Clinical Trials Manager
About The Position
PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you'll work with a diverse and talented team of people, who are dedicated to solving complex problems and making a huge impact. Where You Fit PathAI is seeking a dynamic clinical project manager who will report to the Head of Clinical Operations to drive our clinical study roadmaps by partnering with internal and external stakeholders. Scientific and project management skills will be key to success in driving the necessary studies for pre- and post-market assessment of our products, as well as clinical trial services.
Requirements
- 3+ years of project management experience in medical device and/or drug development clinical trials and a BS or BA in a relevant scientific discipline, or 1-2+ years of experience with an M.S. or PhD in a relevant scientific discipline.
- Robust understanding of clinical trial regulations, GCP and GCLP.
- Good organizational skills, attentive to details, and able to multitask.
Nice To Haves
- Experience in digital pathology, radiology or other imaging technology-based clinical trials is highly preferred.
- Project Management Certification is a plus.
- Strong understanding of laboratory practices, histology, and pathology preferred.
- Experience in MASH, IBD, and Oncology preferred
Responsibilities
- Responsible for, and must have a demonstrated ability to successfully develop, implement, manage, and complete clinical trials operationally within designated programs and timelines.
- Lead development and communication of presentations to keep internal and external teams aware of progress, timelines, and risks, ensuring successful completion of projects.
- Generate high quality trial documentation, properly capturing trial activities and workflows, with high attention to detail.
- Manage day to day monitoring of study activities and any issues that may arise.
- Partner with cross functional internal teams (Engineering, Clinical Science, BioPharma Laboratory, etc.) and external stakeholders to manage, adjust, and revise project timelines/budgets as necessary.
- Must be able to resolve problems using FDA and other regulations, adherence to GCP requirements, and through regular site interactions.
- Demonstrate excellent interpersonal skills, ability to bring teams together to successfully plan and execute PathAI clinical trials, and ability to prioritize with multiple competing priorities.
- Manage external vendors, as needed.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
101-250 employees
