Site Management Leader (SML)

Tango Therapeutics•Boston, MA

18h•Hybrid

About The Position

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing. The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts. 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.

Requirements

5+ years of trial management experience with 3+ years in site management.
Bachelor’s degree in Life Sciences, Pharmacy or related field
Experience working in global clinical development organization
Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelines
Knowledge of trial/ site risk assessment and management
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%)

Nice To Haves

Leadership experience
Experience in Oncology development
Direct experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections

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