Study Start-Up Lead – Clinical Trials

ICON Strategic Solutions; Sweden; On-site; SEK 600,000 - 800,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee assistance program

Life assurance

Country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Study Start Up Associate II to join our sponsor-dedicated model, supported by ICON’s global expertise. You will lead initiation of clinical trials in line with regulatory requirements, contributing to the advancement of innovative treatments.

You will manage site start-up activities, coordinate with stakeholders, ensure regulatory submissions are accurate, and drive process improvements for faster activation of trials worldwide.

Qualifications

• Bachelor's degree in life sciences or related field.
• Minimum of 2 years in clinical research or regulatory affairs with study start-up experience.
• Solid understanding of ICH-GCP and local regulatory requirements.
• Strong organizational and multitasking abilities.
• Excellent communication and interpersonal skills.

Responsibilities

• Lead the preparation and submission of regulatory documents and ethics submissions.
• Coordinate with internal and external stakeholders to obtain approvals for study initiation.
• Maintain comprehensive records of submissions and correspondence.
• Provide guidance on regulatory requirements to study teams.
• Participate in process improvements to streamline study start-up activities.

Skills

Regulatory knowledge

Project management

Communication

Cross-functional collaboration

Travel readiness

Education

Bachelor's degree in life sciences

Job description

ICON Strategic Solutions is seeking a Study Start Up Associate II to join our sponsor-dedicated model, supported by ICON’s global expertise. You will lead initiation of clinical trials in line with regulatory requirements, contributing to the advancement of innovative treatments.

You will manage site start-up activities, coordinate with stakeholders, ensure regulatory submissions are accurate, and drive process improvements for faster activation of trials worldwide.