Senior Clinical Data Manager
New
J
JobgetherPharmaceutical, Biotechnology
Based in United StatesFull-TimeSenior
Salary110,000 - 130,000 USD per year
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Job Details
- Experience
- 8+ years of professional experience
- Required Skills
- Project ManagementMicrosoft Excel
Requirements
- Bachelor’s degree in Pharmaceutical Sciences, Biotechnology, or another health-related field; an advanced degree is preferred.
- 8+ years of professional experience in clinical data management, preferably within a CRO, pharmaceutical, biotechnology, or related life sciences environment.
- Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and applicable clinical data management standards.
- Demonstrated experience with EDC systems and clinical data management platforms, including database setup, data review, validation, cleaning, and reconciliation activities.
- Strong project management and study leadership capabilities, including work planning, delegation, prioritization, and oversight of multiple stakeholders.
- Experience working with clinical trial databases, external data sources, edit checks, queries, data validation specifications, and database freeze/lock processes.
- Strong analytical skills with the ability to identify data trends, investigate issues, and translate findings into practical actions.
- Excellent written and verbal communication skills, with confidence engaging sponsors, global study teams, investigators, and internal stakeholders.
- Proficiency in Microsoft Office, particularly Microsoft Excel and Microsoft Project.
- Strong organizational skills and attention to detail, with the ability to manage competing priorities while maintaining high-quality deliverables.
Responsibilities
- Lead assigned clinical data management studies independently, overseeing databases and data management activities throughout the full study lifecycle.
- Serve as the primary liaison for sponsor and internal data management interactions, maintaining strong communication and alignment across global study teams.
- Monitor study timelines, deliverables, quality standards, and data management performance to ensure projects remain on track.
- Oversee and/or develop key data management documentation, including Data Management Plans, eCRF completion guidelines, CRFs, help text, validation specifications, and testing plans.
- Lead or support database design, user-role configuration, edit checks, internal system testing, user acceptance testing, database changes, and implementation activities.
- Oversee data review, quality control, query management, vendor data reconciliation, exception reporting, and overall data consistency and accuracy.
- Identify data issues and trends, communicate findings to study teams and sponsors, and support the development and implementation of corrective action plans.
- Delegate responsibilities, provide guidance to study team members, mentor junior colleagues, and support effective workload planning across projects.
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