Hybrid Clinical Operations Specialist – Site & TMF Support

Syneos Health, Inc.; Amsterdam; Hybrid; EUR 60,000 - 85,000; Full time

Job summary

Syneos Health, Inc. in Amsterdam is seeking a Clinical Operation Specialist to support site management, TMF maintenance, and regulatory documentation across multiple studies.

You will coordinate with Clinical Monitoring teams and sponsor sites, ensuring protocol compliance and meticulous record keeping. Required qualifications include a biomedical degree and strong communication skills, with the ability to adapt to new technologies.

Qualifications

• Master or Bachelor degree in a biomedical field.
• Good communication and interpersonal skills.
• Ability to embrace new technologies.

Responsibilities

• 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

Skills

Good communication

Adaptability to new technologies

Education

Biomedical degree

Job description

Syneos Health, Inc. in Amsterdam is seeking a Clinical Operation Specialist to support site management, TMF maintenance, and regulatory documentation across multiple studies.

You will coordinate with Clinical Monitoring teams and sponsor sites, ensuring protocol compliance and meticulous record keeping. Required qualifications include a biomedical degree and strong communication skills, with the ability to adapt to new technologies.