Site Management Leader (SML)

About the role

We are seeking a Site Management Leader (SML) to oversee all site management and monitoring activities conducted by the CRO in a clinical trial. This role will be assigned to critical clinical trials of the Tango portfolio and serve as the primary contact between sponsor and CRO for site management aspects. In a fast-paced, small biotech environment, the SML will operationally oversee and manage the end-to-end site management activities as per approved timelines, budget, regulatory requirements, and internal standards. This individual will play a key role in the execution and delivery of clinical trial objectives. The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution. Your role Serve as the primary liaison between CTT and CRO for all site management activities Oversee CRO performance for site management to ensure compliance with contractual obligations, timelines, and quality standards Lead or contribute to the development of the Site Management Oversight Plan and other trial-specific operational plans in collaboration with CTT Contribute to the development of a site-related RBQM framework to drive efficiency and ensure quality of critical site management aspects Identify trial-level risks and contribute to the development and implementation of risk management and mitigation strategies Manage and monitor site identification, feasibility assessments, and site selection processes Ensure site readiness for initiation, including training, documentation, and logistical preparedness Oversee and support site initiation visits (SIVs) and ensure timely site activation Monitor patient recruitment strategies and enrollment progress across clinical sites Ensure protocol compliance and data integrity through oversight of site monitoring activities Review monitoring visit reports and ensure timely resolution of site issues and follow-up actions Collaborate with CRO to address site-level issues. Escalate unresolved issues to CTL and CTT, as needed Ensure adherence to ICH GCP, regulatory requirements, and internal SOPs throughout trial conduct Participate in audits, inspections, and quality assurance activities related to site management Oversee site closure activities and ensure proper documentation and archiving What You Bring 5+ years of trial management experience with 3+ years in site management. Leadership experience (preferred) Bachelor's degree in Life Sciences, Pharmacy or related field Experience working in global clinical development organization Experience in Oncology development (preferred) Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines Knowledge of trial/ site risk assessment and management Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred) Experience in outsourcing and oversight Familiarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIs Strong vendor management and project management skills Leadership skills with the ability to lead cross-functional teams Strong interpersonal and communication skills Strong analytical thinking and decision-making capabilities Willingness to travel, as required (typically 10 - 20%) We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #LI-Hybrid Salary range $128,000 - $192,000 USD