- 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
Requirements
- 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
Core Competencies
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.
Highest-signal resume keywords
- Clinical Data Management
- Project Planning
- Data Quality Monitoring
- Cross-Functional Collaboration
- Clinical Research Process
ATS Optimization Keywords
Hard Skills
- Database Concepts
- Data Extraction
- Data Reporting
- Data Validation
- Clinical Protocol Interpretation
Soft Skills
- Strong Organization Skills
- Leadership Skills
- Exceptional Communication Skills
Industry Keywords
- Clinical Trials
- Data Management Procedures
- Risk Management
- Stakeholder Management
- Data Collection Processes