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Responsibilities
Study Start Up Strategy & Execution:
Informed Consent Form (ICF) Management:
Assist in preparing/adapting ICFs, supporting IRB/EC/HA submissions and changes, and archiving approvals.
Prepare and manage submission packages for regulatory bodies and health authorities. Assist in responding to RFIs and ensure timely document submission to the TMF. Support study amendments and notifications.
Site Documentation & Compliance:
Collect and verify site documents (CVs, etc.). Assist with translations, patient materials, and biobank details. Learn local document needs and timelines. Support local vendors (excluding CROs) if needed.
Budgeting & Contract Management:
Provide assistance with contract negotiations & execution (confidentiality, indemnity, amendments). Collaborate with internal/external partners on financial/legal compliance. Help update contract system data for planning.
Payment Oversight:
Assist in overseeing site payments, escalations, and reporting via shared service centers and in compliance with site contracts. Help ensure financial/regulatory compliance for local operations. Participate in accrual/purchase order planning and reconciliation.
Requirements
Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master's degree highly desirable
Skills and Competencies
Fluency in written and spoken English is mandatory.
Fluency in written and spoken language(s) of the host country is mandatory.
IMPACT LEVELS
Acquires basic knowledge to assist with study start-up in clinical trials and drug development, including learning about the clinical trial industry and how trials work. Completes tasks following standard procedures and guidance.
Gains practical skills in clinical trial study start-up by assisting with the execution of country clinical trial start-up activities.
Assists with process improvements and changes by completing assigned tasks. Offers basic input based on observations.
Follows directions for clinical trial study start-up projects. Can organize simple tasks.
Works with other groups within PDG to complete assigned tasks in delivering projects.
Learns about and follows ICH, GCP, and regulatory guidelines for clinical trials.
Becomes familiar with other departments and sees how their team's work affects other parts of the business.
Assists administratively in working with selected vendors to support clinical trials and/or enabling projects.
QUALIFICATION LEVELS
Has theoretical knowledge within a job discipline typically gathered through a professional qualification, equivalent working experience or higher level education (e.g. undergraduate). 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.
Benefits
Health insurance
Additional Information
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
Purpose, Objectives and Scope of Position
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.
Roche · Taipei, Taiwan