Director Clinical Monitoring

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.  With our recent PMA approval from the FDA, we are preparing to grow our team – it’s a great time to join Endotronix!

WHAT YOU’LL DO

The Director Clinical Monitoring is responsible for managing a team of clinical researching monitoring professionals and clinical related activities on (multiple) clinical trials of moderate complexity and on large multi-center studies. You will:

• Manage and oversee the work of multiple clinical research associates, field monitoring scope and/or locations.
• Serve as a subject matter expert to provide monitoring guidance to leadership. 
• Develop a robust site monitoring talent development plan in alignment with functional growth strategies of the department.
• Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all project deliverables. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional teams.
• Lead on the strategic direction of field monitoring of studies and data collection for clinical trials (e.g., increased volume, upstream clinical projects) with increased volume and complexity (e.g., KOL site) , provide guidance to the Core Team, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.
• Act as a key stakeholder to drive and develop consistent monitoring practices, procedures (e.g., SOPs), and initiatives across Endotronix in partnership with cross functional teams.
• Identify and evaluate clinical process improvement opportunities
• Participate in development and validation of case report forms
• Review monitoring visit reports
• Lead team members to take appropriate actions on complex trial monitoring issues (e.g., CAPA) and review escalated monitoring visit reports.
• Identify risk, develop and lead in the implementation of broad and more complex monitoring strategies which may include negotiations with internal and external parties
• Lead technical guidance in the development of technical training on MDR/ ISO 14155 regulations, GCP and ICHs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements to as well as training and proctoring new employees on trial and study related activities to ensure alignment across Endotronix. Act as a mentor to new managers across the company.
• Make decisions on the output of clinical trial conduct improvements including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence and create proposal to leadership.
• Ability to interact effectively with senior management to individual contributor.

WHAT YOU BRING TO THE TABLE

• 5 to 10 years' experience in the device, biotechnical and/or pharmaceutical industry monitoring clinical trials. Device experience preferred, or trial management in a biotech/startup environment
• Experience in conducting clinical trials in cardiovascular therapeutic indications preferred
• Clinical research certification (ACRP or SoCRA clinical coordinator/ CRA certification) preferred
• Computer skills - Microsoft Office (Word, Excel, Access, PowerPoint), Internet
• 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
• Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines
• Successful track record of managing complex trials and site monitoring teams
• Familiarity with clinical research in Cardiology
• Must be highly organized and able to establish priorities
• Excellent organizational and record-keeping skills
• Outstanding interpersonal and community relations skills and the ability to communicate and work effectively within a diverse community
• Strategic planning skills
• Must be willing and able to travel

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

Endotronix is an equal opportunity employer.  We are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status or disability. Furthermore, we do not tolerate any form of discrimination or harassment of our employees by co-workers, supervisors, customers, or vendors.  This commitment extends to our policies on recruiting, advertising, hiring, placement, promotion, training, transfer, wages, benefits, termination and all other privileges, terms and conditions of employment.