Clinical & Regulatory Ops Lead

Boston
Operations
Full Time
We’re Vital. We build products that combine cutting-edge science and intuitive design in ways that make measuring health and taking action accessible by everyone. Our mission is to democratize technology that puts people in control of their health.

This is a massive goal, and we're just getting started. We're looking for special people to join our team to help us make it a reality. At Vital, we thrive on change, operate on trust, and leverage diverse perspectives from the people on our team in everything we do. We operate at a rapid pace and we push key decisions to folks on the front lines across all of our teams. Our culture is fundamentally based on having a growth mindset - which means Vital is the kind of place where you can make an impact, somewhere you want to invest your talent and energy, and do your life’s best work. As a workplace, we challenge and support you to hone your craft and be a part of something bigger than any of us.

As the Clinical Operations lead, you will be responsible for the clinical execution of all studies across Vital's technology as well as managing all of our clinical relationships with KOLs and research collaborators.
You will build and manage the team responsible for overseeing the day-to-day clinical operations of Vital's portfolio of studies, ensuring they have the training, tools, and processes needed deliver high quality results.
You will also partner closely with our technical and operations teams to develop the training, processes, products, and enablement infrastructure to support our study coordinators in delivering consistent and high quality results.
This is a key operational leadership role for Vital. We’re looking for someone with the experience to set the vision for what this looks like, and the operational chops to build the teams, systems, and processes to make it happen.

You'll be working on things like:

    • Oversee the team responsible for the clinical execution of our validation studies, including recruitment, logistics, and resource management;
    • Develop and execute on strategies for scaling our operations, creating efficiencies, and delivering better internal SLA's for our validation function;
    • Own KPIs for clinical aspects of all studies, including metrics related to study startup timelines, data entry timeliness, and data quality;
    • Work closely with our Product, Engineering, and Data teams to develop new capabilities to increase efficiency and quality; you will be a primary stakeholder in roadmap development across our technical functions;
    • Partner cross-functionally to build the system for hiring, training, and enabling Vital's study coordinator team;
    • Oversee regulatory compliance across all studies;
    • Represent Vital externally to sponsors, partners, and regulatory authorities;
    • Constantly re-assess how we are executing clinical research, challenging assumptions and questioning the status quo;
    • Manage, provide accountability and serve as primary point of contact for operational project-specific issues and study deliverables;
    • Using cross-functional oversight of internal project team members and deliverables to ensure we're well resourced and project-specific training is provided.

You are:

    • Bringing 3 or more years of experience in life sciences or medical devices, including in a management role as a team lead or project manager, especially with experience leading a clinical operations team;
    • An experienced project manager. Simple or complex, you’re able to bring clarity and energy to a project, making everyone around you more effective;
    • A numbers person. You're comfortable with budgeting and managing costs with an focus on operational efficiency;
    • Comfortable with complexity. You aren’t intimidated by the complicated or difficult, and relish the opportunity to navigate a team through challenges;
    • Creative. You're ready to think of out-of-the-box ways to recruit patients and drive results for our team in validating our science;
    • Operationally-oriented. You can quickly break down a situation into the constituent parts, develop options, and execute on a plan. You naturally build machines to create operational efficiency, but don’t hesitate to tear them down when they aren’t doing their job;
    • A strong written and oral communicator. You know how to synthesize a complex situation into a few salient points, and are strategic in your external messaging;
    • Bonus points if you have PMP certification, have exposure to FDA processes, and Clinical Research experience.
Feel like you can’t tick all the boxes above? If you have some of the skills and experience that we’re looking for and are willing to use your talent to learn the rest, we encourage you to apply!