Clinical Data Management Leader – Biotech Trials

Argenx; Oost-Vlaanderen; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

argenx is seeking a Clinical Data Management Lead (CDML) to drive data management across assigned compounds and indications. You will partner with CROs and internal teams to establish data management expectations, standards, and timelines aligned with a strong clinical development strategy.

You will oversee the clinical data portfolio, budgets, and regulatory readiness, mentor CDMs, and ensure high-quality data deliverables from trial initiation through close-out.

Qualifications

• Lead Data Management efforts across compounds/indications coordinating with CROs and internal teams.
• Oversee development and management of the Clinical Data Plan (CDP) and budget for assigned indications.
• Ensure compliance with SOPs and regulatory requirements from trial start-up to close-out.

Responsabilités

• Lead the Data Management function for the assigned compound/indication, aligning CROs and internal partners.
• Oversee CRO selection, contracting, and oversight for data management activities.
• Contribute to protocol development relevant to Data Management (feasibility, data collection, interim locks).
• Oversee outsourced Data Management deliverables (SOW, data collection tools, DMP, UAT, archival packages).
• Ensure data management documents are prepared timely and of high quality to support trial conduct and data quality.
• Monitor project plans, budgets, metrics and KPIs; adjust plans with the Head of Data Management and stakeholders.
• Line manage CDMs, onboard new staff, and ensure training is documented.
• Share learnings and best practices across indications and departments.

Description du poste

argenx is seeking a Clinical Data Management Lead (CDML) to drive data management across assigned compounds and indications. You will partner with CROs and internal teams to establish data management expectations, standards, and timelines aligned with a strong clinical development strategy.

You will oversee the clinical data portfolio, budgets, and regulatory readiness, mentor CDMs, and ensure high-quality data deliverables from trial initiation through close-out.