Responsibilities
- Design and implement data management plans for clinical trials
- Develop and maintain data management documentation, including data management plans and standard operating procedures
- Coordinate with cross-functional teams to ensure data collection and database design meet study requirements
- Conduct data validation and quality control checks to ensure data integrity
- Manage and track all data management activities, including data entry, data coding, and data cleaning
- Troubleshoot data-related issues and provide solutions to ensure timely and accurate data delivery
- Collaborate with statisticians and clinical teams to support data analysis and reporting
- Ensure compliance with regulatory requirements and industry best practices in data management
- Stay up-to-date with the latest developments and trends in clinical data management
Qualifications
- Bachelor's degree in life sciences, biostatistics, or a related field
- Strong knowledge of clinical data management principles and practices
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS)
- Familiarity with regulatory guidelines (e.g., FDA, ICH, GCP) and data standards (CDISC)
- Excellent attention to detail and problem-solving skills
- Ability to work effectively in a fast-paced and deadline-driven environment
- Strong communication and interpersonal skills
- Experience with data management software and tools (e.g., SAS, R, SQL)
- Certification in clinical data management (e.g., CCDM) is a plus
Skills
- Clinical data management
- Data validation
- Data cleaning
- Database design
- Regulatory compliance
- Statistical analysis
- Problem-solving
- Attention to detail
- Interpersonal skills
- Technical skills (SAS, R, SQL)