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- Tasks: Lead global study start-up activities and ensure timely trial document completion.
- Company: Join ICON, a top healthcare intelligence and clinical research organisation.
- Benefits: Competitive salary, health insurance, flexible benefits, and work-life balance.
- Other info: Remote work available in UK, Spain, Bulgaria, or Poland with excellent career growth.
- Why this job: Shape the future of clinical development in a diverse and inclusive environment.
- Qualifications: Experience in clinical research or pharmaceutical industry; leadership skills required.
The predicted salary is between 60000 - 80000 £ per year.
SSULICON 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.
Location: UK, Spain, Bulgaria or Poland (Remote)
Working fully embedded within a growing, top 5 Pharmaceutical company, you will be responsible 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.
You are:
- Must have right to work in any of these countries - UK, Spain, Poland or Bulgaria.
- Must have relevant experience in a similar role, ideally within a senior SSU role.
- Must have experience working within either the Clinical Research, Biotech or Pharmaceutical industry.
- Be able to start a new role in May 2026 (highly advantageous).
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.
- 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, 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.
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 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.
Study Start-Up Lead employer: IRE
Contact Detail:
IRE Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Study Start-Up Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research and pharmaceutical industries. A friendly chat can lead to insider info about job openings or even a referral, which can give you a leg up in the application process.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their mission and values, especially around inclusivity and innovation. This will help you tailor your responses and show that you're genuinely interested in being part of their team.
✨Tip Number 3
Practice common interview questions related to study start-up roles. Think about your past experiences and how they align with the responsibilities listed in the job description. We want you to feel confident and ready to showcase your skills!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining us at ICON and contributing to our mission in clinical development.
We think you need these skills to ace Study Start-Up Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Study Start-Up Lead role. Highlight relevant experience in clinical research, biotech, or pharmaceuticals, and showcase your leadership skills in SSU activities.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your background aligns with our mission at ICON. Keep it concise but impactful!
Showcase Your Achievements: Don’t just list your responsibilities; highlight your achievements in previous roles. Use specific examples that demonstrate your ability to lead teams and manage timelines effectively.
Apply Through Our Website: We encourage you to apply directly through our careers site. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity!
How to prepare for a job interview at IRE
✨Know Your Stuff
Make sure you understand the key responsibilities of a Study Start-Up Lead. Familiarise yourself with terms like eTMF, CTMS, and ICF. Being able to discuss these concepts confidently will show that you're serious about the role.
✨Show Your Leadership Skills
Since this role involves leading teams, be prepared to share examples of how you've successfully led projects or teams in the past. Highlight your ability to manage timelines and ensure document readiness, as these are crucial for the position.
✨Ask Smart Questions
Prepare thoughtful questions about the company's approach to clinical trials and their expectations for the SSU team. This not only shows your interest but also helps you gauge if the company culture aligns with your values.
✨Be Ready for Scenario-Based Questions
Expect to face scenario-based questions that assess your problem-solving skills. Think about challenges you've faced in previous roles and how you overcame them, especially in relation to trial document management and vendor coordination.