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.

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.
Experience in digital pathology, radiology or other imaging technology-based clinical trials is highly preferred.
Good organizational skills, attentive to details, and able to multitask.
Project Management Certification is a plus.
Strong understanding of laboratory practices, histology, and pathology preferred.
Experience in MASH, IBD, and Oncology preferred

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

project managementclinical trialstrial documentationdigital pathologyradiologyimaging technologylaboratory practiceshistologypathologyGCP

Soft Skills

interpersonal skillsteam collaborationorganizational skillsattention to detailmultitaskingproblem-solvingcommunicationprioritization

Certifications

Project Management Certification