Study Start-Up Specialist (SSUS)

As a member of the PDG Country Study Start-Up Team, your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery, address study start up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff. Collaboration with local country teams, global study teams, and CROs is essential to this role. This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by executing effective start-up strategies while maintaining regulatory compliance. Additionally, this role involves managing amendments throughout the study lifecycle. You will bring subject matter expertise and may work cross functionally in the following areas below:

• Study Start-Up Strategy & Execution
• Informed Consent Form (ICF) Management
• Clinical Trial Submissions & Regulatory Coordination
• Site Documentation & Compliance
• Budgeting & Contract Management
• Payment Oversight

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• Has theoretical knowledge within a job discipline typically gathered through a professional qualification, equivalent working experience or higher level education (e.g. undergraduate).
• Awareness of clinical operations and the industry and (0~3) years of relevant experience in clinical trial operations are preferred.
• Performs assignments within existing procedures and instructions.
• Works on assigned problem areas. Follows provided steps and instructions to resolve issues. May need assistance to determine next steps or who to contact.