Sr. Data Manager

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Requirements:

• Bachelor’s degree or higher, preferably in life-science-related fields.
• 8+ years of data management experience in biotech/pharmaceutical industry, or clinical data management service.
• At least three (3+) years in a lead study data manager role.
• Hands-on experience in all phases of clinical trials, including database management and vendor performance.
• In-depth knowledge of CDISC data standards and Good Clinical Data Management Practices (GCDMP).

Responsibilities:

• Lead Data Management of a clinical study or series of related studies with minimal guidance.
• Manage progress of data management activities with CROs, vendors, and statistical/programming groups.
• Review protocols for appropriate data capture, eCRF design, and detailed review of data requirements.
• Develop data edit check specifications and coordinate EDC system design/testing.
• Attend study meetings, review clinical documents, and provide training on data management systems.
• Ensure CRO reconciliation of data and lead database upgrades/migrations.