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 Responsibilities Data Management & Quality Oversee collection, validation, and curation of clinical and real-world data Develop and manage clinical databases ensuring accuracy and integrity Perform high-level data reviews using visualization and statistical monitoring tools Identify trends, anomalies, and gaps in datasets Study & Project Oversight Manage timelines, risks, and deliverables across multiple studies Ensure successful execution of study scope of work (SOW) Maintain accountability for data quality and regulatory compliance Partner with FSPs, CROs, and external vendors to oversee deliverables Manage data transfer agreements and ensure adherence to standards Collaborate cross-functionally with biometrics, clinical teams, and business stakeholders Design and implement fit-for-purpose data solutions Support collection of diverse data types (e.g., biomarkers, EMR, sensor data) Contribute to enterprise-wide initiatives and emerging technologies Apply FAIR principles to optimize data usability and accessibility Leadership & Technical Expertise Provide guidance to data management teams and stakeholders Act as SME for data acquisition, standards, and best practices Represent Data Management in study team and data quality meetings Required Qualifications 5–10 years of Clinical Data Management experience Bachelor’s or Master’s degree in Life Sciences, Data Science, Bioinformatics, or related field Strong knowledge of ICH-GCP and regulatory requirements Experience with CDISC standards (SDTM preferred) Proven project management and stakeholder management skills Strong analytical, problem-solving, and communication abilities Preferred Qualifications Experience leading DM activities across multiple clinical studies Familiarity with EDC systems (e.g., Medidata Rave, Oracle Clinical) Experience with Real World Data (RWD) and advanced data sources Proficiency in tools/languages such as SAS, R, Python, SQL Experience 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 SPECTRAFORCE
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