trials
- Strong knowledge of FDA regulations, EMA guidelines, and ICH-GCP
- Exceptional project management and stakeholder communication skills
- Certified Clinical Research Professional (CCRP) or equivalent required