Clinical Trial Start-Up Lead II

ICON Strategic Solutions; France; On-site; EUR 50,000 - 75,000; Full time

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate II in France to lead site start-up activities supporting global sponsors. You will ensure regulatory compliance, coordinate approvals, and manage start-up documentation to enable timely trial activation.

The role requires 2+ years in clinical research or regulatory affairs with ICH-GCP knowledge and strong cross-functional collaboration. Some travel (~5%) may be required. The company offers competitive salary and benefits packages.

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum 2 years in clinical research or regulatory affairs, with study start-up experience.
• Strong understanding of regulatory requirements for clinical trials (ICH-GCP and local regulations).
• Excellent organizational and project management skills; ability to multitask.
• Excellent communication and collaboration with cross-functional teams; willing to travel ~5%.

Responsibilities

• Lead site start-up and activation activities with deliverables.
• Prepare and submit regulatory documents (CTAs, ethics submissions, regulatory communications).
• Coordinate with internal and external stakeholders to obtain approvals for study initiation.
• Maintain accurate records of regulatory submissions, approvals, and correspondence.
• Provide guidance on regulatory requirements and best practices for study start-up.

Skills

Regulatory affairs

Clinical research

Project management

Communication

Travel readiness

Education

Bachelor's degree in life sciences

Job description

ICON Strategic Solutions is seeking a Study Start Up Associate II in France to lead site start-up activities supporting global sponsors. You will ensure regulatory compliance, coordinate approvals, and manage start-up documentation to enable timely trial activation.

The role requires 2+ years in clinical research or regulatory affairs with ICH-GCP knowledge and strong cross-functional collaboration. Some travel (~5%) may be required. The company offers competitive salary and benefits packages.