Study Start Up Specialist

Study Start-up Specialist

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.

What you will be doing

• Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.  This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives

•  Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools

•  Proactively identify and escalate issues that arise related to support SSU deliverables 

•  Effectively execute against assigned activities within SSU 

•  Support implementation of standards for global SSU team

•  This may include:

•  Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements

• Implementation of the SSU Strategy for assigned region during the study start up period

• Building relationships with internal counterparts and site staff to support successful site activation strategies

• Projecting site activation timelines and appropriately escalating when things get off track

• Adhering to process and tools designed to the support of the SSU team with day-to-day activities

• Leading the preparation of study level essential document templates

• Aiding in the preparation of content for Regulatory submissions

• Handling ICF negotiations and facilitating any required escalations

• Preparation and submission of IMP Release Packages

• Maintaining accurate and timely information in relevant clinical systems

• Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials. This position has no direct reports but may provide guidance/oversight to contract staff.

Your profile

• BS/BA degree or Associates degree with ≥2 years of experience in clinical trial related start-up experience.

• ICF negotiation experience

•  Must have knowledge of clinical trial conduct

•  General knowledge of drug development and ICH/GCP guidelines

•  Requires proven project management skills

•  Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

•  Fluent in English.

•  Minimal (0-5%) travel required

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