Clinical Trial Manager

Your opportunity
By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation - which can cause stroke, heart failure, and other heart-related complications.
Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System - we have a fantastic technical team that has developed a product with strong, unique, and customer-valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.
We have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
As a member of the Clinical Operations team, the Clinical Trial Manager role is responsible for supporting clinical trial initiation and management to support oversight of clinical trials at Kardium as we head forward into the commercial and development landscape. Reporting to the Director of Clinical Operations, you will work closely with other members of our clinical operations team and vendor teams to ensure clinical trials run at Kardium are conducted with the highest quality and efficiency. This role is also a growth opportunity for team leadership in the future.
Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.
Meaningful work you will be a part of
**Your responsibilities will include**:

- Overseeing all phases of clinical evaluation research studies. This may include studies at various stages and phases of a clinical product life cycle.
- Preparing and providing operational input to clinical study protocols and trial designs.
- Work collaboratively with cross-functional teams to identify and set up clinical sites for clinical trial protocols.
- Developing and overseeing clinical study site communications to support efficient and quality implementation of clinical trial activities.
- Supporting and overseeing the development and implementation of study plans and procedures.
- Conducting ongoing reviews of project goals and deadlines required for data collection.
- Overseeing site monitoring and reviewing Interim Monitoring Visit (IMV) reports.
- Coordinating with the data management team for data collection and analysis.
- Overseeing and resolving operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations, and may prepare clinical trial budgets
- Reporting trial progress to members of the leadership team.
- May be responsible for clinical supply operations, site and vendor selection.
- May be responsible for vendor oversight throughout a clinical trial.

What you bring to the team
Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable.
You will be successful in this role because you possess these attributes:
Education & Experience
- Master’s degree or equivalent experience in life sciences, nursing or related field.
- 8+ years overseeing the implementation of clinical trials (e.g. CRO, Sponsor etc.).
- Proven experience as a Clinical Trials Manager or similar role.
- Prior experience managing industry-level trials is an asset.
- Experience working in Medical Device trials, cardiology experience is an asset.

Requirements & Skills
- Extensive knowledge of GCP guidelines, ISO, FDA and ICH regulations.
- Excellent leadership and team management skills.
- Experience with a variety of electronic data capture (EDC) systems.
- Experience and expertise in Trial Master File (TMF) Management and budget management.
- Excellent project management and leadership skills.
- Ability to problem-solve and make decisions under pressure.
- Strong communication and interpersonal skills.
- Proficient in Microsoft Office Suite.
- Ability to travel as needed.

Compensation
As a permanent employee, you will also participate in Kardium’s stock option plan.
- $100,000-130,000 (CAD Annually)

Your Benefits & Well-being
The total cash we’ve listed for this position includes a base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals.
Comprehensive medical & dental coverage for all permanent employees - effective as of Day 1, with no waiting period.
Work-day flexibility - additionally, we provide 3 personal days per year.
Support for you (and your dependents) overall well-being.
Family building - we provid