Global Study Operations Manager
hace 4 horas
Company Overview
Argenx is a leading biotechnology company dedicated to developing innovative treatments for patients with severe autoimmune diseases.
Salary
We offer a competitive salary of $120,000 - $180,000 per year, depending on experience.
Job Responsibilities
- Manage the operational activities of post-marketing studies globally, excluding Japan, in compliance with regulatory requirements.
- Plan, coordinate, and manage the selection and operations of CROs and other study vendors.
- Drive the conduct of PMRs or non-interventional safety studies, ensuring study milestones are met in accordance with protocols and regulatory requirements.
- Manage project planning and budgeting as related to PMRs.
- Maintain trackers, metrics, and progress reports regarding budget, timelines, deliverables, and documentation.
- Ensure timely collection, documentation, and reporting of Adverse Events (AEs) and Serious AEs.
- Identify, communicate, and manage potential study risks.
- Lead CRO and vendor selection and negotiations.
- Oversee and collaborate with study vendors and consultants.
Required Skills and Qualifications
- Excellent presentation skills with the ability to communicate complex issues clearly.
- Excellent planning and organizational skills with ability to manage competing priorities.
- Excellent oral and written English communication skills.
- Ability to motivate, influence, and collaborate with multidisciplinary teams.
- Ability to work independently and in a global environment.
- Robust understanding of safety business processes and systems for the collections of adverse events.
- Problem-solving, conflict resolution, and critical thinking skills.
- Demonstrated ability to author or contribute to complex documents.
Benefits
- A comprehensive benefits package including medical, dental, and vision insurance.
- A 401(k) retirement plan with company match.
- Paid time off and holidays.
- Professional development opportunities.
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