Clinical Trial Lead

Argenx - Remote, OR

Full-time - Mid Level

Remote, OR

Administrative and Support Services

About the position

The Clinical Trial Lead (CTL) at argenx is a pivotal role responsible for overseeing the operational deliverables of global clinical studies from the Final Protocol Concept Sheet to the Clinical Study Report (CSR). The CTL provides strategic insights and cross-functional leadership to ensure trials are executed within quality standards, timelines, and budgets, while adhering to regulatory requirements. This position requires extensive experience in clinical trial operations and the ability to lead teams effectively, driving the operational planning and implementation of assigned studies.

Responsibilities

• Lead cross-functional execution of assigned global clinical trials from preparation until closure.
• Establish and lead the cross-functional Clinical Trial Team (CTT) in partnership with the Lead Trial Physician if assigned as CTT Lead.
• Ensure clinical trials are executed according to protocol requirements, trial plans, and applicable regulations.
• Set expectations and communicate clearly to energize and motivate CTT members and external partners.
• Accountable for delivery of global trials within agreed timelines and budget.
• Oversee cross-functional planning and track study progress, proactively managing trial deliverables and milestones.
• Guide and oversee CROs and other vendors to ensure contractual obligations are met.
• Drive risk identification and mitigation, suggesting solutions and leading contingency planning.
• Ensure accurate trial budget management and timely management of scope changes.
• Develop trial-related materials such as clinical protocols and training materials.
• Monitor data quality and completeness, proactively identifying and resolving issues.
• Partner with Site & Patient Engagement teams on recruitment and retention strategies.

Requirements

• Bachelor's degree or equivalent experience.
• Minimum of 8 years of experience in Clinical Operations, including management and oversight of CROs and vendors.
• Global clinical trial management experience required.
• Strong leadership and interpersonal skills to manage conflict and establish effective relationships.
• Proactive problem-solver with the ability to identify and mitigate risks.
• Excellent written and verbal communication skills in a culturally diverse environment.
• Knowledge of ICH-GCP and other applicable regulations.

Nice-to-haves

• Experience in biotech is a plus.
• Background in rare disease, autoimmune, and/or oncology clinical trials is a plus.

Benefits

• Inclusive work environment with equal consideration for employment.
• Opportunities for professional development and growth.