🚀 Accelerate Clinical Innovation: Study Start-Up Associate II (SSUA)
Join ICON plc as a Study Start-Up Associate II and become the driving force behind rapid clinical trial activation. This pivotal role positions you as the regulatory expert who navigates approval pathways, ensuring compliant and efficient study initiation for groundbreaking medical research worldwide.
As a world-leading healthcare intelligence organization, we're seeking an experienced start-up specialist to lead regulatory submissions and site activation processes. If you're passionate about regulatory excellence and thrive on bringing innovative studies to life, this is your opportunity to advance your career while accelerating the development of life-changing treatments.
🎯 Your Study Start-Up Mission: Key Responsibilities
Regulatory Submission Leadership
- Lead preparation and submission of comprehensive regulatory documents including clinical trial applications and ethics committee submissions
- Manage regulatory agency communications and ensure timely responses to queries
- Maintain meticulous records of all regulatory submissions, approvals, and correspondence
- Ensure 100% compliance with ICH-GCP guidelines and local regulatory requirements
Stakeholder Coordination & Approval Management
- Coordinate with internal and external stakeholders to obtain essential approvals and authorizations
- Serve as primary liaison between study teams, regulatory authorities, and ethics committees
- Facilitate effective communication channels for smooth study initiation processes
- Manage approval timelines and proactively address potential delays
Process Optimization & Efficiency
- Participate in process improvement initiatives to streamline study start-up workflows
- Implement best practices for document management and submission tracking
- Contribute to development of standardized start-up tools and templates
- Identify opportunities to reduce start-up timelines while maintaining compliance excellence
Team Guidance & Support
- Provide expert guidance to study teams on regulatory requirements and start-up best practices
- Support training initiatives for new team members on start-up processes
- Share knowledge and insights to enhance team capabilities and efficiency
- Collaborate effectively with cross-functional teams including clinical operations and regulatory affairs
Quality Assurance & Documentation
- Ensure comprehensive documentation meets audit readiness standards
- Maintain organized regulatory files and tracking systems
- Conduct quality checks on submission packages before regulatory filing
- Support inspection readiness through meticulous record-keeping
⭐ Your Profile: Study Start-Up Expertise
Essential Qualifications
- Bachelor's degree in Life Sciences, Regulatory Affairs, or related field
- Minimum 2 years experience in clinical research or regulatory affairs with focus on study start-up
- Strong understanding of ICH-GCP guidelines and global regulatory requirements
- Experience with clinical trial application submissions and ethics committee processes
Regulatory Competencies
- Knowledge of regulatory submission pathways and approval processes
- Familiarity with clinical trial documentation requirements
- Understanding of ethics committee operations and requirements
- Experience with regulatory agency interactions and communications
Professional Attributes
- Excellent Organizational Skills: Ability to prioritize and manage multiple tasks simultaneously
- Strong Project Management: Capability to coordinate complex start-up timelines
- Exceptional Communication: Effective collaboration with cross-functional teams
- Attention to Detail: Meticulous approach to regulatory documentation and compliance
Start-Up Specialization
- Experience across multiple study phases and therapeutic areas
- Understanding of site activation requirements and timelines
- Knowledge of country-specific regulatory landscapes
- Ability to navigate complex approval pathways efficiently
💫 Why Build Your Start-Up Career at ICON?
Impact Clinical Trial Timelines
- Play crucial role in accelerating study initiation and site activation
- Contribute to faster patient access to innovative treatments
- Ensure regulatory compliance from study inception
- Support ICON's mission of advancing clinical development efficiently
Career Growth & Specialization
- Clear pathway to Senior Start-Up Associate and Regulatory Leadership roles
- Exposure to diverse therapeutic areas and global regulatory environments
- Opportunities for specialization in specific regions or therapeutic areas
- Professional development in growing clinical start-up field
Collaborative Excellence
- Work with experienced regulatory and clinical operations professionals
- Access to global start-up networks and best practices
- Participate in strategic initiatives that shape study activation approaches
- Supportive team environment with knowledge sharing culture
Competitive ICON Benefits
- Attractive salary package with performance incentives
- Comprehensive health insurance for you and your family
- Global Employee Assistance Programme with 24/7 support
- Generous annual leave entitlements and flexible scheduling
- Retirement planning benefits and financial security
- Professional development allowance and training opportunities
- Modern work environment with collaborative culture
📋 Regulatory Areas You'll Master
- Clinical Trial Application Submissions
- Ethics Committee Approval Processes
- Regulatory Agency Communications
- Site Activation Documentation
- Inspection Readiness Preparation
⏱️ Timelines You'll Accelerate
- Regulatory Approval Timelines
- Ethics Committee Review Periods
- Site Activation Schedules
- Document Collection & Verification
- Study Initiation Readiness
🌍 Global Exposure
- Diverse Regulatory Landscapes
- International Ethics Requirements
- Cross-Cultural Stakeholder Management
- Global Best Practices Implementation
- International Compliance Standards
✨ Ready to Launch Groundbreaking Studies?
If you're an experienced study start-up professional with regulatory expertise and passion for accelerating clinical research, we encourage you to apply. This Study Start-Up Associate II role offers the unique opportunity to advance your career while ensuring efficient and compliant initiation of clinical trials that transform patient care worldwide.
Apply Now and become ICON's next Study Start-Up Acceleration expert!
