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:

• Masters or Bachelors 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.