Senior Clinical Data Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Data Manager based in United States.

This role plays a critical part in driving the integrity, structure, and reliability of clinical trial data across a fast-evolving medical technology environment.
You will lead sponsor-side clinical data management activities supporting end-to-end study execution across multiple clinical programs.
The position ensures that databases, data workflows, and validation processes are designed to meet the highest standards of accuracy, traceability, and regulatory compliance.
You will collaborate closely with cross-functional teams, including data science and machine learning specialists, to enable high-quality clinical insights and submissions.
The environment is highly collaborative and innovation-driven, with a strong emphasis on modern data systems and AI-enabled processes.
This role is ideal for someone who thrives in a regulated, detail-oriented setting while contributing to breakthrough healthcare technologies.

• Lead the design, build, and configuration of clinical study databases (EDC, CTMS, eTMF), including eCRF design, annotations, and edit check specifications.
• Execute and document user acceptance testing for clinical databases, manage amendments, and ensure version control across the study lifecycle.
• Develop and maintain data management plans, CRF completion guidelines, and data review strategies to ensure high-quality clinical data.
• Oversee ongoing data review activities, query management, discrepancy resolution, and data cleaning processes.
• Manage user access, role-based permissions, audit trails, and compliance with regulatory access control requirements.
• Coordinate database lock activities, including final data reconciliation and submission readiness.
• Act as subject matter expert for regulatory standards and ensure inspection readiness across all data management processes.
• Manage vendor and CRO relationships, including deliverables, timelines, budgets, and performance tracking.
• Partner with cross-functional teams to support clinical, regulatory, and data science initiatives.

Requirements:

• Bachelor’s degree with 5+ years of experience in clinical data management, including leadership of end-to-end data management activities.
• Strong experience in sponsor-side clinical trials within biotech, pharmaceutical, or medical device environments.
• Hands-on expertise in eCRF design, database build, edit checks, and UAT execution.
• Solid knowledge of EDC/CDMS systems, eTMF management, and access control compliance (21 CFR Part 11).
• Strong understanding of regulatory frameworks including GCP, ICH E6(R3), ISO 14155, and 21 CFR Part 812.
• Experience managing external vendors and CROs in clinical trial settings.
• Excellent communication, organizational, and problem-solving skills with the ability to manage multiple priorities.
• Preferred: CCDM or SCDM certification, exposure to medical device submissions (510(k), PMA), and familiarity with SAS or R.

Benefits:

• Company equity plan
• Annual unlimited paid time off
• Health insurance with 50 percent employer contribution to monthly premiums (Blue Cross network)
• Dental insurance with 50 percent employer contribution
• Vision insurance with 50 percent employer contribution
• 401(k) plan with up to 3 percent employer match
• Mental health and wellbeing resources