Study start up Specialist

Overview

Study Start Up Specialist within Roche Pharma Global Clinical Operations in Mumbai, driving efficient study start-up processes and site activations for clinical trials across therapeutic areas.

What you'll do

• Support and execute study start-up strategies to accelerate site activations, collaborating with internal teams, external partners, CROs, and clinical sites.
• Prepare and manage regulatory submission packages for Health Authorities and Ethics Committees (EC/IRB), including adapting Informed Consent Forms, responding to RFIs, and managing study amendments.
• Collect, verify, and submit essential site documentation (e.g., CVs, patient materials, biobank details) to the Trial Master File while ensuring adherence to local regulatory requirements and SOPs.
• Assist with negotiation and execution of clinical trial contracts, managing confidentiality, indemnity, and amendments while working with cross-functional partners to ensure legal and financial compliance.
• Oversee site payments, coordinate accrual and purchase order reconciliations via shared service centers, and proactively manage escalations and reporting.
• Act as a subject matter expert to identify potential start-up bottlenecks early, support local vendors, and keep systems updated with accurate tracking and contract data.

What you'll need

• University degree (MD, PhD, MA/MS, BA/BS) in life sciences or an equivalent field.
• Strong understanding of clinical trial regulations, Health Authority/Ethics Committee guidelines, and SOPs necessary for effective study start-up and execution.
• Highly collaborative and comfortable working in cross-functional environments with global study teams, CROs, clinical site staff, and local vendors.
• Keen eye for detail with experience in managing complex documentation, budgeting, site payments, or contract negotiations.
• Highly organized and proactive, capable of managing multiple priorities, tracking systems, and compliance requirements efficiently.
• Fluent in both written and spoken English, as well as the local language(s) of the host country.

Nice to have

• Postgraduate or master's degree.

Details

• Location: Mumbai.