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Clinical Trial Manager

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Experience: 
Mid-level (2-5 years)
Work from: 
Massachusetts (USA), United States

Offer summary

Qualifications:

3+ years of project management experience in medical device and/or drug development clinical trials, BS or BA in a relevant scientific discipline, or 1-2+ years with M.S. or PhD, Robust understanding of clinical trial regulations, GCP and GCLP, Experience in digital pathology or imaging preferred.

Key responsabilities:

  • Manage and complete clinical trials within programs and timelines
  • Develop presentations and keep teams updated on progress, risks, and timelines
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PathAI Scaleup http://www.pathai.com/
501 - 1000 Employees
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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. You will participate in clinical trials of novel drugs designed to improve the quality of life for people suffering with various diseases.

Where You Fit

We are looking for 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.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Social Skills
  • Detail Oriented
  • Multitasking

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