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Lead Clinical Data Manager

Karwell Technologies

Omaha, NE

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JOB DETAILS
SKILLS
Analysis Skills, Artificial Intelligence (AI), Best Practices, Biology, Biostatistics, Biotech and Pharmaceutical, Budgeting, Case Report Form (CRF), Clinical Data, Clinical Data Collection, Clinical Data Interchange Standards Consortium (CDISC), Clinical Data Management, Clinical Research, Clinical Trial, Clinical Trial Management, Clinical Validation, Computer Science, Contract Research Organization (CRO), Cross-Functional, Data Management, Data Quality, Detail Oriented, Drug Development, Electronic Data Capture (EDC), Emerging Technology, FDA (Food and Drug Administration), GCP (Good Clinical Practices), Industry/Trade Analysis, Interpersonal Skills, Maintain Compliance, Management Strategy, Microsoft Office, Oncology, Performance Analysis, Performance Management, Pharmacovigilance, Problem Solving Skills, Project/Program Management, Quality Metrics, R Programming Language, Regulations, Regulatory Requirements, Research Protocols, Risk Management, Set Goals, Standard Operating Procedures (SOP), Statistical Analysis System (SAS), Statistics Software, Strategic Planning, Systems Administration/Management, Team Player, Trend Analysis, Validation Plan, Validation Testing, Wearables
LOCATION
Omaha, NE
POSTED
30+ days ago
Responsibilities:
  • Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards.
  • Provide strategic oversight and direction to CRO clinical data management teams for assigned studies.
  • Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.
  • Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality.
  • Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes.
  • Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals.
  • Provide oversight, and performance management of external data management vendors.
  • Maintain SOPs, guidelines, and best practices for clinical data management processes.
  • Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters.
  • Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field.
Requirements:
  • Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred.
  • A minimum of 7+ years of clinical data management experience in the biotechnology or pharmaceutical industry.
  • Experience managing oncology clinical trials data, including a deep understanding of oncology-specific data requirements and challenges.
  • Expert-level proficiency with Medidata Rave EDC, including system configuration, form design, and edit check programming.
  • Strong knowledge of clinical research processes, FDA & ICH guidelines, GCP, GCDMP, and CDISC standards.
  • Demonstrated experience in CRO and vendor oversight.
  • Excellent project management skills with the ability to manage multiple studies simultaneously.
  • Strong analytical and problem-solving skills with meticulous attention to detail.
  • Outstanding communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders.
  • Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g., SAS, R) is a plus.
  • CCDM (Certified Clinical Data Manager) certification.
  • Experience with risk-based monitoring in oncology studies.
  • Knowledge of emerging technologies in clinical data collection and management (e.g., ePRO, wearables, AI/ML applications).

About the Company

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Karwell Technologies

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