Support the planning, decision-making, and implementation of Individual Post-trial Access to Investigational Product (IPTA2IP) and facilitate the continued provision of investigational products to eligible clinical trial participants who have derive clinical benefit during a clinical trial after trial completion in accordance with Sanofi’s Policy Position on Post-trial Access to Investigational Products.
The Post-Trial Access (PTA) Coordinator primary role is to work closely with and support the PTA Lead in coordinating all funded PTA requests and maintain the tracking of these requests through the review process and until the decision is communicated to the requesting physician.
The PTA coordinator responsibilities :
Request PTA Code
Organize PTA strategy meetings, kick off and oversight meetings with all stakeholders
Request PO Setup
Request set up in relevant tools Physician portal, PV Database)
Customize forms as needed
Assure relevant budget / timeline information is shared with appropriate internal stakeholders (eg, Clinical Trial Finance (CTF) and Operational Planning & Capacity Manager (OPCM))
Support the tracking of PTA budget and spend
Documentation Management, incl. vendor file transfer, review & reconciliation, and archiving & retention
Assure portal updates
Tracking launch / approval dates per product
Assure appropriate stakeholders (CSUs, Global / local medical etc.) are notified of PTA plans
Liaise with MAP coordinators
Compliance with applicable laws and regulations, as well as Sanofi policies, processes and procedures
The PTA coordinator’s main role is to support PTA requests however is also expected to serve as back-up to the MAP coordinators for Managed Access requests, which covers all locally defined pre-approval access mechanisms and programs such as :
Compassionate Use (CU) Cohort
Named Patient Requests
KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS
Knowledge and Skills :
Desired / Preferred Skills & Qualifications :
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