Director of Clinical Operations at Tidepool
Director of Clinical Operations
- Employees can work remotely
Tidepool is a 501(c)3 nonprofit organization on a mission to make diabetes data more accessible, actionable, and meaningful for people with diabetes, their care teams, and researchers. Founded in 2013, Tidepool hosts a suite of free software tools for people with diabetes and the clinics that serve them, including Tidepool Web, Tidepool Mobile, Tidepool Uploader, and, pending submission to FDA and associated review, Tidepool Loop. Learn more at tidepool.org.
Follow us on Twitter at @Tidepool_org and on Facebook and Instagram.
We are looking for a strategic Director of Clinical Operations, responsible for the management of all research studies. The Director of Clinical Operations develops, implements, and coordinates research and administrative procedures for the successful management of all current and future research studies and trials.
You will partner with Tidepool’s product, human factors, and engineering teams to contribute to the strategy of Tidepool products, and prioritize and manage research in a rapidly changing environment. You will partner with Tidepool’s human factors, quality, legal, regulatory team members, and medical advisors, to ensure our research processes meet the high standards required for a regulated medical device company. You will lead Tidepool’s efforts to implement and manage clinical studies, including traditional, multi-site studies as well as remote, decentralized studies.
Essential Duties and Responsibilities:
- In partnership with key team members, industry partners, and medical advisors, develop clinical research study protocols with strategic aims to test, validate, or collect data about Tidepool Loop or other Tidepool products
- Lead Tidepool’s efforts to implement virtual, decentralized clinical studies
- Administratively and clinically manage all clinical trials, including relations with contract research organizations and clinical sites
- Establish procedures to ensure adherence to protocols and administrative requirements
- Monitor trial progress to ensure compliance with and adherence to project plans and to identify, evaluate, and rectify problems
- Manage all trial budget(s)
- Act as the point of contact for each clinical study for all agencies (review boards, regulatory agencies, contract research organizations)
- Understand the requirements of the various controlling bodies, agencies, and frameworks, guiding projects in conforming to those requirements, and coordinating any necessary audit processes
- Coordinate the preparation and publication of data, reports, and information, ensuring that they meet legislative, contractual, and ethical requirements
- Ensure cross-functional alignment and consistency of clinical operations activities by collaborating closely with the internal team
- Work with any external agencies to ensure that trials meet their targets and produce meaningful output, and to predict and plan any changes that warrant requests to changes in protocol, funding, or time
- Plan and support all meetings and work of various groups, partners, bodies, and others, associated with any trials
- Assure that personal and confidential information is restricted to those entitled to know.
- Work with CEO, VP of Product and Business Development, medical advisors, and other team members to communicate all critical issues, business growth opportunities, key relationships, and provide input regarding organization budgeting discussions.
- Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with field teams on developing study protocols, driving site selection, and patient recruitment programs. Manage site training and monitoring, as needed.
- Contribute to a culture that shares research insight early and often. Participate in product discussions, design reviews, Human Factors reviews, and strategic research planning.
The ideal candidate:
- Experience executing clinical trials
- Skilled in a range of clinical study designs
- Excellent at presenting clear protocol design proposals and study goals
- Experience in study project management and prior management of contracted resources/CROs is required
- Passionate about improving clinical study processes to ensure that clinical study operations allow for conducting research quickly and impactfully
- Broad knowledge of all phases of clinical research, from study startup through closeout and primary publication and presentation
- Deep familiarity with research processes including protocol development, recruitment, site training, participant training, quantitative and qualitative research methods, data management including 21 CFR Part 11, regulatory submissions, and quality assurance monitoring
- Regularly reads, analyzes, and interprets information from professional journals, technical procedures, or governmental regulations… for fun!
- Knowledge of federal and state laws, regulations, policies, and procedures related to the protection of human subjects and confidentiality of research records
- Experience or direct practice with diabetes and diabetes technologies, (e.g., insulin pumps, continuous glucose monitor systems, data management systems) and clinical trials
- Experience in or interest in pioneering virtual clinical studies leveraging best in class mobile platforms, like iPhone’s ResearchKit or Verily’s Project Baseline
- International clinical trial experience and knowledge of outside of US regulatory requirements is preferred
- Experience with Human Factors studies is preferred
- Demonstration of consistent professional conduct and meticulous attention to detail
- Excellent verbal and written communication skills and well and excellent interpersonal skills
- Excellent organizational skills
- Proven high-level of attention to detail and ability to function independently and perform multiple critical tasks simultaneously under dynamic circumstances and competing deadlines
- Demonstrated ability to work collaboratively with a multidisciplinary team with a wide range of educational backgrounds
Salary and Benefits
- The salary range for the position is $131,200 to $205,400.
- Unlimited PTO
- Medical, Dental, and Vision coverage
- Flexible work schedule
- Wellness and Productivity stipend
- Continuing Education Reimbursement
- Other benefits
While many of Tidepool’s team members have a personal connection to diabetes, this is not a requirement. We do ask that you have empathy for chronic conditions and you are prepared to learn about the diabetes experience.
This is a remote position – you’ll be working from home and interacting with a team that works around the world, currently in 13 states and 5 countries. Learn more about working at Tidepool, including our approach to inclusion and diversity at Tidepool.org.
Does this sound like you? We’d love to hear from you!
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