Homeoffice Sr. Manager, Post Marketing Study with verification

(Sr) Manager Post-Marketing Requirement Studies (PMR)

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.

Role 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