Clinical Data Manager

• Support all data management activities for research studies in compliance with departmental SOPs and regulatory guidelines
• Review and provide input to study protocols
• Design and develop case report forms (CRFs)
• Develop database specifications and edit check specifications
• Develop and maintain the Data Management Plan
• Develop CRF Completion Guidelines
• Perform User Acceptance Testing
• Conduct data review, query generation and resolution, and third-party data reconciliation
• Identify and review protocol deviations and adverse events
• Identify data trends and resolve data management issues with study personnel and cross-functional teams
• Generate study reports and reports for internal validation and cross-validation studies
• Assist CRAs with preparation for monitoring visits
• Maintain study data, reports, and documentation in the electronic Trial Master File (eTMF)
• Train internal and external personnel in CDMS systems, technology, applications, and data management processes
• Contribute to DM SOPs, Business Guidance, Work Instructions, and Standards
• Attend project and functional group meetings
• Perform routine audits of study files and records
• Provide mentoring and coaching to new hires and junior associates as needed

• Undergraduate degree in a Math, Computer Science, or Life Sciences field required or equivalent combination of education, training and industry related experience
• 3 or more years’ experience supporting clinical research studies within a data management, data analytics, or a data reporting function
• Understanding of database design, data structure, design constraints and cross-functional needs to support clinical trials
• Working knowledge of the clinical research process and regulatory requirements
• Knowledge of data management processes and industry standards
• Experience with Electronic Data Capturing Systems such as Medidata RAVE, Oracle Clinical, Veeva, Open Clinica, iMedNet, or Medrio required
• Knowledge and experience with clinical data reporting tools such as JReview
• Knowledge and skill in using Microsoft Office suite
• Understanding of ICH, ISO, GCP, and GDP guidelines
• Effective project management, analytical, problem-solving, interpersonal, verbal, written communication, organizational, and time management skills
• Ability to work independently with minimal supervision
• Ability to work within cross-functional and highly matrixed teams
• Ability to adapt to changing priorities
• Basic knowledge of SQL preferred
• Basic understanding of SAS concepts preferred

Demonstrates expertise in data management for clinical research, including database design, data reporting, and compliance with regulatory guidelines. Proficient in using Electronic Data Capturing Systems and skilled in project management and communication within cross-functional teams.

• Data Management
• Electronic Data Capturing Systems
• Clinical Research Process
• Project Management
• Database Design

• Database Design
• Data Management Processes
• SQL
• SAS Concepts
• Data Reporting
• User Acceptance Testing
• Case Report Forms Development
• Data Review
• Query Generation
• Adverse Events Identification

• Analytical Skills
• Problem-Solving
• Interpersonal Skills
• Verbal Communication
• Organizational Skills

• ICH Guidelines
• ISO Standards
• GCP Guidelines
• GDP Guidelines
• Clinical Trials

• Medidata RAVE
• Oracle Clinical
• Veeva
• Open Clinica
• IMed Net
• Medrio
• Microsoft Office Suite
• JReview