Job Description

Your opportunity...
You will be an essential member of Kardium's senior management tasked with helping us to grow and develop into a leading, global medical device company. Our goal is to make a difference in the lives of millions around the world by delivering ground-breaking medical devices to treat the most common heart rhythm disorder, atrial fibrillation.
The Kardium team is smart, creative, and passionate. We work in a collaborative environment based on trust and respect, and we understand that only by working together can we solve the seemingly unsolvable.
In this role you will join Kardium as the Director of Clinical Operations responsible for designing and executing the clinical strategies for Kardium's products, including our upcoming IDE pivotal clinical study for the Globe Pulsed Field System.
Your responsibilities...

• Lead clinical strategy and clinical operations planning
• Build, develop, and provide leadership to the Clinical Operations team
• Work with internal and external subject matter experts, including key opinion leaders, to drive the design of clinical studies to support regulatory submissions, business objectives, and post-market surveillance
• Establish the clinical operations procedures and select the external vendors required to successfully complete clinical studies
• Ensure the timely completion and compliance of clinical trial activities, including:
• Budgeting and negotiation of contracts with investigational sites, investigators, and their clinical research staff
• Authoring and maintenance of required study documentation (trial master file, site study binders, study protocol, CRFs, informed consent forms, etc.)
• Recruitment and initiation of investigational centres
• Coordination of site monitoring, auditing and GCP compliance of investigational sites

You bring to Kardium...

• B.A./B.Sc. in a scientific area of study; M.Sc. preferred.
• 10+ years of clinical study experience, ranging from early feasibility to pivotal and post-market stages.
• Experience working with key opinion leaders to define clinical strategies.
• Thorough, working knowledge of clinical trial design, with a clear understanding of the intersection between study design, statistical design, regulatory strategy and intended use
• Proven ability to multitask, collaborate on cross-functional teams, work independently, and manage multiple time-sensitive high priority projects.
• Team leadership and people management.
• Excellent communication skills and working knowledge of English grammar, punctuation, and overall writing skills, with the ability to write clinical trial reports and documentation independently.
• Ability to develop or revise clinical trial procedures and processes, and working knowledge of clinical trial auditing.

What do you get out of this?
A meaningful career working with a truly innovative technology and an ambitious team, combined with:

• Knowing every day that you are making a difference in people's lives by helping treat a condition affecting millions of people worldwide
• A great working environment with opportunities to develop your skills and knowledge
• Opportunity to work with a multi-disciplinary team that includes engineers, software developers, biologists, clinical support, sales, manufacturing, supply chain, compliance, and regulatory affairs
• An engaged leadership team who believes in mentoring and growing employees' careers
• Supportive and fun colleagues with plenty of social events to encourage people connections
• And our employees think we are great too - check out Glassdoor to learn more!

How to apply...
If this position interests you, please send a resume and cover letter to jobs@kardium.com, with the job title "368 Director of Clinical Operations" in the subject line.Job Type: Full-time