Senior Clinical Data Manager

Senior Clinical Data Manager – Cytel

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• Lead data management study activities, oversee CRO, and drive deliverable timelines.
• Utilize RAVE for EDC builds and possess strong knowledge of related technologies.
• Represent the data management function on the Clinical Sub‑team, aligning expectations between CRO and client for all data‑related deliverables, especially regulatory submissions.
• Provide influential leadership with stakeholders to ensure milestones and deliverables meet the highest quality standards.
• Partner with stakeholders and CRO partners to mitigate and resolve risks.
• Input to functional governance with client strategic suppliers and resolve escalated issues from vendors or cross‑functional teams.
• Prepare the function for submission readiness, represent the function in formal inspections or audits.
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Coordinate with Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics to achieve major data management deliverables and milestones.
• Plan and manage external Data Management budgets and timelines, analyze variances, and support continuous improvement in forecasting.
• Act as a process expert for operational and oversight models.
• Maintain SOPs, process maps, templates, and timelines that support operational models.
• Prepare metrics to support the function’s KPIs.
• Represent the function in external professional initiatives and organizations such as SCDM, CDISC, DIA, and others.
• Contribute to continuous improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget and company or functional requirements.
• Ensure compliance with learning curricula, corporate, and GXP requirements.
• Work cross‑functionally to ensure data quality in each database and timely delivery of other 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.
• At least 2 years as a CDM lead.
• Experience with all phases of development.
• Strong knowledge of data management best practices and technologies.

Mid‑Senior level

Full‑time

Research, Analyst, and Information Technology

Pharmaceutical Manufacturing

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