Offer summary

Qualifications:

Master’s or Bachelor’s degree in Biomedical or similar field, or equivalent experience., At least 8 years of experience in Clinical Data Management, preferably in biotech., Expertise in eCOA data and processes within a biotech or pharma organization., Strong knowledge of CDISC standards and regulatory guidelines..

Key responsabilities:

Lead cross-functional teams to establish eCOA data standards and mappings.

Support eCOA data ingestion and standardization processes linked to clinical endpoints.

Serve as the primary contact for eCOA technology and integration issues.

Optimize data acquisition processes in clinical trials to enhance efficiency and quality.

Job description

At argenx, we believe the future belongs to the curious—those who aren't afraid to explore, ask unposed questions, and listen with open minds. We set audacious, ambitious goals and, together, dare to achieve them. If you're entrepreneurial, committed to making a difference for patients, and thrive on creating solutions for some of the toughest autoimmune diseases, then argenx is for you. Join us and be part of a team driven by creativity, innovation, and science.

eCOA Standards Manager

PURPOSE OF THE FUNCTION

The eCOA Standards Manager is a functional expert in the field of electronic clinical outcome assessments (eCOA) data ingestion and standardization. The eCOA Standards Manager works in close collaboration with the Trial Ops eCOA Lead, Health Economics Outcomes Research (HEOR) and Global Sourcing and Vendor Alliance Management SME to drive eCOA efficiency across the argenx portfolio.

REPORTING LINE

The eCOA Standards Manager will report directly to the Head of Data Standards (Data Acquisition) and have a dotted-line reporting relationship to the Trial Ops eCOA Lead.

ROLES AND RESPONSIBILITIES

The eCOA Standards Manager will:

Take a leadership role in cross-functional teams to create standards for eCOA data, standardized Data Transfer Agreements (DTA’s) and (SDTM) data mappings.
Support portfolio on all aspects of eCOA data ingestion, standardization, linking with clinical endpoints, etc.
Ensures CDISC compliant mapping of COA data by creating & maintaining a library of SDTM metadata for COA’s.
Serve as Lead for eCOA technology / systems and integrations
Escalation point for study-specific eCOA 'DM-related' issues.
Serve as eCOA Lead for argenx Near Real Time Data Flow i.e. weekly eCOA vendor transfers for internal SDTM creation; QC & insight generation tools.
Provide support to optimize data acquisition process in clinical trials by exploring opportunities to streamline and integrate data, enhancing efficiency and data quality.
Stay abreast of regulatory requirements and new industry trends and technologies concerning COAs, and inform relevant stakeholders if needed.
Participate in regulatory agency inspections and internal audits, when appropriate.

SKILLS AND COMPETENCIES

Knowledge of ICH-GCP and other applicable legislation
CDISC standards (SDTM)
Eye for detail, analytical skills
Able to work independently
Strong communication and interpersonal skills
Fluent in English (written and spoken)

EDUCATION, EXPERIENCE AND QUALIFICATIONS

Master’s or Bachelor’s degree in Biomedical or similar, or equivalent by experience
At least 8 years experience in Clinical Data Management (Biotech experience is a plus)
Experience with eCOA data as Subject Matter Expert in a biotech or pharma organization
Knowledge of (e)COA processes and systems
Experience of working in a Data Standards team
In depth understanding of Clinical Development processes
Good knowledge of the applicable regulatory guidelines

Required profile