Manager/Senior Manager, Clinical Research

At Eko, we’re dedicated to providing healthcare professionals with industry leading digital tools to hear and understand their patients’ hearts and lungs. With our platform, clinicians can detect cardiopulmonary disease with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible.  
With over $125M in funding from partners like 3M and the Mayo Clinic, Eko has become one of the fastest growing digital health companies, doubling our customer base in the last year to over 135,000 clinicians across 4,000 U.S. hospitals. We’ve built a tremendously talented, diverse, and mission driven team and are proud to be certified as a Great Place to Work®. Together we are committed to investing in each other and our mission to ensure all patients have access to high quality care.
The Manager/Sr Manager of Clinical Research must be a fearless leader who has experience with setting up and managing multiple clinical studies, is able to work independently with clinical partners to drive study execution and ensure data needs are being met, and is experienced with organization-level strategy. The ideal candidate has familiarity with and/or a deep passion for health technology. This role reports directly to the VP of Clinical.

As the Manager/Senior Manager, Clinical Research at Eko You Will:

• Work alongside the VP of Clinical and Director of Clinical R&D to plan out real world evidence strategy and execution, including problem-solving how to efficiently and effectively meet data needs of outcomes development across different forms of data collection.
• Own real world evidence study roadmap and drive cross-functional collaboration to ensure studies are meeting the data needs for claims and other development goals. Implement end-to-end action based on company priorities
• Generate risk-mitigation plans proactively and socialize early; independently and efficiently identify, manage, and solve issues as they arise
• Drive setup of new studies, including IRB submission activities with study site(s), development of case report forms and operations manuals, development and setup of data management plans, and study device setup
• Independently create, negotiate, and manage project budgets and implement cost effective solutions; perform initial review of study invoices
• Assist in subject recruitment and enrollment strategies
• Train new study sites to the operations manual and study protocol
• Ensure that study sites are able to meet data quality needs, protocol requirements, and timelines/milestones
• Serve as the primary liaison with ongoing research sites; monitor the day-to-day conduct of the study, track progress, and proactively resolve problems and obstacles
• Independently and proactively track study status and maintain study documentation; provide preliminary review of incoming study data for quality and completeness
• Report and present study status and schedules to senior management

As Manager/Senior Manager, Clinical Research, You Have:

• Bachelor’s degree in the Sciences, or equivalent, and 6+ years of experience as a Clinical Research Associate or Clinical Research Coordinator, or equivalent
• Strong understanding of clinical research techniques and principles (HIPAA, ICH-GCP); experience with designing and managing studies in a regulated environment
• Impeccable organizational skills with meticulous attention to detail and a tendency to think 10 steps ahead
• Standout verbal and written communication skills
• Natural problem-solver, autonomous self-starter, and a “roll up your sleeves” work style
• Proven problem-solving and analytical skills, ability to handle ambiguity, and good business judgment
• Strong understanding of the use of real-world evidence in clinical trials
• Experience conducting exploratory data analysis and presenting complex data into an easy-to-inpret manner
• Independently able to write clinical study protocols, consent forms, case report forms, and other study materials for IRB submission
• Experience with managing ongoing, multisite clinical studies to ensure data quality is being maintained, enrollment targets are being met, and any issues are triaged and resolved while minimizing impact to data collection
• Able to rapidly acquire familiarity with emergent technologies and software algorithms

As Manager/Senior Manager, Clinical Research, We Would Appreciate if You Have:

• Experience working in health technology space, familiarity with algorithm development process
• Working knowledge of cardiovascular, pulmonary, and vascular diseases
• Experience with basic statistical analysis of real-world data
• Experience supporting a variety of study designs spanning clinical trials and observational research desi