Sr. Manager, Post Marketing Study

☞ Argenx

View: 105

Update day: 04-11-2025

Location: Ghent East Flanders

Category: Executive management Marketing / PR

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Accountable for the operational activities including the planning, conducting, and completing argenx 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.
ROLES AND RESPONSIBILITIES:
  • Drive the conduct of the PMRs 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 PMRs.
  • 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.
  • Collaborate closely with other departments including e.g. 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 e.g. 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.
  • May perform other tasks as assigned by GPS leadership.
SKILLS AND COMPETENCIES:
  • 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 e.g. project plans, protocols, study reports, or regulatory submissions.
  • Advanced computer skills, including data collections systems and proficiency with Microsoft Office Suite
  • Fluency in written and spoken English
EDUCATION, EXPERIENCE AND QUALIFICATIONS:
  • Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field
  • At least 5 -7 years of experience in the pharmaceutical/biotech industry
  • At least 3 years of experience in clinical operations, post-authorization studies and other post-marketing pharmacovigilance requirements
  • Demonstrated project management skills
  • Demonstrated experience with planning and managing study operations
  • Ability to manage CROs or other clinical service providers
  • Working knowledge of pharmacovigilance regulatory requirements worldwide
  • Expert knowledge of the drug development process, GXP quality and compliance requirements
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Deadline: 19-12-2025

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