Clinical Trial Manager

We’re looking for a Clinical Trial Manager who brings the operational rigor to keep complex studies on track, the interpersonal fluency to manage demanding partner relationships, and the personal investment in precision oncology that makes this kind of work more than a job.

Requirements

• 5+ years of clinical trial experience in the biopharmaceutical or diagnostic industry, or at an academic medical center
• 3+ years leading project operational teams through the full study lifecycle, start-up, conduct, data management, and report writing/review
• Experience working at or with a CRO, lab vendor, or biopharmaceutical company
• Solid working knowledge of Good Clinical Practices and all applicable U.S. regulations governing clinical research, with current GCP training documentation
• Working knowledge of the FDA submission process including IDE, PMA, and 510(k)
• International study experience and familiarity with GDPR implementation
• Experience managing complex clinical data sets, including genomic data
• A self-starting, ownership-oriented approach – you don’t wait to be told what needs attention
• Exceptional organizational skills and the ability to manage multiple concurrent priorities without dropping the details
• Outstanding verbal and written communication skills, including strong email responsiveness and a genuine customer-service orientation towards partners and sites
• Proficiency in Microsoft Office suite
• Bachelor’s degree or equivalent in a scientific field, or an equivalent combination of education, training, and experience

Benefits

• Medical, dental, and vision
• Flexible PTO and paid holidays
• Parental leave
• 401(k) with company match

Originally posted on Himalayas