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Clinical Research Manager

Chicago, IL
Customer Success

Description

PatientIQ is a fast-growing health tech company empowering healthcare providers, industry, and researchers to collaborate on the mission to improve patient outcomes. PatientIQ is headquartered in Chicago and backed by top-tier west coast venture capital, major hospital investors, and others.

About the Role

PatientIQ is seeking an experienced Clinical Research Manager to support and grow our customer base of academic medical centers and medical device companies utilizing the PatientIQ Real-World Evidence platform. As a Clinical Research Manager at PatientIQ you will be primarily responsible for supporting and expanding our ecosystem of clinical research clients who use the PatientIQ software platform for Prospective Studies, Retrospective Studies, Randomized Controlled Trials, Registries, and Multicenter Studies.

To be successful in this role, you will need to have a solid foundational understanding of clinical research, the institutional review board approval process, and other associated regulations and best practices. You will be responsible for developing and maintaining relationships with key stakeholders, including study sponsors, regulatory agencies, and principal investigators. Additionally, you will come from a background where you have developed experience with more than one of the following:

  1. FDA 510(k) premarket submission process
  2. FDA 522 post-market surveillance studies
  3. Investigational Device Exemptions (IDEs)
  4. Investigator-initiated research at an academic hospital
  5. Another type of regulated clinical research

Requirements

  • 8+ years experience in clinical research with an understanding of clinical trials methodology and terminology
  • Bachelor or equivalent degree in biological science, pharmacy, or other health-related disciplines
  • Hold a Clinical Research Certification such as a SOCRA or ACRP
  • Expert knowledge of FDA regulations and Good Clinical Practice (GCP) Guidelines.
  • Experience in client-facing roles, including the ability to communicate effectively with medical device executives, medical affairs, and principal investigators
  • Understanding of core study regulatory documents, including drafting study protocols, budgets, and informed consent forms
  • Familiarity with statistical analysis and Electronic Data Capture (EDC) software
  • Strong interpersonal, written, and verbal communication skills within a multidisciplinary team
  • Experience working in a self-driven capacity, with a sense of urgency and limited oversight

Benefits

WHY WORK HERE?

  • Great Benefits - top-notch health, dental and vision insurance. Additional perks available including 401K.
  • We are Mission Driven - our team is motivated to solve complex problems, drive medicine forward, and ultimately improve patient outcomes.
  • True Idea Meritocracy - great ideas win out. We encourage all team members to challenge the status quo because our mission demands this.
  • Flexible Time Off - we trust you to take the time you need when you feel it is appropriate, given your workload and responsibilities. No need to track it or save up.
  • World-Class Team - we’re at the top of our industry because of our employees. They’re the best investment we can make, and we never forget that.
  • Fast Growing - we are building the largest platform for healthcare providers, industry partners, researchers, and others to collaborate on the mission to improve patient outcomes.