Project Manager

NASCR Manager UK

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values\-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Project Manager at ICON, you will be responsible for leading and coordinate 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 source systems (e.g. milestone tracking, enrolment status)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards \& Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives


• Health and wellbeing programmes including medical, dental, and vision coverage where applicable


• Retirement and pension plans


• Life assurance and disability coverage


• Employee assistance programmes and wellbeing resources


• Learning and development opportunities through structured training and career pathways

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request .

Are you a current ICON Employee?

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