All roles

Open role

Study Start up Associate II

Remote · Japan Full-time

Study Start Up Associate 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. As a Study Start Up Associate II at ICON, you will lead the initiation of clinical trials, ensuring compliance with regulatory requirements, and contribute to the advancement of innovative treatments and therapies. What You Will Do: You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively. Key responsibilities include: Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications. Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation. Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities. Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency. Your Profile: You will bring relevant site start-up and activation experience, along with the following qualifications and skills. Required qualifications and experience: Bachelor's degree in life sciences or a related field. Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities. Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements. Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Willingness to travel as required (approximately 5%) 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

More open positions

Senior Principal Engineer

Work from home Full-time role

Sr Performance Engineer

Work from home Full-time role

Senior Modelling Engineer (m/w/d)

Work from home Full-time role

SIOP Coordinator (m/f/d) – HVAC Europe

Work from home Full-time role

GDX Elevated Support Manager, International

Work from home Full-time role

Territory Business Manager (Addiction) – North Carolina West

Work from home Full-time role

Technical Support Manager - West Coast/Pacific Time Zone

Work from home Full-time role

Work from Home Insurance agent

Work from home Full-time role

Experienced Remote Customer Service Representative – Texas-Based, Pet Industry E-Commerce Support & Technical Problem Resolution Expert

Work from home Full-time role

Medical Science Liaison - Hematology/Oncology - NY

Work from home Full-time role

Broadband Specialist

Work from home Full-time role

[Remote] Staff Software Engineer, GitHub Actions

Work from home Full-time role

Junior UI/UX Designer (Remote Opportunity)

Work from home Full-time role

Home-Based Experienced CRA; Clinical Research Associate​/Equity

Work from home Full-time role

[Remote] Customer Service Representative

Work from home Full-time role

Experienced Customer Care Professional – Data Entry & Client Support Specialist (Remote)

Work from home Full-time role

Group Managing Lawyer, Helix

Work from home Full-time role

Remote Chief Staff Officer

Work from home Full-time role

Senior Software Engineer, Windows/Desktop Applications - Virginia Beach, VA, USA

Work from home Full-time role

Director, SMA Model Specialist

Work from home Full-time role

Entry-Level Online Chat Support Specialist – Customer Experience & Communication Excellence at careerzynith (UAE)

Work from home Full-time role