Study Delivery Specialist

Study Delivery Specialist - Remote

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.

We are currently seeking a Study Delivery Specialist (Global Project Associate/Analyst) to join our diverse and dynamic team.

We are looking for candidates who have experience in global study management working in such roles as Global CTAs, Clinical Trial Coordinator, Project Specialist/Coordinator.  In our role you will work remotely and be part of the sponsor's global study team. 

Responsibilities & Tasks:

• In this role you will be a key member of the sponsor's Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completenes

• Responsible for budget oversight – managing Task/Change Orders, expenses, tracking updates, checking consistency between systems and agreements and escalating issues to the Project Manager

• Responsible for overseeing delivery of clinical supplies, investigational products and all study materials provided by the sponsor or external service providers

• You will be responsible for country oversight, acting as a primary point of contact, tracking of recruitment progress, data completeness and compliance, overseeing local budgets, protocol deviations, risks, regulatory approvals and import license status

• Vendor management and CRO oversight, acting as a primary point of contact, overseeing study-specific deliverables, ensuring continued monitoring and timely delivery of activities delegated to third parties.

• Data oversight, including oversight of eTMF completeness (eTMF setup, periodic reviews, following up on missing documents, Safety Reports Dissemination), and assure that all eTMF documents are complete and verified for quality.

• Maintaining interactions and meetings with internal and external partners

• Responsible for reviewing key clinical documents, including the Protocol and Informed Consent Forms, and leading development of study plans (e.g. Monitoring Plan, Vendor Management Plan, Protocol Deviation Management Plan, Risk Management Plan,Communication Plan etc.) for external and internal use in assigned studies.

• Monitoring study conduct and progress, identifying, resolving and escalating risks/issues 

• You will be responsible for setting up and maintaining systems and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed. Granting access to new system users.

• This is a fully remote role and you will be responsible to perform activities for one or several global projects (2-3).

• You will work in collaboration with the Global Clinical Project Managers to provide end to end operational and administrative support for study delivery activities in your assigned trials.

Your Profile:

• Graduate or Bachelor level with at least 1.5+ years of clinical trial experience

• Previous global study management in clinical research is required for this role - we are looking for candidates with experience as a Project Associate/Analyst or Project Coordinator who support Project Managers at study level

• Global administrative experience working with eTMF and CTMS

• Fluent English

• Good understanding of the principles of project planning & project management in clinical research

• Scientific background and knowledge of clinical trials (including ICH-GCP) is required.

• Ability to manage multiple competing priorities within various clinical trials with good planning, time management and prioritization skills

• Familiarity with basic finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports

• Tools knowledge like Microsoft office (Excel, PowerPoint, Word, Outlook, etc.)

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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.

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