Overview
In this role you support the initiation of clinical trials, ensuring regulatory compliance and alignment with ICON’s mission. You’ll work with cross-functional teams to drive site start-up activities and maintain rigorous documentation. You will tackle regulatory submissions, approvals, and study documents to help bring new therapies to patients faster. You join a values-driven culture that prioritizes integrity, collaboration, and inclusion while handling fast-paced, detail-oriented tasks. This role offers the chance to contribute to global studies and growth in a supportive, learning-focused environment.
Pay / Benefits
- Competitive base salary
- Health and wellbeing programmes
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities
Responsibilities
- Assist in preparing and submitting regulatory documents (clinical trial applications and ethics submissions)
- Coordinate with internal and external stakeholders to obtain approvals for study initiation
- Maintain accurate records of regulatory submissions and approvals
- Support development of study documents (protocols, informed consent forms, investigator brochures)
- Participate in start-up meetings and provide input on regulatory requirements and timelines
Key requirements
- Bachelor in Life Sciences
- Experience in clinical research or regulatory affairs preferred but not required
- Strong attention to detail and organizational skills
- Excellent communication and interpersonal skills for cross-functional collaboration
- Ability to work independently and manage multiple tasks in a fast-paced environment
- Advanced English proficiency (written and spoken)
- communication
- team collaboration
- attention to detail
- regulatory submissions
- clinical trial documentation
- regulatory affairs knowledge
Study Start Up Associate I in Swansea employer: Icon Clinical PLC
At ICON, we pride ourselves on being a values-driven organisation that fosters a collaborative and inclusive work culture. As an Operation Program Specialist, you will not only contribute to meaningful healthcare projects but also benefit from our comprehensive rewards package, including competitive salaries, health programmes, and robust career development opportunities. Join us in Sofia, Warsaw, or Swansea, where your expertise will be valued and your professional growth supported in a dynamic environment dedicated to bringing new treatments to patients faster.
