About the Company:
We are launching a mission-driven next-gen clinical trial enablement business that aims to bring life-saving treatments to more patients in need. Acting as a turnkey clinical trial enablement platform, this new venture will enable healthcare organizations to scale their clinical research capabilities with the goal of improving patient care, driving new avenues of revenue, enabling clinical trial enrollment, and increasing access to scientific advancements.
This stealth venture addresses the challenge of bringing clinical trial capabilities to Provider organizations, access to clinical trials to patients, and patient enrollment challenges for sponsors, with its comprehensive solution combining standardized processes and tools, skilled clinical research talent, and community-focused engagement to provide practitioners with a risk-free opportunity to unlock diverse patient populations, increase patient care options, and generate new revenue for their organization.
About the Job:
As Head of Clinical Trial Site Operations, you will be responsible for designing and implementing a program that creates efficient clinical trials at scale, drives enrollment, and increases access to scientific advancements. You will then be accountable for building out the resources and managing the operations required to ensure the successful execution of these clinical trials. You will work remotely and report to the CEO.
What you will do:
- Site Operations
- Develop, communicate, and enforce policies and standard operating procedures with an acute focus on quality.
- Responsible for overseeing all ongoing site identification operations, including growing site relationships, site engagement, site contracting, and end-to-end process optimization.
- Set and manage visit activity and key performance metrics to ensure goals are being met.
- Develop site budgets, targets, forecasting, and performance monitoring.
- Provide oversight of regulatory compliance for sites.
- Team Management
- Lead the hiring, managing, and scaling of the site team members, including clinical research coordinators.
- Drive the culture and performance of the team, instilling an ownership mindset in the trial operations.
- Take responsibility for the management and performance of the Site Identification team and have the opportunity to drive the team’s growth and strategic direction.
- Site Partnership and Selection
- Ensure that selected sites are meeting or exceeding all study startup, recruitment, retention, and data quality timelines.
- In partnership with the CEO and the Business Development team, build the strategy on the site selection process as the clinical trials site operational SME.
- Ensure sites we select to join our network are of the highest quality and align site growth targets to upcoming study opportunities in the pipeline.
- Executive Leadership
- Summarize data and insights in partnership with the CEO for business development and board materials, respectively.
- Present and communicate key business status updates to the board and investors.
What you will need:
- 10+ years of experience and progressive leadership responsibilities in clinical trial implementation and site operations roles, with a focus on quality.
- 5+ years of people management experience, demonstrating an understanding of how to motivate employees and build team culture.
- Experience in building and managing clinical teams in a rapid scaling environment, successfully taking a new site and establishing the correct processes.
- Experience in developing and implementing clinical processes and protocols.
- Demonstrated success in selecting, launching, and operationalizing new products, markets, projects, etc.
- Experience in launching and scaling clinical trial sites, starting from ground zero (0-1).
What you will bring to the table:
- Strong analytical and project management skills.
- A deep understanding of the complexity of clinical trials, with an acute focus on quality.
- Expertise in regulatory and compliance measures related to clinical trials.
- Familiarity with leveraging multiple technologies, including EMRs, CTMS systems, data, and analytics.
- Expertise in career pathing, recruiting, hiring, and onboarding of site staff.
Who you are:
- Optimizes Work Processes. You know the most effective and efficient processes to get things done, with a focus on continuous improvement.
- Strong Collaborator. You work cooperatively with others across the organization to achieve shared objectives, partnering with others to get work done and crediting others for their contributions and accomplishments.
- Manage Complexity. You ask the right questions to accurately analyze situations and uncover the root causes of difficult issues. By acquiring data from multiple and diverse sources, you are able to make sense of complex, high-quantity, and sometimes contradictory information to solve problems.
- Drives Results. You persist in accomplishing objectives and exceeding goals despite obstacles and setbacks, while also helping others to achieve results
- Builds Cohesive Teams. You recruit and retain talented individuals through the cultivation of a performance culture combined with inspirational leadership to support your teams.
You will work out of one of the following locations:
- Remote: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming
Additional Information
Full-time base salary of $162,000 to $198,000 plus equity.
Travel is required up to 25% when needed.
