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.
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