Clinical Data Manager

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._
- 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._

Clinical Data Manager

PURPOSE OF THE FUNCTION

The CDM is responsible for all data management aspects of the assigned clinical studies from initiation till closure 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.

ROLES AND RESPONSIBILITIES

The CDM will:

- Take a leadership role with the CRO, clinical study team and other internal and external partners to establish, align and conform data management expectations for the assigned trials.
- Set quality expectations and timelines for data management deliverables and will regularly follow up on data management milestones
- Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out.

For the assigned trial(s) the CDM may be asked to:

- Participate in CRO selection and contract negotiations together with the argenx clinical study team and the Vendor Management representative
- Contribute to development of the protocol for the sections relevant for DM (feasibility of data collection, adherence to industry and argenx standards, (interim) locks) and/or review of protocol versions

For the assigned trial(s), the CDM will
- Oversee 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
- Oversee 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
- Facilitate cross-functional review by applicable stakeholders of essential documents and data management deliverables
- Keep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Data Management CRO and Clinical Team.
- Create Data Release Plan in consultation with applicable stakeholders and oversee Data Releases (such as for DSMB/IDMC, interim and final locks, updates after lock) as per plan and blinding rules.
- Participate in User Acceptance Testing Activities for the applicable Data Collection Tools
- Perform adequate Quality Control for data completeness and accuracy
- Contribute to the development in lessons learned and shares best practices within the trial and department.

The CDM will also participate in activities other than study-related
- Lead/participate in initiatives on process improvements
- Participate in regulatory inspections and company audits

SKILLS AND COMPETENCIES
- Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM best practices
- Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF systems, metadata repositories)
- Eye for detail, analytical skills
- Able to work effectively within a team matrix as well as independently
- Strong communication and interpersonal skills
- Fluent in English (written and spoken)

EDUCATION, EXPERIENCE AND QUALIFICATIONS
- Bachelor’s degree or Master’s degree - medical, pa