Clinical Trials Start-Up Lead II

KCR Placement; Paris; Hybrid; EUR 42,000 - 62,000; Full time

Benefits offered by this job

Annual leave

Health insurance options

Retirement planning options

Employee assistance programme

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate II to lead site start-up and activation activities for clinical trials in Paris, France. You will coordinate regulatory submissions, ethics approvals, and stakeholder communications while ensuring compliant study initiation.

The role requires 2+ years in clinical research or regulatory affairs, strong organizational skills, and the ability to collaborate across teams.

Qualifications

• Bachelor's degree in life sciences or 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%)

Responsibilities

• You will contribute to site start-up and activation activities, taking responsibility for deliverables and working collaboratively.
• Leading the preparation and submission of regulatory documents, including CTAs, ethics submissions, and regulatory communications.
• Coordinating with internal and external stakeholders to obtain approvals for study initiation.
• Maintaining comprehensive records of regulatory submissions, approvals, and correspondence.
• Providing guidance on regulatory requirements and best practices for study start-up activities.
• Participating in process improvement to streamline start-up processes and efficiency.

Skills

Regulatory knowledge

Start-up process

Project management

Cross-functional collaboration

Travel readiness

Education

Bachelor's degree in life sciences or related field

Job description

ICON Strategic Solutions is seeking a Study Start Up Associate II to lead site start-up and activation activities for clinical trials in Paris, France. You will coordinate regulatory submissions, ethics approvals, and stakeholder communications while ensuring compliant study initiation.

The role requires 2+ years in clinical research or regulatory affairs, strong organizational skills, and the ability to collaborate across teams.