For one of our external clients, we are looking for a Study Start-up Specialist who is a Dutch native speaker. Within this international CRO, they work every day to improve the world's health. Every clinical development solution they provide is underpinned by something special – a deep conviction in what they do. Are you their newest colleague in the start-up phase?

The office location is in Amsterdam (The Netherlands).

As a Study Start-Up Specialist, you act as the direct point of contact with assigned sites, you are specializing in Pre SIV activities, you will be assigned & accountable for managing and driving the strategy for the Pre SIV / start-up tasks of the study (from site identification through pre-initiation). Next to this, you can also support protocol amendments if applicable.

This may include various tasks and roles, contingent upon project phase and country demands, and complexity of the study. 

• Build relationships with investigators and site staff.
• Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:
  • Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
  • Conduct remote Qualification Visits (QVs).
• Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
• Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
• Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
• Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
• Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
• Forecast, develop, manage, and revise plans and strategies for:
  • IRB/IEC and MoH / RA submission/approval,
  • Site activation,
  • Patient recruitment & retention.
• Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
• Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
• Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
• Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
• Work in a self-driven capacity, with limited need for oversight.
• Proactively keep manager informed about work progress and any issues.

• Previous relevant work experience preferred.
• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
• Able to work independently, seeking/taking guidance when necessary.
• Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s).
• Developing ability for effective time management in order to meet study needs, team objectives, and department goals.
• Developing ability to work across cultures.
• Attention to detail.

We are also open for starters who would like to develop themselves in this direction. If no experience, a strong motivation to develop further into a Start-Up role, however must meet the applicable education requirement.