Clinical Trial consultant

About Mira

We are Mira, a leading provider of assisted reproductive technology that helps couples and individuals who are having trouble getting pregnant. We started our company because we want to help women with their fertility journey, empower them with the best technology and information, and help them to reach their fertility goals.

We know that many women face fertility challenges when they try to start a family. The lack of awareness and information about our own fertility levels gives women tons of guesswork during their trying-to-conceive (TTC) journey. With a focus on personalized care and cutting-edge technology, we are committed to helping our customers achieve the highest possible success rates and the best possible outcomes.

About the position

We are looking for clinical trial consultant to work with our dynamic team on an ongoing clinical trial. The consultant will ensure that the trial design is feasible, effective and in accordance with the FDA guidelines for a 510k application.

Requirements

  • Masters or PhD Degree in life or medical sciences such as nursing or basic sciences. Advanced degree considered an asset.
  • A minimum of (5) years of experience with clinical trials
  • Experience with FDA submission of IVD OTC devices is required
  • Have led the creation of protocol, setting up, and managing a clinical trial
  • Have analyzed and troubleshot results of a clinical trial and applied improvements
  • Have led clinical trials involving participants at home-testing device
  • Must be an expert in lay user study design and lay user compliance in the design of a clinical trial
  • Prefer experience with clinical trials of OBGYN research
  • Assessing feasibility of study design in selected study settings and operational considerations that may require changes to study design
  • Have existing resources and connections to implement a study design (with feedback on budget)
  • Have conducted clinical trials within the company itself and with CRO
  • Designed a feasible and rigorous data collection and management plan

Details

This is consultant role, hourly paid.

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