Senior Clinical Data Manager
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Job Description
Senior Clinical Data Manager leading RAVE-based clinical data operations at Cytel. Overseeing CRO deliverables, data quality, audits, budgets, timelines, and regulatory readiness.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- Commitment to developing staff and supporting significant professional growth
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