Clinical Trial Data Management Intern

• Create and ensure successful execution of clinical data management strategies for assigned trials within drug/vaccine programs
• Develop and manage project plans spanning protocol development through database lock, archiving, and submission deliverables where applicable
• Collaborate with functional areas to align resources and execute project plans on time and with appropriate quality
• Manage change, customer, and stakeholder expectations; facilitate cross-functional decision making and perform risk management
• Represent functional areas and Global Data Management on cross-functional trial teams and trial-level development forums
• Serve as a data management lead or support filing programs under guidance of senior staff
• Participate in development of and ensure adherence to clinical data management procedures
• Develop detailed project plans for collection, review, and cleaning of clinical data
• Manage project planning, initiation, execution, change control, closing, team development, leadership, meetings, and resource coordination
• Define trial-level quality data collection and validation requirements
• Read and interpret clinical protocols from a clinical data management perspective
• Provide clinical data management input into trial design
• Assess trial complexity and define data management requirements, inputs, deliverables, and services
• Ensure use of standards and consistency of database design, data collection, and validation
• Approve trial-level data validation plans
• Monitor data quality and completion of database lock and post-database lock activities
• Ensure timely archival of trial data and documentation and decommissioning of clinical data management technologies
• Oversee delivery of data management services from external partners
• Support site and sponsor audits
• Identify and support improvements to data collection and management processes and tools
• Interact with staff across sites, countries, and time zones

• Candidate must be working towards completion of a B.A. or B.S. degree in life sciences, computer science or related discipline
• Candidates must be available to work full-time for up to twelve (12) weeks beginning June 2027
• Candidates must have interest in learning Clinical Data Management
• Basic understanding of the clinical research process for Clinical Data Management lifecycle
• Familiar and comfortable with database concepts and tools to manage, extract, and report data
• Strong organization, leadership, and management skills
• Exceptional oral and written communication skills with the ability to communicate with both technical and business areas
• US and Puerto Rico residents only
• Visa sponsorship is not available
• Valid driving license is not required

Demonstrates expertise in Clinical Data Management strategies, project planning, and execution, with a strong focus on data quality and compliance. Capable of collaborating across functional areas and managing stakeholder expectations effectively.

• Clinical Data Management
• Project Planning
• Data Quality Monitoring
• Cross-Functional Collaboration
• Clinical Research Process

• Database Concepts
• Data Extraction
• Data Reporting
• Data Validation
• Clinical Protocol Interpretation

• Strong Organization Skills
• Leadership Skills
• Exceptional Communication Skills

• Clinical Trials
• Data Management Procedures
• Risk Management
• Stakeholder Management
• Data Collection Processes