Manager, Site & Patient Engagement

This role is part of the Site and Patient Engagement team within Trial Operations at argenx. 

The Manager, Site & Patient Engagement is responsible for overseeing, and implementing communication strategies to recruit and retain participants in multiple clinical trials/indications across argenx.   

ROLES AND RESPONSIBILITIES 

Project Management: 

• Collaborate closely with study teams and vendors to ensure successful project execution specific within the scope of S&PE. 

• Oversee the activities of recruitment vendors and manage relationships with communication platform vendors involved in the development of study tools. 

• Lead and manage recruitment and retention strategies for global clinical studies from inception to completion. 

• Develop project plans and timelines in coordination with the Patient Recruitment & Retention Strategy Lead  

• Coordinate with stakeholders to align on project scope and objectives, ensuring smooth execution. 

• Monitor project progress, identifying and implementing adjustments as necessary to achieve project goals.   

Patient Recruitment & Retention 

• Develop site &patient recruitment and retention materials to effectively convey the importance of study participation and adherence.  

• Leverage recommended communication tools and technologies to support the recruitment and retention strategy, where applicable. 

• Ensure all communications are clear, accurate, and compliant with healthcare regulations. 

• Align with Site & Patient Engagement Lead to implement patient recruitment and retention strategies  

Internal Management of Material Development: 

• Facilitate effective communication among CODL’s, CTM’s, GPA, MA and other CTT members to incorporate feedback on relevant materials based on the “Patient Engagement Playbook” 

• Be the first point of contact for all patient recruitment and retention materials for global clinical studies (including study- specific website, lay summaries and any external communication specific to the study, (where applicable) 

• Collaborate with the Patient Recruitment & Retention Strategy Lead to develop and support trial-specific strategies  

External Communication: 

• Manage communication with external stakeholders, including CRO’s, design vendors, recruitment & retention vendors 

• Support the management public-facing study information, such as study websites, plain language summaries (when applicable for a particular study) 

• Design and edit study newsletters/newsflashes in conjunction with the clinical trial team (when applicable) 

• Finalize the layout of study newsletters/newsflashes layout and obtain distribution approval 

• Assist the Clinical Trial Team with the design of presentations Investigator Meeting  

Compliance and Quality Assurance: 

• Ensure all communication practices comply with healthcare regulations and organizational policies 

• Conduct regular reviews and audits of communication processes to maintain high standards of quality and compliance 

Data and Reporting: 

• Collect and analyze data related to recruitment and retention metrics, and report progress to study teams  

• Prepare reports and presentations for clinical trials operations management  

• Identify trends and areas for improvement based on data analysis. 

• Provide recommendations for optimizing recruitment and retention efforts based on data insights. 

Education, Experience and Qualifications 

• Minimum of a BA or BS Degree in scientific, marketing or communications discipline 

• 5-7 years of relevant industry experience (pharma, biotech, CRO) required 

• Thorough understanding of clinical operations  

• Excellent oral and written communication skills and diplomacy to convey information 

• Ability to work collaboratively with multidisciplinary teams in a global environment 

• Excellent written and verbal communication skills. 

• Knowledge of healthcare regulations and compliance standards  

• Auto-immune and/or oncology clinical trial background is a plus 

Skills and Competencies 

• Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical trial 

• Ability to work with vendors and external stakeholders with timely communications 

• Highly organized with a positive attitude; Works well through change and shifting priorities 

• Strong planning, organizational and project management skills 

• Ability to communicate effectively and professionally 

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