Senior Manager / Site Director, Clinical Operations

Job description

**Join Us in Shaping the Future of Clinical Research** Adams Clinical is a leading clinical trial site network committed to accelerating the development of life-changing medicines. Our mission is simple: deliver uncompromising data quality, safety, and diverse enrollment to advance healthcare. Our vision is to set the gold standard for clinical trial excellence. We believe our people make the difference. Guided by our core values—Scientific Rigor, Operational Excellence, Commitment to Sponsors and Participants, and Authentic Collaboration—we create an environment where meaningful work drives meaningful change. ***At Adams Clinical, you’ll find:*** - A culture of respect, transparency, and continuous improvement - Opportunities for professional growth and learning - A team dedicated to improving lives through innovation and integrity If you’re passionate about making an impact in clinical research and want to be part of a collaborative, mission-driven organization, we’d love to have you on our team. **Job Role** The Senior Manager provides site-level leadership and operational ownership of clinical operations, with direct responsibility for staff management, study execution, regulatory compliance, strategic alignment with network leadership, and ensuring high-quality trial execution that meets sponsor expectations and business objectives. The Site Director assumes the same core clinical operations responsibilities while providing broader site-wide leadership through additional support of the Clinical Science function, clinician development, cross-functional performance, and integration of clinical science with site operations in partnership with Clinical Science leadership. This is a highly people-focused leadership role requiring strong interpersonal skills, professional discretion and effective decision-making, and the ability to lead and develop employees at all levels of the organization. The ideal candidate is an approachable and accountable leader who builds strong relationships, communicates with clarity, and creates a culture of trust, collaboration, and high performance while maintaining clear expectations for site operations. **Key Responsibilities:** **Study Operations and Site Performance** - Serve as primary point of contact for day-to-day site issues; monitor study activities, enrollment, visit schedules, and site performance metrics for both inpatient and outpatient studies. - Support subject recruitment, eligibility assessments, randomization, and oversee study processes including ALCOA-compliant documentation, study trackers, investigational product handling, and ensure proper handling of participant safety events and adverse events (e.g., SAE/AESI reporting). - Identify operational, regulatory, or safety risks, implement mitigation strategies with senior leadership, and escalate critical issues. - Work closely with the Inpatient Unit Manager and the Associate Director of Inpatient Clinical Operations to support and oversee the conduct and quality of all inpatient studies at the site's inpatient facility. Ensure alignment on workflows, study execution, and safety practices within the inpatient unit. - Collaborate to bridge outpatient and inpatient operations, promoting continuity across study phases and ensuring consistent communication, documentation, and participant care standards between the two environments. - Collaborate with Finance to review Clinical Trial Agreement (CTA) invoicing, oversee participant reimbursement processes, and support site-level budget monitoring and forecasting to ensure financial compliance and operational efficiency. - Review monthly P&L and present to network senior leadership monthly on prior month performance. - Monitor screening outcomes and screen-failure trends related to operationally preventable factors to identify recurring issues and work with site study teams and Clinical Operations leadership to implement process improvements that improve overall screening quality. - Exercise appropriate autonomy in day-to-day site decisions while escalating matters that require network-level alignment, senior leadership input, or clinical or medical expertise. **Team Management and Development** - Foster a collaborative and accountable site culture by effectively navigating employee concerns, conflict, and performance issues; advocating for staff while balancing organizational expectations; and translating leadership priorities into clear, practical expectations for the team. - Lead, train, and develop the Clinical Research Coordinators (CRCs), Research Assistants (RAs), and Laboratory Technicians; assign responsibilities and track staff involvement across studies. - Work in close collaboration with and provide support to the principal investigators and medical sub-investigators. - Oversee and support the recruitment, hiring, and onboarding of key site personnel (PIs, clinicians, nurses, DSMs, CRCs, RAs) and conduct regular team huddles to review study progress. - Collaborate with leadership across departments and sites to coordinate resources, streamline processes, and drive operational excellence. - Work closely with the Associate Director and Vice President of Clinical Operations along with leaders of other departments and sites to coordinate resources, streamline processes, and drive operational excellence. This position reports directly to the Associate Director of Clinical Operations. **Facilities Oversight** - Oversee facility and building maintenance, including office services, safety inspections, drug room security, and pest control, while ensuring efficient use of site space and adequate workspaces for staff; collaborate with the Inpatient Unit Manager on inpatient facility needs. - Coordinate calibration of research equipment and support renovation, expansion, and relocation projects. - Manage local vendor contracts for study-related services, including laboratories and imaging. **Study Regulatory and Quality Oversight** - Represent the site at PSSVs, SIVs, and serve as an expert on site resources and SOPs. - Collaborate with regulatory teams to build and amend study source documents. - Monitor site activities for protocol and regulatory compliance, implement corrective actions, and support internal quality assurance checks. - Assist with DEA communications and audit response preparation. **Sponsor Relations and Study Communication** - Facilitate communication and collaboration between site teams, medical monitors, and senior leadership to address operational issues, share updates, and ensure alignment with study objectives. - Serve as a primary point of contact for sponsors, monitors, and other external stakeholders regarding operational and regulatory matters. - Generate and review site performance reports for leadership and sponsors. **Site Director: Broader Leadership Support** In addition to the responsibilities above, the Site Director provides broader leadership and operational ownership for the site, supporting alignment across clinical, operational, and study-related functions. This includes partnering with Clinical Science leadership and network clinical experts to promote effective training, assessment quality, therapeutic-area knowledge, appropriate staffing, and consistent study execution. - Support the coordination, development, and performance of clinician sub-investigators, including training needs, resource planning, and study staffing. - Collaborate with central clinical science leadership and participate in relevant Clinical Science meetings to support clinician development, coaching, quality, and consistency across the network. - Monitor clinical screening outcomes and screen-failure trends, identify recurring clinical factors or assessment findings contributing to screen failures, and work with clinicians and clinical leadership to improve assessment consistency, eligibility determination, and overall clinical screening quality.