Data Management Lead

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back.

argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

The DML is accountable for all Data Management aspects of the assigned compound and/or indication from initiation till closure of activities ensuring that clinical data completeness, accuracy and consistency meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations. The CDML function includes Line Management responsibilities of a team of Clinical Data

Managers (CDM).

Roles and Responsibilities:

Take a leadership role with the CRO and other internal and external partners to establish, align and conform

Data Management expectations for the assigned compound and/or indication

Take a leadership role for Data Management in the Clinical and indication Team, which is ultimately responsible to define the clinical development strategy supporting the Target Product Profile (TPP) across the lifecycle of a compound, starting with the preparation of the “First-in-Human” (FiH) clinical trial throughout

“Registration” and post-approval clinical development activities

Participate in the creation and maintenance of the Clinical Development Plan (CDP) which is describing the clinical development strategy, comprising effective where possible innovative trial designs

Oversee risk identification and risk mitigation strategies for the CDP. Identify risks or deviations from plans and communicate to the Head of Data Management; to the responsible Program Leader (PL) and Management as appropriate, proactively provide solutions and oversee implementation

Set quality expectations and timelines for Data Management deliverables and will regularly follow up on Data

Management milestones. Ensure inspection readiness at all times

Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out

Set expectations, communicate in a transparent, clear way and motivate team members to work towards achieving the clinical goals in line with the OGSM and the cultural pillars

For the assigned compounds/indication(s) the CDML will:

Oversee the CRO selection and contract negotiations

Support the Clinical Data Portfolio Lead in keeping the oversight of the clinical budget for the assigned indication/program, collaborate with the CDMs and

Statisticians to make sure the budgets are prepared, reviewed and updated within the forecast timelines as agreed with the PL and finance. Ensure that the trials and assigned clinical activities are executed within the agreed budget. Pro-actively escalate to the PL

Contribute to development of the protocol for the sections relevant for Data Management (feasibility of data collection, adherence to industry and argenx standards, (interim) locks) and/or review of protocol versions

For the assigned trial(s) under the compound/indication, the CDML will:

Ensure oversight of all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:

Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)

Creation of essential documents (DMP, UAT documents)

Creation of submission ready clinical data package per regulatory agencies requirements

Creation of archival package of clinical data per argenx requirements

Ensure oversight of all activities related to Data Management:

Ensure that Data Management essential documents are written in a timely manner and of such quality to allow the evaluation of the conduct of a trial and the quality of the data produced

Keep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Head of

Data Management, CDM, Data Management CRO and Clinical Team as appropriate

Ensure consistency between trials on compound/indication level

Leverages learnings and shares best practices within the indication and department

The CDML will also participate in activities other than study-related:

Lead/participate in initiatives on process improvements

Participate in regulatory inspections and company audits

Line Management of CDMs and full on-boarding of new direct reports

Ensure that assigned staff is adequately trained and that training is documented

Mentor and enable the growth and development of assigned staff

Collaborate with Clinical Data Portfolio Lead for own goal setting and goal review as well as of the direct reports

Skills and Competencies:

Able to work effectively within a team matrix as well as independently

Strong communication and interpersonal skills

Fluent in English (written and spoken)

Able to motivate and manage team members with the ability to prioritize tasks and organize workload

Natural Leader with the ability to work independently

Strong people management skills, leader and team player

Education, Experience and Qualifications:

Bachelor’s degree or Master’s degree – medical, para-medical (Biology, Biomedical Sciences, Pharmacy,

Veterinary etc.), mathematics or equivalent by experience

Demonstrated experience in Clinical Data Management and in managing CROs and vendors

Biotech experience is a plus

Auto-immune and/or orphan disease clinical study background is a plus

Line management experience is a plus



Note: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location.


This job is eligible to participate in our short-term and long-term incentives program.

The hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job-related knowledge and demonstrated skills.

argenx may pay more or less than the posted range and this range may be modified in the future.

At argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.

argenx is proud to be an equal opportunity employer.

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