Lightship is a clinical trial site organization delivering on-site, hybrid, and virtual trials through a single, trusted partner. Our Lightship is the virtual-first provider that is perfecting the way clinical trials get done. Because clinical research plays such a vital role in bringing life-enhancing and lifesaving innovations to market, Lightship pursues operational excellence to clinical studies. Our end-to-end hybrid delivery model, our diversity of skillsets, and inhouse care team ensure sponsor success and the best possible patient experience. With a problem-solving mindset, we strive to make every clinical trial better than the last. Operational excellence is not a goal, but a way of doing things at Lightship.
The SED leads investigator and site engagement across Lightship's network. Following investigator selection, the SED owns onboarding, credentialing, and site qualification, and maintains the investigator relationship throughout the site's tenure in the network. This individual is highly motivated and brings extensive site-facing experience in clinical research.
The SED maintains an accurate view of network capability and capacity, including site capabilities, therapeutic experience, staffing, and enrollment history, and supplies these inputs to feasibility, business development, and study teams. This role partners closely with the Chief Medical Advisor on investigator identification and clinical alignment, with Commercial on network strategy and sponsor opportunities, and with Operations at contract execution and through study start-up.
Given Lightship's distributed model and the remote nature of this position, this individual possesses a willingness and desire to work independently without significant oversight. In addition, this role will have travel up to 25%.
Site Engagement Director is responsible for:
Onboarding & Qualification
- Onboarding new investigators and sites once selected, delivering an onboarding experience that builds investigator confidence and long-term engagement
- Conducting and maintaining investigator credentialing, including license and credential verification, FDA debarment and exclusion checks, and research experience and study load review
- Assessing site infrastructure, staffing, and operational readiness on entry to the network and on an ongoing basis
Network Capability
- Maintaining Lightship's source of truth on network capability and capacity, including site capabilities, therapeutic experience, staffing, equipment, and enrollment history
- Supplying accurate site-level capability, capacity, and enrollment inputs to feasibility and business development
- Supporting the expansion and readiness of Lightship's investigator network in partnership with the Chief Medical Advisor and Commercial
Investigator Relationships
- Owning the investigator and site relationship for the life of the site, serving as the primary point of continuity across studies and sponsors
- Establishing and sustaining investigator communication and meeting cadence across the network, ensuring investigators are heard, informed, and responded to
- Serving as the escalation point for relationship, network, and site-level issues that fall outside the scope of an active study
- Driving investigator retention and satisfaction, capturing feedback and converting it into operational improvement
- Delivering investigator education and corporate training that keeps the network current on Lightship's model and capabilities
Study Handoff & Support
- Executing the handoff to Operations at contract execution, ensuring the Project Manager and study team inherit a fully onboarded, ready site without breaking the investigator relationship
- Setting investigator expectations at study start-up and establishing site communication cadence before activation, in partnership with the study team
- Supporting sites through the first 30 days post-activation, in partnership with the Project Manager
Metrics & Reporting
- Owning site engagement metrics and reporting, providing leadership with visibility into network health, onboarding throughput, and investigator satisfaction
- Identifying risks to investigator engagement and network readiness, and implementing mitigation proactively
Team Leadership
- Leading, developing, and mentoring Site Engagement team members
- Supporting hiring, onboarding, and training as the function grows
Site Engagement Director has:
- Required knowledge, skills, and abilities
- Demonstrated ability to build and sustain trust-based relationships with investigators and site staff over multiple years and multiple studies
- Strong working knowledge of clinical trial site operations, investigator qualification, and site readiness
- Ability to hold and communicate an accurate picture of network capability, and to say no when a site is not a fit
- Comfort operating at the boundary between Commercial, Medical, and Operations without owning any of their work
- Ability to adapt to a fast-paced start-up environment
- Critical thinking and problem-solving abilities
- Strong verbal and written communication skills; strong presentation skills
- Proficiency in clinical systems and reporting tools
- 5-10 years of clinical research experience, with meaningful time spent site-facing or investigator-facing
- Experience in site engagement, site management, or site relationship ownership across a network of sites
- Experience supporting feasibility or business development preferred
- Prior leadership or people management experience preferred
- Bachelor's Degree, required; advanced degree in healthcare-related field, preferred; or requisite combination of education, training, and experience
Success measures:
- Investigator onboarding cycle time, from selection to greenlight to join studies
- Accuracy of network capability and capacity data, and how current it is kept
- Accuracy of site-level inputs supplied to feasibility, measured against actual enrollment performance
- Investigator retention and satisfaction across the network
- Coverage of active engagement cadence across the network
- Growth and readiness of the investigator network in Lightship's priority therapeutic areas
