[Remote] Clinical Data Manager

Note: The job is a remote job and is open to candidates in USA. Sumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various health domains. The Clinical Data Manager will oversee clinical data management activities for oncology studies, ensuring high-quality and compliant clinical trial data in collaboration with cross-functional teams.ResponsibilitiesExecute and manage all in house clinical data management activities for assigned oncology trials in accordance with ICH/GCP, regulatory requirements, and internal SOPsSupport and contribute to the oversight of CROs and data management vendors, including review of deliverables, metrics, timelines, and issue escalationPerform and/or oversee database build, edit check specification review, UAT planning and execution, database modifications, and database lock activitiesConduct ongoing data review, cleaning, query management, and quality control to ensure data accuracy, consistency, and completenessDevelop, review, and maintain Data Management deliverables, including:Data Management Plans (DMPs)CRF Completion GuidelinesData Validation SpecificationsData Transfer SpecificationsMonitor study status metrics (e.g., enrollment, eCRF completion, query aging) and provide regular data management status updates to study teams and functional leadershipCollaborate cross functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to support data reconciliation, analysis readiness, and submission activitiesIdentify operational risks, trends, and data quality issues using metrics, audits, and study insights, and partner with teams to implement corrective actionsSupport inspection readiness activities, audits, and regulatory inquiries related to clinical data managementEnsure adherence to Data Management standards, processes, and best practicesPerform other data management–related duties as required to support departmental and organizational objectivesSkillsExecute and manage all in house clinical data management activities for assigned oncology trials in accordance with ICH/GCP, regulatory requirements, and internal SOPsSupport and contribute to the oversight of CROs and data management vendors, including review of deliverables, metrics, timelines, and issue escalationPerform and/or oversee database build, edit check specification review, UAT planning and execution, database modifications, and database lock activitiesConduct ongoing data review, cleaning, query management, and quality control to ensure data accuracy, consistency, and completenessDevelop, review, and maintain Data Management deliverables, including Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, Data Transfer SpecificationsMonitor study status metrics (e.g., enrollment, eCRF completion, query aging) and provide regular data management status updates to study teams and functional leadershipCollaborate cross functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to support data reconciliation, analysis readiness, and submission activitiesIdentify operational risks, trends, and data quality issues using metrics, audits, and study insights, and partner with teams to implement corrective actionsSupport inspection readiness activities, audits, and regulatory inquiries related to clinical data managementEnsure adherence to Data Management standards, processes, and best practicesPerform other data management–related duties as required to support departmental and organizational objectivesStrong working knowledge of clinical data management processes, clinical trial conduct, and regulatory requirements (ICH, GCP)Experience with EDC systems, eCRF design, edit checks, data validation, and database lock processesAbility to analyze data trends, metrics, and operational risks to inform decision‑makingStrong organizational skills with the ability to manage multiple priorities in a fast‑paced environmentEffective verbal and written communication skills and ability to collaborate cross‑functionallyHigh attention to detail, problem‑solving skills, and sound judgmentAbility to work independently while contributing effectively as part of a matrixed team environmentBachelor's degree in a scientific, health‑related, or quantitative discipline requiredMinimum 4 years of relevant clinical data management experience in the pharmaceutical or biotech industry, with at least 2 years in a Clinical Data Manager roleUnderstanding of oncology clinical trials, endpoints, and data flow preferredOncology experience preferredBenefitsMerit-based salary increasesShort incentive plan participationEligibility for our 401(k) planMedical, dental, vision, life and disability insurancesLeaves provided in line with your work stateFlexible paid time off11 paid holidays plus additional time off for a shut-down period during the last week of December80 hours of paid sick time upon hire and each year thereafterCompany OverviewSumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS. It was founded in 2023, and is headquartered in Marlborough, Massachusetts, US, with a workforce of 1001-5000 employees. Its website is .Company H1B SponsorshipSumitomo Pharma America, Inc. has a track record of offering H1B sponsorships, with 1 in 2026, 8 in 2025, 9 in 2024, 14 in 2023. Please note that this does not guarantee sponsorship for this specific role.