Site Management Leader (SML)
$128k - $192kTango Therapeutics
Company OverviewTango 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.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 roleServe as the primary liaison between CTT and CRO for all site management activitiesOversee CRO performance for site management to ensure compliance with contractual obligations, timelines, and quality standardsLead or contribute to the development of the Site Management Oversight Plan and other trial-specific operational plans in collaboration with CTTContribute to the development of a site-related RBQM framework to drive efficiency and ensure quality of critical site management aspectsIdentify trial-level risks and contribute to the development and implementation of risk management and mitigation strategiesManage and monitor site identification, feasibility assessments, and site selection processesEnsure site readiness for initiation, including training, documentation, and logistical preparednessOversee and support site initiation visits (SIVs) and ensure timely site activationMonitor patient recruitment strategies and enrollment progress across clinical sitesEnsure protocol compliance and data integrity through oversight of site monitoring activitiesReview monitoring visit reports and ensure timely resolution of site issues and follow-up actionsCollaborate with CRO to address site-level issues. Escalate unresolved issues to CTL and CTT, as neededEnsure adherence to ICH GCP, regulatory requirements, and internal SOPs throughout trial conductParticipate in audits, inspections, and quality assurance activities related to site managementOversee site closure activities and ensure proper documentation and archivingWhat You Bring5+ years of trial management experience with 3+ years in site management. Leadership experience (preferred)Bachelor’s degree in Life Sciences, Pharmacy or related fieldExperience working in global clinical development organizationExperience in Oncology development (preferred)Knowledge of ICH-GCP, FDA guidelines, EU CTR and other relevant guidelinesKnowledge of trial/ site risk assessment and managementDirect experience with site health authority inspections (FDA, EMA, MHRA, etc.) incl. sponsor GCP inspections (preferred)Experience in outsourcing and oversightFamiliarity with clinical trial systems (e.g., CTMS, eTMF, EDC, IRT, eCOA) and operational metrics, KPIs, and KRIsStrong vendor management and project management skillsLeadership skills with the ability to lead cross-functional teamsStrong interpersonal and communication skillsStrong analytical thinking and decision-making capabilitiesWillingness 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-HybridSalary range $128,000—$192,000 USD
$100.05k - $156.49k
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