Study Start Up Associate II

• Study Start-Up Specialist (Sponsor Dedicated)
• ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• •Competitive base salary and performance related incentives
• •Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• •Retirement and pension plans
• •Life assurance and disability coverage
• •Employee assistance programmes and wellbeing resources
• •Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here .

Are you a current ICON Employee? Please click here to apply