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…