NASCR Manager UK

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Project Manager at ICON, you will be responsible for leading and coordinating project activities, ensuring that projects are delivered on time, within budget, and to the highest quality standards.

Key Purpose

Primary point of contact to lead, manage and coordinate the operational implementation of Non-Amgen Sponsored Clinical Research (NASCR) from receipt of submission to close-out, in accordance with global Investigator Sponsored Studies (ISS) and Expanded Access (EA) SOPs and other supporting documentation. NASCR includes Investigator Sponsored Studies (ISS), Research Partner Studies (RPS), and Expanded Access.

Key Activities

• Manage and oversee one or more ISS product portfolios including lead for multi-regional studies
• Lead and operationalize NASCR activities in accordance with global ISS and EA SOPs and other supporting documentation
• Coordinate review and approval of ISS proposals and protocols in collaboration with cross-functional teams and governance bodies
• Liaise with Sponsor and cross-functional team (driving «One Amgen») to facilitate ISS-related activities from proposal receipt through close-out
• Facilitate communication with sponsor, in collaboration with Medical POC, for quality and completeness of end-to-end NASCR process (e.g. provision of scientific comments on protocol, actions arising from Due Diligence, acquisition of documents supporting EA requests)
• Ensure execution of Confidential Disclosure Agreements where necessary
• Complete sponsor qualification process
• Facilitate cross-functional review process for proposals, protocols, and amendments
• Facilitate or support meetings internally (e.g. product-specific Pre-KEG review meetings, EGT, Drug Supply Plan) and with Sponsor as appropriate (creating agendas, minutes, etc)
• Ensure conduct of Fair Market Value assessment for all funded ISS
• Ensure provision of protocol submission and open study packages to sponsor
• Coordinate the contract execution process in collaboration with legal representative
• Facilitate provision and updating of any regulatory cross-reference or quality documents (e.g. sIMPD) provided by Amgen to support Sponsor’s CTA/IND
• Partner with Supply Chain representatives to facilitate the set-up and continuity of IP supply including the processing of temperature excursions and product complaints where required
• Ensure the completion and re-evaluation of ISS Regulatory Assessment (ISSRA) and Initiation Package (ISSIP) documents as required
• Ensure timely tracking, archiving, and reconciliation of essential documentation
• Ensure updates to relevant source systems (e.g. milestone tracking, enrolment status)