Study Start‑Up Specialist

About the role

Roche is seeking a Study Start‑Up Specialist to join its Global Clinical Operations team. The role focuses on accelerating the initiation of Roche‑sponsored clinical trials while ensuring regulatory compliance and seamless collaboration with sites, CROs, and internal stakeholders.

Key responsibilities

• Support and execute study start‑up strategies to achieve faster site activations across therapeutic areas.
• Assist with clinical site budgeting, contract negotiations, and management of confidentiality agreements, indemnities, and protocol amendments.
• Oversee site payments, handle escalations, and ensure financial and regulatory compliance.
• Prepare and submit regulatory packages, respond to requests for information, and maintain documentation in trial master file systems.
• Track submissions, monitor regulatory updates, and coordinate with global study teams.

Required profile

• Degree in life sciences (MD, PhD, MA/MS, BA/BS); postgraduate degree highly desirable.
• Practical operational experience in clinical trial start‑up and regulatory submissions.
• Proven ability to work cross‑functionally with internal teams, CROs, and external partners.

Required skills