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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
