Country Study Start Up Specialist

About the role

The Specialist, Country SSU drives and executes start‑up and maintenance activities for assigned clinical studies and sites in the designated country. The role ensures timely, high‑quality site activation and ongoing support throughout the study lifecycle.

Key responsibilities

• Develop and implement country/site activation plans, including risk assessment and mitigation.
• Collect essential site documents, perform quality checks, and compile ethics and local regulatory packages.
• Coordinate with regulatory, CTS, contract managers, and site monitors to ensure timely site activation and clinical supply shipments.
• Track start‑up activities in Vault SSU, maintain site intelligence databases, and report performance metrics.
• Ensure audit/inspection readiness and compliance with corporate policies and worldwide regulations.

Required profile

• Bachelor's degree in a health‑care or scientific field or equivalent experience.
• 1‑2 years of clinical research experience, with at least 1 year in study start‑up management.
• Strong interpersonal skills, ability to work with remote/virtual teams, and manage multiple priorities.
• Working knowledge of ICH and GCP guidelines and the local regulatory environment.

Required skills

• ICH guidelines
• GCP guidelines