Job Description
Join BioPharm Innovations, a leader in groundbreaking pharmaceutical research, as we pioneer the next generation of therapeutics. We're seeking a Clinical Research Manager to oversee pivotal Phase II-III trials in our state-of-the-art Cambridge facility. This role offers the opportunity to lead cross-functional teams, ensure GCP compliance, and directly impact patient outcomes through innovative drug development. Our collaborative environment fosters professional growth with competitive benefits and cutting-edge resources.
Responsibilities
- Design and execute complex clinical trial protocols across multiple therapeutic areas
- Lead cross-functional teams including CRAs, data managers, and medical monitors
- Ensure regulatory compliance with FDA/ICH-GCP guidelines and company SOPs
- Manage clinical trial budgets and vendor relationships
- Analyze and interpret clinical data to support regulatory submissions
- Mentor junior staff and foster a culture of scientific excellence
- Present trial progress to executive stakeholders and ethics committees
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years clinical research management in pharmaceutical/biotech
- Proven experience with Phase II-III trial execution in therapeutic areas
- Advanced knowledge of FDA/ICH-GCP and global regulatory requirements
- Certified Clinical Research Professional (CCRP) or equivalent
- Strong leadership and cross-functional collaboration skills
- Proficiency in eCRF systems and clinical trial management software
- Exceptional problem-solving and risk management abilities