Clinical Operations Manager

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.

WHAT YOU’LL DO

As a Clinical Operations Manager you will take part in areas of clinical trial management in North America as well as process improvements. This includes, but is not limited to, day-to-day activities such as trial start-up, conduct, and closeout activities on (multiple) clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies in collaboration with manager and others.  This is a remote position based in the United States.  Your responsibilities will include:

• Participate in the management of the completion of routine trial start-up, conduct, and close-out activities to industry and corporate standards, as requested.
• Evaluate and select investigative sites.
• Manage some aspects of trial operations including internal metrics, and communication of trial status within and outside the trial team.
• Initiate process improvement ideas for implementation.
• Participate in process improvement initiatives on a cross-functional level.
• Ensure that assigned clinical trial tasks are conducted in accordance with the protocol, country regulations, Good Clinical Practice regulations, and internal Standard Operating Procedures.
• Follow up and implement clinical site contracts and budgets.
• Support various tasks of the Study Team/Management with any trial-related activities in all phases of the conduct of the clinical trial.
• Prepare study-specific tools (including communication tools such as newsletters, flyers etc.).
• Manage study-related supplies to include Investigational Product.
• Assist with the writing and review of clinical documents such as informed consents, trial reports, and annual reports.
• Assist with the organization and participate in investigational meetings and site training representing assigned clinical trial.
• Perform co-monitoring visits as required.

WHAT YOU BRING TO THE TABLE

• 5+ years’ experience as Clinical Operations Manager, Project Manager and/or Senior CRA in Medical Device and/or Cardiology Trials 
• Broad knowledge of device clinical trial documentation including monitoring requirements, FDA/ISO14155, GCP and ICH regulations, and operational aspects of clinical trials
• Must be highly motivated, have excellent interpersonal and written communication skills, great desire to help others, composed under stress and well organized
• Strong critical thinking and problem-solving skills
• Clear and concise in verbal and written communication, foster smooth flow of timely and relevant information
• Ability to work well in a team environment but also independently on assigned tasks without significant oversight
• Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
• Excellent organizational and record-keeping skills
• Experience interfacing multiple vendors/contractors. 
• Ability to maintain excellent working relationships with a broad range of trial staff
• Detail and process oriented
• Positive attitude and approach
• Computer proficiency (MS Office - Word, Excel, Power Point and Internet skills), aptitude for training
• Must be willing and able to travel up to 15%
• Advanced computer literacy
• Self-starter 
• Experience in line management a plus

EDUCATION

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 cultures are celebrated.