Clinical Data Management Lead - Strategy & Trials

argenx SE

Oost-Vlaanderen

On-site

EUR 100,000 - 150,000

Full time

5 days ago

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Job summary

argenx SE is seeking a senior Clinical Data Management Leader (CDML) to drive data management across trials and CRO collaborations. You will define data collection strategies, ensure data integrity, and uphold regulatory readiness throughout the lifecycle of multiple indications.

You will mentor CDMs, manage budgets, and collaborate closely with clinical teams to enable successful regulatory submissions. The role requires a strong background in Clinical Data Management, CRO oversight, and

Qualifications

Bachelor’s or Master’s degree in life sciences or related field.
Demonstrated experience in Clinical Data Management and managing CROs/vendors.
Biotech experience is a plus; autoimmune study background is a plus.

Responsibilities

Lead Data Management with CROs and internal partners; align expectations.
Lead Data Management within clinical teams; define strategy across lifecycle.
Contribute to Clinical Development Plan and data collection strategies.
Identify and mitigate risks in CDP; communicate solutions to leadership.
Set quality standards and timelines for Data Management deliverables; track milestones.
Ensure inspection readiness and regulatory compliance from start to close.
Mentor CDMs; manage line reports; ensure training and onboarding.
Oversee budget for assigned indications and collaboration with PL and finance.
Oversee data management activities for outsourced CROs and trial data packages.
Collaborate on protocol development for data management components.