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Senior Study Start Up Associate

ICON plc

Assen, Utrecht
Full-time
2-5 years experience
Remote OK

Key Skills

Clinical trial submissions
Feasibility assessments
Site identification
Site contract negotiation
Regulatory compliance
Patient safety
Informed consent
Study start-up
Project management
Communication
Collaboration
Regulatory coordination

Job Description

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 organisation, 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 execute 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.


What You Will Do:


You will lead on site start-up and activation tasks requiring technical depth, with a focus on quality and continuous improvement.


Key responsibilities include:


  • 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.



Your Profile:


You will have a strong foundation in site start-up and activation, with the experience to work independently and guide others.


Required qualifications and experience:


  • A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.
  • At least 3 years of experience or understanding of clinical study start-up requirements and activities, showing your expertise in the field.
  • Fluency in the local language and English is essential, enabling you to effectively communicate and collaborate with international teams.
  • Willingness to travel as required (approximately 5%)

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.


Are you a current ICON Employee? Please click here to apply

Core Responsibilities

You will lead site start-up and activation tasks, including feasibility assessments, site identification, and contract negotiations. Additionally, you will coordinate regulatory submissions and ensure the highest standards of patient safety and informed consent.

Requirements

Candidates must hold a Bachelor's degree or equivalent in a medical or science field. At least 3 years of experience in clinical study start-up requirements and fluency in English and the local language are required.

Benefits

  • Competitive base salary
  • Performance related incentives
  • Medical coverage
  • Dental coverage
  • Vision coverage
  • Retirement plans
  • Pension plans
  • Life assurance
  • Disability coverage
  • Employee assistance programmes
  • Wellbeing resources
  • Learning and development opportunities

About ICON plc

Industry: Biotechnology Research

Company size: 10,001+ employees

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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