Senior Clinical Data Manager — Remote Impact

The Emmes Company, LLC; Rockville (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

The Emmes Group is seeking a Principal Clinical Data Manager to lead data management activities across clinical studies. This remote role focuses on designing and overseeing EDC data collection, CRF development, and data validation to ensure high-quality datasets for analyses.

The role requires extensive experience in clinical data management, strong leadership, and the ability to mentor DM staff while collaborating with cross-functional teams to drive regulatory compliant deliverables and

Qualifications

• Bachelor's Degree in scientific discipline preferred with working knowledge of clinical terminology and methods.
• 7-9 years data management experience required.
• 4-6 years MS in scientific discipline with basic understanding of clinical development preferred.
• Strong knowledge of clinical trial design, adaptive designs, survival analysis and related methods.

Responsibilities

• Serves as lead point of contact for design, documentation, testing and implementation of clinical data collection studies in an EDC system.
• Oversees creation/review of study-specific CRFs with strong technical knowledge and standards.
• Determines data collection requirements at project level and drives development.
• Analyzes data management issues/risks and recommends solutions.
• Approves/reviews data management plans and templates (e.g., DMA, DMP, DVP, EDC User Guide).
• Leads data reviews with DM team to ensure accuracy and creates corrective action plans.
• Mentors DM staff in leadership, project management and internal processes.
• Authors/reviews data reports and presents data as applicable.

Job description

The Emmes Group is seeking a Principal Clinical Data Manager to lead data management activities across clinical studies. This remote role focuses on designing and overseeing EDC data collection, CRF development, and data validation to ensure high-quality datasets for analyses.

The role requires extensive experience in clinical data management, strong leadership, and the ability to mentor DM staff while collaborating with cross-functional teams to drive regulatory compliant deliverables and