Study Start-Up Lead

Job title:Study Start Up Lead

Location: UK, Spain, Poland, Bulgaria, Netherlands (fully homebased)

Fully sponsor dedicated

As a Study Start Up Manager, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Working fully embedded within a growing, top 5 Pharmaceutical company, you will be responsbile for executing global SSU activities to ensure timely trial document and task completion to enable country HA (Health Authorities) and Ethics Committee submissions and site activation to meet ambitious recruitment plans.

What you will be doing:

Early Planning and Team Leadership:

• Contributes SSU insights to the development of the trial Operational Execution Plan (OEP) and aligns the SSU plan and strategy accordingly as reflected in SSU systems, milestones and dashboards with Study Leader/Clinical Trial Team (CTT).
• Configures and ensures proper trial-specific set-up of SSU systems (e.g., Expected Document Lists, eTMF, milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.)
• Prepares global SSU planning and leads SSU Team (CTT sub-team) from kick-off through completion of SSU (all countries and 95% sites enrolling or as defined per trial)

Leads Global SSU Activation: 

• Ensures timely collection global trial level document readiness (including vendor and IMP (INVESTIGATIONAL MEDICINAL PRODUCT)) and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation.
• Supports the Vendor Program Manager (VPM) as needed to ensure timely global vendor activation and HA submission documents.
• Ensures Protocol and ICF (Informed Consent Form) global trial template is ready for country usage as necessary including translations.
• Directs the Study Grants Expert for investigator grant plan/fair market value assessment initiation and finalization of country site budget and contract template readiness in conjunction with protocol timelines Global accountability of timelines, accuracy, and quality of global TMF (Trial Master File) documents in study start-up to ensure TMF inspection readiness.
• Provide proactive oversight and risk management for SSU team activities to achieve start-up timelines and quality execution, proposing and implementing corrective actions where appropriate, according to our clients standards and local and international regulations.
• Collaborates with GCS (Global Clinical Supply) to ensure coordination and readiness of global clinical supply.

1. Enables country Study Start-up Managers to drive timely start-up activities from country allocation to “Ready to Enroll” within assigned trial.
2. Provides oversight and support to country Study Start-up Managers as needed to ensure that study start-up activities are conducted and completed to plan, including set-up and usage of tools/systems, timely delivery of SSU deliverables (e.g. IRB/IEC submission packages, Informed Consent review, local submission package for submission to IRB/IEC, CTA (Clinical Trial Application) Hub (Europe: acc. to new EU-CTR) as well as Health Authorities and adherence to process standards.
3. Supports the VPM as needed to ensure global vendor activation and site readiness in collaboration with to meet site activation timelines/plan.
4. Ensure global deliverables to enable site initiation readiness is in place for initial drug release.
5. Ensures global and country budget (TCF (Trial Commitment Forms)) processes and approvals support SSU activities and timelines.

You are:

• Must have right to work in any of these countries - UK, Spain, Poland, Bulgaria or Netherlands (fully homebased)
• Must have relevant experience in a similar role, ideally within a senior SSU role
• Must have experience working within either the Clinical Research or Pharmaceutical industry

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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, colour, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

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.