Site Management Leader (SML)

Site Management Leader (SML)

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.

Responsibilities

• 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

Requirements

• 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%)