About the job

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 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)

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
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Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply