Risk and Compliance Manager

Boston
Risk and Compliance
Full-time

Reify Health is seeking an individual experienced in risk and compliance issues in clinical research and technology to lead our R&C efforts. Reify Health builds technology that is being used by small and large clinical research sites as well as some of the largest pharmaceutical companies. Our small and growing team (~25) is driven to solve the hard problems which make clinical research expensive and prone to setbacks and failures. Success requires that we proactively create policies and procedures to guide the company in respecting and protecting the needs of its customers and, ultimately, the patients.

As Reify's Risk and Compliance Manager your job would be to interact with the founders to drive projects that deepen our stance and practice on R&C issues, prepare us to represent these stances to customers and partners, and to ensure that the team has a working understanding of how Reify Health handles these issues. Additionally, you would help in contract negotiation and administration of the policies you've written. An ideal candidate is experienced in regulatory concerns in clinical research, health IT, and data privacy on state, federal, and international scales and has specific experience with HIPAA, FDA, and IRB compliance policies.

About Reify

At Reify Health, we are building a more creative healthcare system. We envision a world where every potential therapy, if safe and effective, is available to the patients who can benefit.

Our healthcare system relies on clinical trials to develop new, potentially life-saving treatments for patients. But clinical trials continue to be slow, unpredictable, and expensive. Reify Health’s product helps both the research leaders driving forward clinical trials and the doctors and nurses who care for the patient participants. As we continue scaling the adoption of our product, we accelerate world class clinical research and unlock innovation. By joining our team, you would be a leader in a growing technology team, further establishing our foundation for a culture of impact and empathy.

Reify Health develops software to improve communication and coordination between sponsors of clinical research and clinical trial sites distributed across the US and the globe. Today our products focus on the pains of patient recruitment and enrollment, creating a better experience for patients and improving the ability for research sponsors to logistically manage clinical trials. This would reduce the risk and costs of individual clinical trials, enabling more research to be conducted and more therapies to be discovered for patients.

Reify has developed software in clinical research for 5 years and has large product and customer research resources arising from a partnership with a leading pharmaceutical company. We have identified a novel market opportunity with enormous upside and intend to use our initial product offerings to capture a large portion of this market over the next few years.

Outcomes and Goals

At Reify, you would be responsible for identifying, prioritizing, and executing our risk and compliance efforts. This role requires both the ability to solve risk and compliance problems creatively and the ability to think strategically about what efforts to make for maximal impact in a small team.

Take the helm in leading risk and compliance work at Reify Health in all of its interests. This is as much a leadership position as it is one of content expertise. An ideal candidate is confident solving clinical research technology compliance issues but also understands how to set priorities for this work against the business needs of a small company to get the biggest effect for the smallest effort. This role also involves overseeing risk and compliance work occurring at Reify Health's subsidiary company Care Access Research. You will collaborate with their compliance and contracts staff to coordinate policies throughout the company.

Review, improve, and evolve Reify Health's policies and procedures. This role involves working on the ground to identify holes and pain points with existing policies and procedures before executing changes to them to better protect the company's interests, represent the company's actual practices, and aid in the ease and confidence of staff working within these policies and procedures. An ideal candidate understands that P&P are living and need to respond to the actual work of a small, growing company while continuing to guide action away from risks.

Build, represent, and radiate Reify Health's stance on risk and compliance to our customers. Reify Health builds novel technology in a regulated space and therefore must be able to discuss with its customers the ways in which we interpret regulation and ensure the protection of our customers and ultimately the patients of clinical research. This role is responsible for creating and managing how we communicate our policies to our customers to build good relationships be it via proactively sharing how our contracts ensure mutual protection or by working through a customer's risk audit framework with experienced members of the team. An ideal candidate has experience interpreting policies and procedures externally and identifying needs from external partners which can be brought back in to improve our policies.

Be responsible for the operation and administration our policies and procedures. In order to continue to evolve Reify Health's policies we believe that this role should take responsibility for the administration of our policies and procedures. This ensures that blind spots and pain points are quickly identified and changes to the policies can be made with little overhead. An ideal candidate embraces this work and has experience fine tuning policy work to lower the burden on administration and all employees of the company.

Consult with sales, customer relations, product, and engineering to solve issues and answer questions. All aspects of Reify Health's business involve some discussion of compliance and policy issues and require some amount of expertise to arrive at the best answers. While crucial knowledge is shared among team members, often times we discover new questions or require canonical answers so that we can move forward effectively. This role is responsible for spending some time working with different functional areas of the company to identify compliance and risk questions and then to find and communicate their answers. An ideal candidate has this problem-solving mindset and is comfortable researching and working with outside experts to find the correct answers to novel questions encountered in this process.


RESPONSIBILITIES

    • Lead and operate a very small risk and compliance operation overseeing Reify Health's clinical trial technology work as well as how it fits into Care Access Research's clinical trial site operational work
    • Collaborate with founders to prioritize the most important risk and compliance work
    • Administrate current policies and procedures, change them to improve outcomes throughout the company
    • Collaborate with leads from various functional areas throughout the company to identify important risk and compliance projects and tackle them

REQUIREMENTS

    • Significant experience in compliance, contracts, risk management, and/or policy development in clinical research
    • Significant experience in compliance, contracts, risk management, and/or policy development in technologies in healthcare especially concerning data privacy and IT security
    • Familiarity with HIPAA, other FDA regulations, and IRB policies
    • Compliance certifications are a bonus (e.g. CRISC, CRMA, CHPC, CHPS, CHRC, and/or CCCP)
    • Proactive, problem-solving attitude and a desire to self-direct work to improve the company's position on compliance and risk
    • Familiarity with comprehensive risk analysis work involving physical, administrative, and technological components

COMPENSATION AND PERKS

    • Meaningful salary package -- commensurate to your experience and expertise.
    • Health (including telemedicine), dental, and vision. We pay 100% of your premiums and 50% for dependents.
    • Public transportation monthly pass. We are a short 2-3 minute walk from South Station.
    • Address complex, real-world problems in healthcare technology that directly help our friends and family -- and have large-scale impact.