Summary 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%)
#LI-Hybrid
Salary range
$128,000-$192,000 USD
