Study Start Up Specialist

About the role

As a member of Roche’s PDG Country Study Start‑Up Team, you will drive and facilitate efficient study start‑up processes to ensure clinical trials reach patients on time. The role involves collaborating with local country teams, global study teams and CROs to enable innovative trial delivery across therapeutic areas.

Key responsibilities

• Support and execute study start‑up strategies for faster site activation, working with internal teams, CROs and sites while ensuring compliance with regulations and SOPs.
• Prepare and adapt Informed Consent Forms, support IRB/EC/Health Authority submissions, manage changes and archive approvals.
• Create and manage regulatory submission packages, respond to RFIs and ensure timely document filing in the trial master file.
• Collect and verify site documentation (CVs, biobank details, patient materials), assist with translations and support local vendors.
• Assist with contract negotiations, confidentiality and indemnity clauses, and update contract system data for planning.
• Oversee site payments, handle escalations, report through shared service centres and support accrual and purchase‑order reconciliation.

Required profile

• Degree in life sciences (MD, PhD, MA/MS, BA/BS) or equivalent.

Required skills