Clinical Data Manager (CDM)
For the expansion of our clinical team, argenx is looking for a Clinical Data Manager (CDM).
argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development.
argenx is evaluating our lead candidate, efgartigimod, in multiple serious autoimmune indications and cusatuzumab in hematological malignancies in collaboration with Janssen, along with advancing earlier stage assets within its therapeutic franchises.
What we are looking for
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.
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
Desired Skills and Experience:
- 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)
- 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
- Experience in managing CROs and vendors is a plus
- Biotech experience is a plus
- Auto-immune and/or orphan disease clinical study background is a plus
- A competitive salary package with benefits;
- A work environment in a human-sized, dynamic, rapidly growing biotech company