Clinical Operations Lead (Manager or Director)

Boston, MA /
Clinical Affairs /
Full-time
At Cardiologs, our mission is to make tomorrow’s medical diagnosis efficient and accessible to everyone, anywhere, anytime. We leverage machine learning (AI) and cloud computing technologies to fulfill this vision. Our first product is a SaaS application to help physicians diagnose cardiac diseases, already deployed worldwide.

We are a small Boston-based team conveniently located off of the Charles/MGH Red Line station. We nurture our company culture with biweekly all-hands meetings and various office events that include lunch, dinner, and drinks. Most importantly, we believe that a good atmosphere at work makes people more efficient in what they are best at, so we hope you'll bring your own energy to our office.

What you’ll do

We are looking for a proactive and motivated Clinical Operations Lead (Manager or Director) who will be responsible for coordinating and supervising the execution of clinical investigations in the US.

Being the first Clinical Affairs team member based in our Boston office, you'll be the correspondent with the team based in Paris for matters related to US regulation activities with Regulatory Affairs/FDA in absence of the Clinical Dev Lead. You'll be the point of contact and manage collaboration and partnerships with contractors (e.G.CROs) and clinical partners to ensure the successful execution of clinical investigations.

Also, you will:
- Be responsible for coordinating and supervising the conduct of clinical studies in the US
- Plan and execute all operational aspects of clinical studies, and in accordance with the approved clinical strategy, project plans, budget and 
ressources.
- Facilitate and train investigation centers/healthcare professionals on the specificities of the clinical study in which they participate
- Monitor or supervise monitoring of clinical investigations
- Support development and maintenance of internal and external clinical study materials, processes, manuals, plans committees, etc (e.g. clinical study documents such as protocols, reports, clinical publications, etc)
- Ensure the control, collection, analysis, and validation of clinical data in collaboration with Cardiologs’ other teams (Data Science, Engineering, Product, RAQA, Marketing...)
- Develop and maintain the clinical quality system to ensure compliance with the applicable regulations.
- Manage the safety reporting in clinical investigations
- Support the Clinical Development Lead in developing the clinical strategy and ensuring its execution. 

Who you are

- An autonomous, enthusiastic, and reliable holder of a master's degree or Ph.D. in biomedical science, bioengineering, or similar.
- You have a minimum of 8 years of experience in clinical research.
- You already have clinical experience, as a Clinical Project Manager or a similar clinical research role, including extensive experience managing clinical investigations from planning to completion.
- You have solid experience in FDA studies.
- You already have experience in digital health
- Fluent in spoken and written English. French would be a plus.

Bonus:
+ An experience in decentralized clinical trials will be a plus.
Our Recruiting Process
Being authorised to work in the US is a precondition of employment.

- Quick introductory HR phone call
- Technical interview in our office or by Zoom
- Performance interview in our office or by Zoom
- Culture interview (with lunch or drinks with the team if possible!)
- Quick call with our CEO, Yann (only if you did not have the opportunity to meet him in one of the previous interviews)
- Reference calls