Study Start-Up Lead: Regulatory & Submissions

ICON Clinical Research; France; Remote; EUR 42,000 - 63,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Life assurance

Global EAP LifeWorks

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate II to drive site start-up and activation for clinical trials in collaboration with global teams. You will lead regulatory document preparation, ethics submissions, and ensure compliant study initiation.

Responsibilities include coordinating with sponsors, sites, and internal stakeholders, maintaining regulatory records, and supporting process improvements to streamline study start-up timelines. Travel up to 5% may be required.

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum 2 years in clinical research or regulatory affairs, with start-up experience.
• Knowledge of regulatory requirements for clinical trials (ICH-GCP, local rules).
• Strong organizational and multitasking abilities.
• Excellent communication and collaboration skills.
• Willingness to travel approximately 5%.

Responsibilities

• Lead site start-up and activation activities and deliverables.
• Prepare and submit regulatory documents including CTAs, ethics submissions, and agency communications.
• Coordinate approvals with internal and external stakeholders for study initiation.
• Maintain comprehensive records of regulatory submissions and correspondence.
• Provide guidance on regulatory requirements and best practices for start-up activities.
• Participate in process improvement to streamline start-up timelines.

Skills

Study start-up

Regulatory affairs

ICH-GCP

Project management

Cross-functional collaboration

Travel availability

Education

Bachelor's degree in life sciences

Job description

ICON Strategic Solutions is seeking a Study Start Up Associate II to drive site start-up and activation for clinical trials in collaboration with global teams. You will lead regulatory document preparation, ethics submissions, and ensure compliant study initiation.

Responsibilities include coordinating with sponsors, sites, and internal stakeholders, maintaining regulatory records, and supporting process improvements to streamline study start-up timelines. Travel up to 5% may be required.