Job details
Job type full-time
Full job description
Key accountabilities/responsibilities: the clinical data manager (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 regulationsThe 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 kpisAdjust 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
Bachelor’s or master’s degree (biology, biomedical sciences, pharmacy, mathematics, etc.) or equivalent experience
Demonstrated experience in clinical data management
Experience in managing cros and vendors
Auto-immune and/or orphan disease clinical study background is a plus
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Argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancerPartnering with leading academic researchers through its immunology innovation program (iip), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicinesArgenx is evaluating efgartigimod in multiple serious autoimmune diseasesArgenx is also advancing several earlier stage experimental medicines within its therapeutic franchisesArgenx has offices in belgium, the united states, japan, and switzerland.
