Sr. Manager, Post Marketing Study

hace 4 meses

Unión Murcia provincia, España Argenx A tiempo completo

(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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