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Clinical Trials Manager

Roles & Responsibilities

  • 3+ years of project management experience in medical device and/or drug development clinical trials with a BS/BA in a relevant scientific discipline, or 1-2+ years of experience with an MS 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
  • Strong organizational skills, attention to detail, and ability to multitask

Requirements:

  • Develop, implement, manage and complete clinical trials operationally within designated programs and timelines
  • Lead development and communication of project updates/presentations to internal and external teams, including progress, timelines, and risks
  • Monitor day-to-day study activities, resolve issues, and generate high-quality trial documentation capturing activities and workflows
  • Collaborate with cross-functional internal teams and external stakeholders to manage, adjust, and revise project timelines and budgets; resolve issues per FDA regulations and GCP; manage external vendors as needed

Job description

Who We Are

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.

What You’ll Do

  • 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.

What You Bring

  • 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

We Want To Hear From You

At PathAI, we are looking for individuals who are team players, are willing to do the work no matter how big or small it may be, and who are passionate about everything they do. If this sounds like you, even if you may not match the job description to a tee, we encourage you to apply. You could be exactly what we're looking for. 

PathAI is an equal opportunity employer, dedicated to creating a workplace that is free of harassment and discrimination. We base our employment decisions on business needs, job requirements, and qualifications — that's all. We do not discriminate based on race, gender, religion, health, personal beliefs, age, family or parental status, or any other status. We don't tolerate any kind of discrimination or bias, and we are looking for teammates who feel the same way. 

The cash compensation outlined below includes base salary or hourly wage and on-target commission for employees in eligible roles. The summary below indicates if an employee in this position is eligible for annual bonus, overtime pay and equity awards. Individual compensation packages are tailored based on skills, experience, qualifications, and other job-related factors.

Annual Pay Range:
$69,750 - $106,950

Not Overtime Eligible
Eligible for Equity


#LI-Boston, MA or Remote

 

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