Clinical Operation Specialist

Jobtailor; Haarlem; On-site; EUR 42,000 - 60,000; Full time

Job summary

Jobtailor in the Netherlands seeks a clinical operations professional to support site management and sponsor communications, ensuring protocol compliance and smooth study conduct. You will assist Clinical Monitoring staff with site activities and help manage TMF and project files to support audits.

Responsibilities include maintaining site manuals, updating tracking databases, coordinating site documents and meeting minutes, and handling site supply logistics from our Haarlem office.

Qualifications

• Master's degree in biomedical sciences or equivalent.
• Affinity with clinical research.
• Good communication and interpersonal skills.
• Willing to grow further in the industry.
• Fluency in Dutch.
• Ability to embrace new technologies.
• Willing to work from Haarlem office regularly.

Responsibilities

• Assist Clinical Monitoring staff with site management and sponsor communication.
• Maintain Trial Master File (TMF) and project files; participate in file audits.
• Prepare and maintain site manuals and reference tools.
• Update clinical tracking information in databases.
• Track incoming/outgoing regulatory documents for sites and projects.
• Manage shared mailbox and process site requests.
• Coordinate ordering, packaging, shipping, and tracking of site supplies.
• Attend meetings and prepare accurate minutes and actions.
• May handle receipt, tracking and disposition of Case Report Forms and Queries.
• Maintain field awareness of clinical research through required training.

Skills

Good communication

Dutch fluency

Growth mindset

Clinical research affinity

Tech-savvy

Education

Master's degree in biomedical sciences

Job description

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits
• Prepares and maintains site manuals, reference tools and other documents
• Maintains, updates, and inputs clinical tracking information into databases
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client
• Manages shared mailbox, processes site requests and routes correspondence appropriately
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items
• May handle receipt, tracking and disposition of Case Report Forms and Queries
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training

Requirements

• Master degree in biomedical sciences or equivalent
• Affinity with clinical research
• Good communication and interpersonal skills
• Willing to grow further in the industry
• Fluency in Dutch
• Ability to embrace new technologies
• Willing to work from the Haarlem office on a regular basis