WHO ARE WE?
Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs. The Company and our Clinical Operations team are growing, so it’s a great time to join.
WHAT YOU’LL DO
As the Project Manager of Clinical Operations you will implement and oversee all areas of clinical trial management. This includes, but is not limited to, managing day-to-day activities including trial start-up, conduct, and closeout activities on (multiple) clinical trials as well as management of Contract Research Organizations (CROs) and/or investigative sites. This is a remote position that can be based in Ireland, Germany or The Netherlands. Your responsibilities will include:
- Manage the completion of routine and advanced trial start-up, conduct, and closeout activities to industry and corporate standards
- Manage most aspects of trial operations including vendor performance, internal metrics, and communication of trial status within and outside the trial team
- Ensure that clinical trials are conducted in accordance with country's regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures.
- Consistently implement and successfully complete clinical research operations in clinical trials.
- Ensure the progress and completion of trial(s) in-line with trial goals
- Prepare and present trial specific updates to management.
- Assist with (or lead when necessary) the writing of clinical documents such as clinical protocols, informed consents, trial reports, and annual reports
- Plan and track trial timelines and budgets
- Report project progress and status to stakeholders proactively
- Interact effectively with senior management to individual contributors
- Perform miscellaneous job-related duties as assigned
WHAT YOU BRING TO THE TABLE
- 5+ years total experience in clinical research within a CRO or sponsor
- 2+ years' experience as a Clinical Project Manager in clinical device or pharmaceutical trials with a focus on cardiology
- Broad and deep knowledge of device clinical trial documentation including monitoring requirements, FDA/ ISO regulations, and operational aspects of clinical trials
- Strong initiative and positive attitude.
- Strong critical thinking and problem-solving skills
- Demonstrated ability to work independently
- High self-motivation and organization
- Results-driven and effective at working at all levels of the organization
- Experience interfacing and managing multiple vendors/contractors
- Clear and concise in verbal and written communication, foster smooth flow of timely and relevant information
- Ability to support and build collaborative relationships both internally and externally.
- Demonstrated ability to make timely decisions using sound judgment.
- Ability to efficiently organize and prioritize work within a multifaceted framework
- and set deadlines
- Excellent organizational and record-keeping skills
- Ability to work well in a team environment but also independently without significant oversight
- Flexibility in work hours and readiness to travel abroad on a routine basis
- Advanced computer literacy
EDUCATION
- Associate or bachelor’s degree preferred
WHO YOU ARE
- Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers
- Someone with a bias for action and quick iteration as opposed to perfection
- A quick learner, who is able to work independently, multitask, and drive your own projects
- An effective communicator and collaborator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights, models and tools that provide easily interpretable and actionable results
- A team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the parts
- Passionate about digital healthcare and leveraging Data to deliver innovative solutions at scale
WHAT WE’RE LIKE
- Willing to have the “direct and honest conversation”. Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
- Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results.
- Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
- Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.
- Entrepreneurial, flexible, yet results focused.
- High degree of intellectual curiosity, honesty, and capability.
- Low ego and humble in spirit in spite of your track record of outstanding performance.
LIFE AT ENDOTRONIX
- Our shared company values create a foundation of trust and collaboration. United in a common purpose, we excel at the task at hand to provide best-in-class medical technology and customer service to our patients and clinicians. And along the way we make sure to have a little fun, continue to grow and celebrate our successes.
- We provide a competitive compensation package, comprehensive benefits including unlimited PTO, and an environment that will help you to thrive and succeed in your career.
- Endotronix is an equal opportunity employer, and we are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, gender, marital status, citizenship status, age, veteran status, or disability. We are passionately committed to building a diverse organization where all perspectives and culture.