Remote Senior Director, Clinical Data Management

Note: The job is a remote job and is open to candidates in USA. Umoja Biopharma is an industry-leading biotech focused on transforming the treatment of cancer with a novel integrated immunotherapy platform. The Senior Director, Clinical Data Management will provide strategic and operational leadership for all clinical data management activities across Umojas clinical development programs, ensuring data integrity, quality, and regulatory compliance.ResponsibilitiesServe as the primary clinical data management lead for assigned clinical trials, with direct accountability for data quality, timeliness, and inspection readiness from protocol development through database lockPerform detailed protocol review with a focus on data flow, endpoints, data collection strategy, and facilitation of downstream analysis requirementsLead hands-on CRF design and review, ensuring alignment with protocol objectives, statistical analysis plans, and regulatory expectationsDevelop, review, and approve data management plans (DMPs), database specifications, edit check specifications, data transfer agreements, and data review plansActively participate in EDC system configuration and validation activities, including review of database builds, user acceptance testing (UAT), and system change controlPerform ongoing hands-on data review, query trend analysis, and proactive data cleaning to ensure high-quality, analysis ready datasetsPartner with Clinical Operations and other groups to define and implement data quality standards, reconciliation strategies, and risk basedmonitoring approaches for clinical dataLead hands-onoversight of external CROs and vendors delivering data management services, including detailed review of deliverables, issue resolution, and escalation managementDirectly review and contribute to data listings, data exports, and interim analysis datasets in partnership with Biostatistics and Statistical ProgrammingEnsure clinical trial data is compliant with applicable regulatory requirements, including GCP, ICH, and CDISC standardsSupport inspection readiness activities by authoring, reviewing, and maintaining data management documentation and responding directly to audit and inspection findingsPartner closely with Clinical Operations to align data management activities with study execution, site operations, monitoring strategies, and operational reporting needsCollaborate with Biostatistics and Statistical Programming to ensure smooth handoff of clean, well documented- datasets for analysis and reportingProvide technical data management expertise to Regulatory Affairs in support of clinical study reports, INDs, BLAs, and other regulatory submissionsServe as the clinical data management subject matter expert on study teams, governance forums, and internal reviewsOwn and continuously improve clinical data management processes, tools, and SOPs to support efficient execution in a growing organizationEvaluate, implement, and optimize clinical data systems and technologies (e.g., EDC, IRT, eCOA) to enhance data quality, traceability, and scalabilityContribute handson to vendor selection, scope definition, and budgeting for data management services and systemsSkillsBachelor's degree or higher in life sciences, health informatics, computer science, or a related discipline with a minimum of 15 years of experience. Equivalent combinations of education and experience will be consideredSignificant experience in clinical data management within the biotechnology or pharmaceutical industry, including 8+ years of leadership of data management functions for clinical trialsDemonstrated experience overseeing CROs and external vendors delivering clinical data management servicesStrong working knowledge of clinical trial processes, EDC systems, data standards, and regulatory expectations for clinical dataProven ability to lead teams, manage complex programs, and collaborate effectively in a fastpaced, matrixed environmentExcellent written and verbal communication skillsExperience supporting oncology and/or cell or gene therapy clinical development programsExperience building or scaling clinical data management capabilities in a growing biotech organizationPrior involvement in regulatory submissions and inspection readiness activitiesBenefitsCompetitive Medical, Dental, and Vision plans401k plan through Fidelity, with a 100% match up to their first 4% deferralGenerous Paid Time Off policyEmployee commuter benefitsCell phone stipendCompany OverviewUmoja Biopharma is a biopharmaceutical company developing next-generation immunotherapies intended to combat cancer. It was founded in 2019, and is headquartered in Seattle, Washington, USA, with a workforce of 51-200 employees. Its website is http://umoja-biopharma.com.Company H1B SponsorshipUmoja Biopharma has a track record of offering H1B sponsorships, with 1 in 2025, 2 in 2022. Please note that this does not guarantee sponsorship for this specific role. Apply To this Job .