Study Start‑Up Specialist II

About the role

The Study Start‑Up Specialist II supports the activation of clinical trial sites by coordinating all pre‑activation activities. This role ensures regulatory, ethics and contractual requirements are met efficiently, enabling timely study launch.

Key responsibilities

• Coordinate site Informed Consent Form localization and ensure compliance with health authority requirements.
• Manage ethics committee submissions, meeting schedules, and associated costs.
• Oversee clinical trial health authority applications and regulatory submissions.
• Facilitate contract and indemnity request processes, negotiating budgets and fees.
• Maintain up‑to‑date documentation in a central repository for global and local study teams.
• Track start‑up metrics, identify trends, and drive process improvements.
• Liaise with ethics committees, hospital administrations, and government bodies to obtain accurate trial status information.
• Provide guidance to Country Study Managers on regulatory and ethics matters.
• Assist in new site identification, feasibility assessments, and site selection.
• Collaborate with vendor management and procurement during RFI/RFP processes.

Required profile

• Up‑to‑date knowledge of local regulatory and ethics requirements for clinical trials.
• Proven ability to coordinate multi‑disciplinary start‑up activities across sites.
• Experience liaising with ethics committees, health authorities and other regulatory bodies.
• Strong organizational skills to manage timelines, metrics and documentation.

Required skills