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Clinical Operation Specialist
Syneos HealthClinical Operation Specialist responsible for managing clinical trial activities while ensuring compliance with protocols in The Netherlands. Working with Clinical Monitoring staff and maintaining trial files and documents.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Benefits
Comp & perks- We are passionate about developing our people, through career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- committed to building an inclusive culture
- flexible work hours
- awarded for diversity and inclusion efforts
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Tracking Information ManagementSite Management ActivitiesDocument Preparation And MaintenanceFile Audits ParticipationCase Report Forms Handling
Soft Skills
Interpersonal SkillsWillingness To GrowTeam Coordination