Senior Manager, Post-Marketing Research

hace 3 días

Murcia, Murcia, España Argenx A tiempo completo
Job Title: Senior Manager, Post-Marketing Study

As a Senior Manager, Post-Marketing Study at Argenx, you will be responsible for leading the operational activities of post-marketing studies globally (excluding Japan) in compliance with regulatory requirements. Your key responsibilities will include planning, coordinating, and managing the selection and operations of CROs and other study vendors.

Key Responsibilities:
  • Drive the conduct of post-marketing studies or other non-interventional safety studies, ensuring that study milestones are met (including site selection, enrolment targets, interim reports) in accordance with protocols and regulatory requirements.
  • Manage and actively contribute to project planning and budgeting as related to post-marketing studies.
  • Maintain adequate trackers, metrics, and progress reports regarding budget, timelines, deliverables, and documentation.
  • Ensure timely collection, documentation, and reporting of Adverse events (AEs) and Serious AEs (SAEs) in collaboration with GPS Operations.
  • Identify, communicate, and manage potential study risks regarding study start-up, conduct, data management, analysis, and monitoring.
  • Lead CRO and vendor selection and negotiations in collaboration with Argenx vendor management.
  • Oversee and actively collaborate with study vendors and consultants.
  • Closely collaborate with other departments including Quality, Medical Affairs, Regulatory, Finance, and Legal on issues and potential solutions.
  • Oversee and/or contribute to the development and maintenance of study documents including ICFs, protocols, adverse event reporting forms, as well as SOPs or other procedural documents.
  • Support the preparation of publications as needed.
  • Actively participate in site or vendor audits and inspections.
  • Transparently communicate and/or escalate issues to GPS leadership as needed.
  • Promote and implement innovative processes and continuous improvement initiatives as needed.
Requirements:
  • 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 collection of adverse events.
  • Problem-solving, conflict resolution, and critical thinking skills.
  • Demonstrated ability to author or contribute to complex documents such as project plans, protocols, study reports, or regulatory submissions.

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