Study Start Up Associate II

ICON plc

Study Start-Up Associate II leading regulatory submissions and site activation for ICON, a global clinical research organisation. Coordinating approvals to help deliver new medicines faster.

Posted 8/5/2026full-timeRemote • 🇩🇪 GermanyJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial initiation and regulatory submissions, with a strong understanding of ICH-GCP and local regulatory requirements. Proven ability to manage project timelines, collaborate with stakeholders, and enhance study start-up processes.

Highest-signal resume keywords

Clinical Trial InitiationRegulatory SubmissionsStudy Start-Up ActivitiesProject ManagementCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ApplicationsRegulatory Document PreparationSite Start-Up ExperienceRegulatory AffairsICH-GCP Guidelines

Soft Skills

Organizational SkillsInterpersonal SkillsCollaborationPrioritizationEfficiency Improvement

Industry Keywords

Clinical ResearchRegulatory RequirementsStakeholder CoordinationProcess ImprovementStudy Activation

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the initiation of clinical trials and contribute to site start-up and activation activities
Prepare and submit regulatory documents, including clinical trial applications and ethics committee submissions
Communicate with regulatory agencies
Coordinate and liaise with internal and external stakeholders to obtain approvals and authorizations for study initiation
Manage and maintain accurate records of regulatory submissions, approvals, and correspondence
Provide guidance and support to study teams on regulatory requirements and study start-up best practices
Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency

Requirements

What you’ll need

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
Relevant site start-up and activation experience
Strong understanding of clinical-trial regulatory requirements and guidelines, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills
Ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills
Ability to collaborate effectively with cross-functional teams
Willingness to travel as required, approximately 5%
Legal right to work in the country where the role is based

Benefits

Comp & perks

Competitive base salary
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
Reasonable accommodations during the recruitment process
Inclusive and accessible workplace