Manager of Clinical Operations
At Big Health, our purpose is to help millions back to good mental health. We do this by creating digital therapeutics: fully automated yet highly personalized programs that are scalable and clinically proven to work. Our programs harness the intimacy of the human voice and the power of animation to engage and entertain, while delivering complex concepts to help our users overcome their unique mental health challenges. Our Big Health mission is truly our guiding light. We want to help millions back to good mental health, and every interaction we have with a user is a chance to be impactful and help them to be one of those million.
We are looking for the first Clinical Operations hire at Big Health. As a result, you will be responsible for building a best-in-class Clinical Operations function to oversee the clinical and research activities associated with regulatory aims and compliance. This will begin with establishing the procedures and process of the function and will grow to hiring and managing a top notch team. You’ll report to the VP of Clinical Development & Medical Affairs and work closely with the VP of Quality and Regulatory to help us ensure the highest level of quality, compliance, and reporting for all clinical operations activities.
As the Manager of Clinical Operations at Big Health, you will:
- Develop Big Health’s Clinical Operations function, establishing a working model for how this function will support all clinical regulatory activities today, and how to grow the function over the next several years
- Support the achievement of regulatory compliance and clearance for our software-based medical devices
- Ensure cross-functional alignment and consistency of clinical operations activities by collaborating closely with the Clinical, Research, Quality, and Regulatory teams.
- Establish procedures and documentation to support Big Health sponsored clinical trials, clinical compliance activities, and clinical components of regulatory submissions (e.g., CSRs, CERs), and lead all related work streams.
- Assess and justify ROI of clinical research activities to ensure decisions regarding design and study prioritization are aligned with business needs
- 5-10+ years of clinical operations experience including prior experience managing the function
- Solid track record of supporting achievement of regulatory compliance and clearance for software-based medical devices, including familiarity with relevant medical device regulations and standards (e.g., 21 CFR 820, EU MDR, ISO 13485, ISO 14971)
- Independent Manager - You are comfortable working largely independently without extensive supervision, and are comfortable diving in and doing the work that needs to be done, in addition to managing others to support the work.
- Structured Problem Solver - You approach clinical operations decisions with structured problem solving to ensure you are recommending the solutions that optimize for the right factors for any particular situation.
- Organized and Process-Oriented - As a skilled project manager, you can balance a wide range of projects and tasks to your predetermined timelines.
- Detail-oriented and Polished - You understand details matter, particularly when it comes to regulatory procedures and documentation, and you ensure your work/your team’s work meets a high standard for accuracy and polish.
- Skilled Communicator - You are proficient at writing clear and accessible clinical procedures, summaries, and documentation as needed for clinical operations activities. You are an effective communicator with team members and external stakeholders, including leading efficient and productive meetings and managing team members.
Life at Big Health
- Be part of a team that includes clinical psychologists, software engineers, business leaders and even a former professional magician [shh… it’s a secret].
- Surround yourself with the smartest, most enthusiastic and dedicated people you’ll ever meet, but who listen well, learn from their mistakes and when things go wrong, generously pull together to help each other out
- Check out our values - they’re a living, breathing part of our culture
- Enjoy benefits including a generous vacation policy, professional development fund, flexible working locations and more.
- Competitive salary packages including stock options.
Because we are on a mission to bring millions back to good mental health, we believe it’s essential to reflect the diversity of those we intend to serve. We’re an equal opportunity employer dedicated to building a culturally and experientially diverse team that leads with empathy and respect. Additionally, we will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance