Job Description
Join BioInnovate Therapeutics, a leader in cutting-edge pharmaceutical research, as our Senior Clinical Research Manager. Based in Cambridge's vibrant biotech hub, you'll drive pivotal clinical trials that transform patient lives. We offer a collaborative environment where innovation meets impact, with competitive benefits and opportunities to shape the future of medicine.
Responsibilities
- Lead end-to-end clinical trial management from protocol design to FDA submission
- Oversee cross-functional teams including CRAs, data managers, and medical writers
- Ensure GCP/ICH compliance and regulatory documentation accuracy
- Analyze complex trial data and report key findings to stakeholders
- Develop innovative trial methodologies for accelerated drug development
- Collaborate with regulatory authorities on trial strategy and approvals
- Mentor junior research staff and drive process improvements
Qualifications
- PhD or PharmD in life sciences with 8+ years clinical research experience
- Proven track record managing Phase II-III oncology/neurology trials
- Certified Clinical Research Professional (CCRP) required
- Expertise in FDA/EMA regulatory pathways and submission processes
- Strong leadership skills managing global cross-functional teams
- Advanced proficiency in clinical trial management systems (e.g., Veeva RIM)
- Publiations in peer-reviewed pharmaceutical journals preferred