đ Drive Trial Activation: Site & Study Start-Up (SSU) Specialist
Join ICON plc, a world-leading healthcare intelligence and clinical research organization, as a Site & Study Start-Up (SSU) Specialist. This is your opportunity to be the operational catalyst for clinical trial activation, ensuring investigative sites are identified, qualified, and initiated with speed and compliance to accelerate the development of life-changing therapies.
We are seeking an experienced start-up professional to manage the critical pre-activation phase. If you excel at navigating regulatory pathways, building site relationships, and optimizing processes to reduce timelines, this role is your chance to significantly impact clinical research from the ground up.
đŻ Your Site & SSU Mission: Key Responsibilities
Site Identification & Feasibility Leadership
- Lead end-to-end site identification and feasibility processes to build a high-performing site portfolio for clinical trials.
- Develop and distribute feasibility questionnaires, analyze site responses, and make data-driven recommendations for site selection.
- Conduct pre-study site visits (PSVs) or remote qualification assessments to evaluate site capability, experience, and readiness.
Regulatory & Ethical Submission Management
- Lead the preparation, compilation, and submission of all essential regulatory, ethics committee (EC), and other local authority documents for site activation.
- Serve as the primary liaison with investigative sites to collect, review, and ensure the accuracy and completeness of all necessary start-up documents.
- Track and manage all submissions, approvals, and approvals until the green light for site initiation is received.
Contract & Budget Negotiation Support
- Facilitate the development and negotiation of clinical trial agreements (CTAs) and site budgets in collaboration with legal and finance teams.
- Coordinate the execution of finalized contracts and ensure financial documentation is in place prior to site activation.
Process Optimization & Timeline Acceleration
- Actively identify and implement process improvements to streamline the start-up lifecycle and reduce activation timelines.
- Utilize start-up tracking systems to provide transparent updates on site activation milestones and proactively mitigate risks or delays.
Cross-Functional Collaboration & Expertise
- Act as the key SSU point of contact for investigative sites, Clinical Research Associates (CRAs), and internal project teams.
- Provide expert guidance on local regulatory requirements, submission strategies, and start-up best practices to ensure global compliance.
â Your Profile: SSU Specialist Expertise
Essential Qualifications
- Bachelorâs degree in Life Sciences, Regulatory Affairs, or a related field.
- Minimum of 2 years of direct experience in clinical research with a dedicated focus on study start-up and site activation activities.
- Proven track record in preparing and submitting regulatory/ethics packages and managing approvals.
- Strong understanding of ICH-GCP guidelines and country-specific regulatory landscapes.
Core Competencies
- Project Management Excellence:Â Superior organizational skills with the ability to prioritize and drive multiple site activations simultaneously.
- Stakeholder Engagement:Â Excellent communication and interpersonal skills to build trust and collaborate effectively with sites and internal teams.
- Detail-Oriented Execution:Â Meticulous attention to detail in document preparation, tracking, and compliance adherence.
- Problem-Solving Agility:Â Ability to anticipate hurdles, develop solutions, and keep activation timelines on track.
Valued Experience
- Hands-on experience with clinical trial agreements (CTAs) and budget negotiations.
- Proficiency using clinical trial management systems (CTMS) and start-up tracking tools.
- Experience across multiple therapeutic areas and study phases.
đŤ Why Build Your SSU Career at ICON?
Direct Impact on Clinical Timelines
- Play the central role in transitioning studies from protocol to active recruitment, directly accelerating patient access to new treatments.
- Your expertise ensures compliant and efficient site activation, a critical factor in overall trial success.
Career Advancement & Growth
- Clear pathway to senior SSU and leadership roles within one of the worldâs largest CROs.
- Gain unparalleled exposure to diverse regulatory environments and complex study designs.
- Develop a highly specialized, in-demand skill set at the heart of clinical operations.
Work in a Collaborative Global Network
- Be part of a dedicated, global SSU community that shares best practices and fosters professional support.
- Collaborate with industry-leading experts in regulatory, clinical, and project management.
Competitive ICON Benefits
- Attractive salary and performance-based incentives.
- Comprehensive health, dental, and vision insurance for you and your family.
- Generous paid time off and flexible working arrangements.
- Robust retirement savings plan with company match.
- Global Employee Assistance Programme and well-being initiatives.
- Continuous investment in your professional development through training and career mentoring.
â¨Â Ready to Activate Sites and Accelerate Clinical Research?
If you are a proactive, results-driven professional passionate about building the foundation for successful clinical trials, we encourage you to apply. This Site & SSU Specialist role is your opportunity to own the start-up process and become a key driver of efficiency in global drug development.
Apply Now and become the specialist who turns investigative sites into active partners in pioneering clinical research.
