Study Start-Up Specialist in Amsterdam (fulltime)

  • Antareslaan 41, 2132 JE Hoofddorp, Netherlands
  • Full-time

Company Description

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).

Job Description

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.

Qualifications

  • 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.

Additional Information

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.

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