Sr. Manager, Post Marketing Study

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