SlipstreamJobs tracks this role from the company's public career site. Apply directly on the employer's site.
Precision Medicine Group seeks a Senior Clinical Data Associate to provide comprehensive data management support throughout the clinical trial lifecycle, from study initiation through post-database lock. This role operates under direct supervision and follows Standard Operating Procedures, regulatory directives, and study-specific guidelines.
Key responsibilities include:
- Supporting the Lead Data Manager as a backup and team member, ensuring continuity and timely task completion
- Performing data entry for paper-based CRF studies and quality control of entered data
- Developing CRF specifications from clinical study protocols and coordinating stakeholder review and feedback
- Assisting in building and testing clinical databases, including UAT and quality control documentation
- Specifying requirements for various edit check types (electronic, manual review, etc.)
- Creating, revising, and maintaining data management documentation with appropriate versioning
- Training clinical research personnel on study-specific CRFs, EDC systems, and project-related items
- Reviewing and querying clinical trial data according to Data Management Plans
- Performing line listing data reviews and patient/study-level status and metric reporting
- Conducting medical coding of medical terms to ensure medical logic and consistency
- Coordinating SAE/AE reconciliation activities
- Liaising with third-party vendors (data and EDC vendors) in a project-manager capacity
- Assisting with SAS programming and quality control of SAS programs
- Identifying and troubleshooting operational problems based on metrics data and audit reports
- Assisting in reviewing protocols, Statistical Analysis Plans, and Clinical Study Reports as needed
- Participating in development and maintenance of SOPs and process documentation
- Training data management project team members
- Communicating with study sponsors, vendors, and project teams regarding data and database issues
- Presenting software demonstrations, trainings, and departmental sessions
- Possible travel required
Requirements:
Minimum 5+ years of experience in clinical data management. Bachelor's degree and/or combination of related experience required. Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook). Ability to handle diverse clinical research tasks. Excellent organizational and communication skills. Professional English language proficiency (written and oral). Basic knowledge of drug, device, and/or biologic development and effective data management practices. Strong knowledge of ICH-GCP, relevant SOPs, and regulatory guidance.
Preferred qualifications include experience in clinical, scientific, or healthcare disciplines; dictionary medical coding (MedDRA and WHODrug); understanding of CDISC standards (CDASH, SDTM, ADaM); and oncology and/or orphan drug therapeutic experience.
