Senior Clinical Data Manager

Clinical Outcomes Solutions · via Devremote

🌎 Remote ⌛ Posted 2 days ago

Independently lead data management study activities, CRO oversight, and deliverable timelines
Build EDC systems utilizing RAVE
Represent data management on the Clinical Sub-team and align CRO and client expectations for data deliverables
Collaborate with stakeholders to meet milestones and deliverables with high quality
Partner with stakeholders and CRO partners to mitigate and resolve risks
Support functional governance with strategic suppliers and resolve escalated issues
Prepare the function for submission readiness and represent it in inspections or audits
Maintain archival and inspection readiness of Data Management Trial Master File documents
Coordinate data management deliverables and milestones with Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics
Plan and manage external Data Management budgets and timelines, including variance analysis and forecasting
Act as a process expert for operational and oversight models
Maintain SOPs, process maps, templates, and timelines
Prepare metrics supporting functional KPIs
Represent the function in external professional initiatives and organizations such as SCDM, CDISC, and DIA
Contribute strategic direction to continuous improvement initiatives
Ensure compliance with learning curricula, corporate, and GXP requirements
Work cross-functionally to ensure database data quality, on-time delivery, and quality of data management deliverables
Perform other duties as assigned

Proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience
Bachelor's Degree in a science, health related, or IT field
Minimum 6 years' experience in Clinical Data Management at the CRO or pharma level
2 years as a CDM lead
Experience with all phases of development
Strong knowledge of data management best practices and technologies
Experience with Elluminate is preferred, not required

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