Job Details

We are seeking a Clinical Data Manager II to client USMA Data Management team. This role sits within a highly collaborative environment focused on end-to-end data lifecycle management, supporting exploratory research, clinical development, and evidence generation.You will act as a data quality leader, ensuring high-quality, compliant clinical data while driving innovative data solutions aligned with FAIR (Findable, Accessible, Interoperable, Reusable) principles.Key ResponsibilitiesData Management & QualityOversee collection, validation, and curation of clinical and real-world dataDevelop and manage clinical databases ensuring accuracy and integrityPerform high-level data reviews using visualization and statistical monitoring toolsIdentify trends, anomalies, and gaps in datasetsStudy & Project OversightManage timelines, risks, and deliverables across multiple studiesEnsure successful execution of study scope of work (SOW)Maintain accountability for data quality and regulatory compliancePartner with FSPs, CROs, and external vendors to oversee deliverablesManage data transfer agreements and ensure adherence to standardsCollaborate cross-functionally with biometrics, clinical teams, and business stakeholdersDesign and implement fit-for-purpose data solutionsSupport collection of diverse data types (e.g., biomarkers, EMR, sensor data)Contribute to enterprise-wide initiatives and emerging technologiesApply FAIR principles to optimize data usability and accessibilityLeadership & Technical ExpertiseProvide guidance to data management teams and stakeholdersAct as SME for data acquisition, standards, and best practicesRepresent Data Management in study team and data quality meetingsRequired Qualifications5–10 years of Clinical Data Management experienceBachelor's or Master's degree in Life Sciences, Data Science, Bioinformatics, or related fieldStrong knowledge of ICH-GCP and regulatory requirementsExperience with CDISC standards (SDTM preferred)Proven project management and stakeholder management skillsStrong analytical, problem-solving, and communication abilitiesPreferred QualificationsExperience leading DM activities across multiple clinical studiesFamiliarity with EDC systems (e.g., Medidata Rave, Oracle Clinical)Experience with Real World Data (RWD) and advanced data sourcesProficiency in tools/languages such as SAS, R, Python, SQLExperience with data visualization tools (Tableau, Shiny)Knowledge of MedDRA, WHODrug, and advanced analytics (AI/ML)Exposure to big data tools (Hadoop, Spark)#J-18808-Ljbffr