Site Start-Up & Submissions Specialist (Hybrid)

Syneos Health; Amsterdam; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Syneos Health is seeking a Submission Specialist to join our Netherlands team in Hoofddorp on a hybrid schedule (2-3 days onsite). This role focuses on country-level submissions, maintaining compliance with country rules, timelines, and SSU tracking systems, and ensuring timely TMF documentation.

You will oversee local EC/RA submissions, prepare and submit regulatory materials, support site activation, and collaborate with the CSA and SAM.

Qualifications

• Bachelor’s Degree in a relevant field.
• Knowledge of clinical trial processes across Phases II–IV and ICH GCP.
• Ability to manage external vendors effectively.
• Strong organizational and multitasking abilities.
• Proficient written and verbal communication and interpersonal skills.
• Fluency in Dutch and English.

Responsibilities

• Ensure quality deliverables at the country level and track timelines.
• Monitor financial aspects and hours available per contract; escalate discrepancies.
• Review SOPs and WI; keep training records updated and timesheet compliant.
• Support continuous improvement of Site Start-Up components at country level.
• Submit required documents to the Trial Master File per SOPs and sponsor requirements.
• Serve as liaison for PM/SAM and assist with site activation and regulatory submissions.

Skills

Dutch language

English language

Strong organizational skills

Negotiation skills

Problem-solving skills

Communication skills

Teamwork

Education

Bachelor's Degree

Job description

Syneos Health is seeking a Submission Specialist to join our Netherlands team in Hoofddorp on a hybrid schedule (2-3 days onsite). This role focuses on country-level submissions, maintaining compliance with country rules, timelines, and SSU tracking systems, and ensuring timely TMF documentation.

You will oversee local EC/RA submissions, prepare and submit regulatory materials, support site activation, and collaborate with the CSA and SAM.