Senior Study Start-Up Associate

ICON plc

Assen, Drenthe, Netherlands

Remote

Expert

Starts as soon as possible

posted 3 days ago

Vacancy Summary

Join ICON Strategic Solutions as a Senior Study Start-Up Associate, where you'll leverage your expertise in clinical trial submissions to support the development of new treatments. Enjoy a collaborative environment and career growth opportunities within the world's largest FSP organization.

Required skills

Contract Negotiation

communication

Coordination

Learning and Development

Accessibility

Regulatory Compliance

Teams

Distribution

safeguarding

Stability

English

Assurance

Clinical Trials

Support

FSP

Patient Safety

Partnerships

Vision

Recruitment Process

Science

regulations

Health

Legal

Training

Management

Total Rewards

Performance

Bachelor's Degree

Site Start-Up

wellbeing

Forms

Welfare

understanding

Benefits

Career Development

Standards

Discipline

Assistance

Conduct

LEAD

Clinical Trial Submissions

Feasibility Assessments

English level

Fluent

Languages

Dutch

English

SSU Support At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organization, with over 90 sponsor partnerships, we offer stability, career development, and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide. As a Senior Study Start-Up Associate at ICON, you will be working within a large-scale, fast-paced environment, supporting the Study Start-Up Team Lead in developing and executing the plan for country and site distribution in the Netherlands. We are looking for candidates with experience in Clinical Trial Submissions for the Netherlands to acquire approval from Health Authorities and via the CTIS application to start-up new assigned clinical trials.

Responsibilities:

  • Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities.
  • Empower Success through Specialized SSU Expertise: Provide expertise to Study Start-Up team leads and project teams, providing valuable insights to drive success.
  • Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines.
  • Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent.

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