Senior Clinical Data Manager

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.Tango’s labs and offices are located at 201 Brookline Avenue, in the vibrant Fenway area of Boston, Massachusetts.SummaryThe Senior Manager, Clinical Data Management serves as the Data Management lead for assigned clinical trials and is responsible for the planning, oversight, execution, and delivery of data management activities from study startup through database lock and study closeout. The role provides sponsor oversight of outsourced data management activities, ensures high-quality and inspection-ready clinical data, and collaborates with cross-functional stakeholders to support trial execution, regulatory compliance, and clinical development objectives.Your Role:Serve as the Data Management representative within the Clinical Trial Team (CTT) and provide oversight of Data Management activities throughout the clinical trial lifecycleProvide sponsor oversight of CRO and external data vendors, ensuring Data Management, IRT and eCOA activities and deliverables are executed in accordance with study requirements, quality standards, timelines, budgets, contractual obligations, and regulatory requirementsEnsure timely delivery of complete, accurate, reliable, and inspection-ready clinical data through effective oversight of outsourced Data Management activities, including EDC, IRT and eCOA system build, validation and maintenance, data collection, data cleaning, medical coding, external data integration and reconciliation, database/system lock, and submission readinessReview and approve key Data Management deliverables, including CRF/eCRF, IRT, eCOA specifications, edit checks, Data Management Plans, CRF completion guidelines, data transfer specifications, external data reconciliation plans, and other study-specific documentationEstablish and monitor data quality metrics, KPIs, and data review strategies to ensure data integrity, consistency, and compliance throughout the study lifecycleLead oversight of external data integrations, transfers, reconciliations, and vendor-managed data streams to ensure completeness, quality, and regulatory compliancePartner with CTT, CRO and external vendors to support effective planning, integration, review, and reporting of clinical trial dataIdentify data-related risks and issues and lead the development, implementation, and monitoring of mitigation and contingency plansParticipate in audits, inspections, and inspection readiness activities and ensure timely assessment, response, and resolution of Data Management-related findingsContribute to regulatory submissions, health authority responses, and other regulatory deliverables, as requiredSupport the development and implementation of Data Management standards, processes, technologies, and continuous improvement initiativesWhat You Bring:Bachelor's degree in Computer Science, Life Sciences, Mathematics, Health Sciences, or related field5+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or CRO industryExperience leading Data Management activities for clinical trials in a regulated environmentExperience managing outsourced Data Management activities and providing vendor oversightExperience managing clinical systems (incl. IRT/ eCOA) configurations and implementations, enhancements, integrations, and technology vendors;Experience leading User Acceptance Testing (UAT)Experience supporting database build, data cleaning, external data integrations, medical coding, database lock, and submission readiness activitiesExperience working within global clinical development organizationsExperience supporting audits, inspections, and inspection-readiness activities preferredExperience using electronic data capture (EDC) platforms and clinical data technologiesOncology clinical development experience preferredStrong knowledge of Clinical Data Management processes and the clinical trial data lifecycleStrong knowledge of ICH-GCP, FDA regulations, EU Clinical Trial Regulation (CTR), data integrity principles, and other applicable regulatory requirementsKnowledge of CDISC standards, including CDASH and SDTM, and associated clinical data requirementsProficiency with EDC systems, IRT, eCOA, and related clinical technologiesKnowledge of medical coding dictionaries, including MedDRA and WHODrugFamiliarity with data visualization, analytics, and reporting toolsStrong understanding of risk-based quality management and critical-to-quality (CtQ) principlesStrong vendor management and sponsor oversight capabilitiesStrong project management, organizational, and prioritization skillsExcellent collaboration skills with cross-functional stakeholders, including Biostatistics, Statistical Programming, Pharmacovigilance, Clinical Operations, and Regulatory AffairsStrong analytical thinking, problem-solving, and decision-making capabilitiesExcellent written and verbal communication skills#LI-HybridWe 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.Salary range $144,800—$217,200 USD