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

Primary Purpose of Job

Clinical Trial Document Preparation and Archiving
·Be familiar with the content of clinical trial master file and
investigator site file based on the requirements of ICH GCP, China regulation
and Roche SOPs, guidance.
·Support to prepare site file before study start up
·Review the closed clinical trial documents, support archiving
responsible to arrange and archive them according to related SOP requirements.

Business Support to Department
·Understand ICH GCP, China GCP and related regulation on clinical trials.
·Support SSUS to prepare the essential EC submission package according to
required timeline.
·Support SSUS on site budget and contract preparation.
·Maintains and analyzes study data (metrics) on assigned studies. Support
PDG China to identify opportunities for continuous improvement
·Update and maintain the data in CDE platform according to regulatory and
SOP requirements.
·Support local clinical operation data cleaning and management

General Office Duties
·Provide general office support to PDG China department staff (including
but not limited to photocopying, distributing mail/faxes, scanning, faxing,).
·Organize courier services for documents/ goods pick-up.
·Help to arrange meetings or meeting logistics

·Perform other tasks, as assigned by line manager

Qualification and Experience

Education/Qualifications
·Bachelor degree or above
·Major in public health, data science, computer science, pharmacy,
biology or related

Personality
·Good ownership and focus on details

·Logical and efficient with highly compliance

·Be willing to learn, think and practice

Job Required Competencies

·Strong computer skill for Window 7, Microsoft 2010 (PPT, Excel, Word)

·Strong communication skills
·Fluent English written and oral capability

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.