(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
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