Contract Site Start-Up Specialist

Syneos Health Netherlands B.V.; Netherlands; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

Syneos Health is seeking a Temporary Start-up Specialist in the Netherlands, based in Amsterdam, to drive country-level site start-up activities. You will manage regulatory submissions, vendor coordination, and timelines with support from the SSU team, ensuring compliant submissions and timely activation of sites across trials.

The role requires a Bachelor's degree, strong knowledge of ICH GCP and regional regulations, excellent organizational and negotiation skills, and the ability to work

Qualifikationen

• Detailed understanding of clinical trial start-up processes and regulatory requirements.

Aufgaben

• Responsible for quality deliverables at country level; follows project requirements with moderate oversight.
• Monitors submission timelines and tracks milestone progress in SSU system; escalates delays with rationale.
• Prepares and submits Central/Local EC Applications, RA Applications, and other local regulatory submissions as needed.
• Oversees site activation end-to-end at country/site level; liaises with PM/SAM and CSA as needed.
• Provides input to local SOPs/WIs and supports training materials on local legislation requirements.

Kenntnisse

Clinical Start-Up Knowledge

Regulatory Submissions

Vendor Management

Project Coordination

Cross-functional Collaboration

Communication Skills

Problem-solving

Ausbildung

Bachelor's Degree

Jobbeschreibung

Syneos Health is seeking a Temporary Start-up Specialist in the Netherlands, based in Amsterdam, to drive country-level site start-up activities. You will manage regulatory submissions, vendor coordination, and timelines with support from the SSU team, ensuring compliant submissions and timely activation of sites across trials.

The role requires a Bachelor's degree, strong knowledge of ICH GCP and regional regulations, excellent organizational and negotiation skills, and the ability to work