eCOA Operations Lead

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. 

The eCOA Operations Lead serves as a functional subject matter expert (SME) in the field of electronic Clinical Outcome Assessments (eCOA), driving process optimization, standardization, and operational excellence across clinical programs. This role collaborates closely with internal partners, such as Global Clinical Operations, Clinical Development, HEOR, Program Management, Quality, Legal and Regulatory Affairs, as well as external partners (CROs, eCOA Vendors, etc.) to enhance efficiency and effectiveness in eCOA implementation across the argenx portfolio.

By providing strategic oversight, governance, and continuous process improvements, the eCOA Operations Lead ensures eCOA solutions are seamlessly integrated, efficiently deployed, fully compliant with regulatory requirements, and enhance the patient and site experience to ensure an optimal level of robustness for data captured via eCOA.

ROLES AND RESPONSIBILITIES:

Strategic Leadership & eCOA Framework Development

• Lead cross-functional teams in the development, optimization, and execution of eCOA frameworks to ensure efficiency, compliance, and seamless trial execution.

• Serve as an eCOA SME across the organization, providing expert guidance throughout the end-to-end (E2E) process to ensure best practices and regulatory compliance.

• Establish and maintain governance and operational models to drive eCOA standardization, ensuring global consistency across the portfolio.

• Develop KPIs and metrics dashboard and conduct Portfolio Oversight Meetings with CROs and third-party vendors to proactively monitor performance, resolve challenges, and continuously enhance eCOA implementation strategies.

• Consulted in the resolution of eCOA-related issues, particularly those with cross-portfolio impact. Instrumental in the sharing of eCOA lessons learned.

• Evaluate new vendor capabilities and technology roadmaps to ensure compatibility with the evolving needs of argenx.

Process Optimization & Documentation

• Develop and implement process documentation and oversight frameworks for eCOA governance, ensuring alignment with regulatory expectations and internal quality standards.

• Establish and maintain a centralized eCOA portal, facilitating knowledge sharing, resource accessibility, and ongoing landscape monitoring.

• Oversee third-party vendors for copyright, translations, and library services, ensuring compliance with licensing agreements and regulatory requirements.

Training & Stakeholder Engagement

• Design and implement a comprehensive training program to enhance internal expertise on eCOA processes, compliance requirements, and industry best practices.

• Drive patient and site engagement strategies by embedding structured journey mapping templates (enabling evaluation of protocol-specific eCOA processes) and tailored training initiatives, ensuring an optimized patient & site experience.

• Provide ongoing internal advisory support to key stakeholders, offering insights on eCOA advancements, challenges, and evolving regulatory landscapes.

Regulatory Compliance & Inspection Readiness

• Ensure continuous regulatory inspection readiness, maintaining complete documentation (including eCOA training), audit trails, and compliance with global regulatory requirements (ICH-GCP, FDA, EMA, and industry guidelines).

• Stay ahead of eCOA industry trends, regulatory updates, and technological advancements, proactively adapting strategies to maintain compliance and competitive advantage.

SKILLS AND COMPETENCIES:

• Expert knowledge of eCOA methodologies, regulatory guidelines (ICH-GCP, FDA, EMA), and industry best practices.

• Deep understanding of eCOA systems, technical implementation, and operational workflows.

• Strong analytical skills and attention to detail to identify and resolve issues proactively.

• Ability to work independently and cross-functionally, lead complex initiatives with minimal oversight, and effectively influence change.

• Excellent communication, stakeholder management, and interpersonal skills.

• Fluent in English (written and spoken).

EDUCATION, EXPERIENCE AND QUALIFICATIONS:

• Master’s or Bachelor’s degree in Life Sciences, or a related field, or equivalent experience.

• Minimum 8 years of experience in clinical trials within the pharmaceutical or biotechnology industry, with direct eCOA implementation responsibilities.

• Proven expertise in system implementation, vendor management, and process development of eCOA.

• Strong project management and leadership skills, with a track record of driving operational efficiency.

• In-depth understanding of clinical development processes and regulatory frameworks governing eCOA solutions.

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