Senior Clinical Data Manager

Responsibilities

• Independently lead data management study activities, CRO oversight, and drive deliverable timelines.
• Represent data management on the Clinical Sub-team to ensure aligned expectations between CRO and client for all data-related deliverables, especially for key decision points and regulatory submissions.
• Contribute influential leadership in collaboration with other client stakeholders to ensure milestones and deliverables are met with high quality.
• Partner with stakeholders and CRO partners to mitigate and resolve risks.
• Provide input to functional governance with client strategic suppliers; resolve issues escalated from vendor and cross-functional teams.
• Prepare function for submission readiness and may represent function in inspections or audits.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Ensure achievement of major data management deliverables and milestones in coordination with Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
• Plan and manage external Data Management budgets and timelines, monitor variances, and support continuous improvement in forecasting.
• Act as a process expert for operational and oversight models.
• Maintain SOPs, process maps, templates, and timelines to support operational and oversight models.
• May prepare metrics to support the function’s KPIs.
• Represent the function in external professional initiatives and organizations (e.g., SCDM, CDISC, DIA) to identify industry best practices and raise client visibility.
• Contribute to functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines and budgets and align with requirements.
• Ensure compliance with Learning Curricula, corporate and GXP requirements.
• Work cross-functionally to ensure data quality in each database and on-time delivery of data management deliverables.
• Perform other duties as assigned.

Qualifications

Additional details

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