Clinical Trial Specialist II, TMF

Typical Accountabilities

• Assist study team to collect, do basic quality checking and upload trial master files (TMF) in VCV, paper TMF archiving and monitor the eTMF working performance via the reports or the other digital tools to make sure the compliance of eTMF performance targets.
• Assist study team on Site EC/GCP office Submission including submission letter preparation, documents printing & seal and courier to sites within the required timeline. Support study team to collect clinical-regulatory documents for ANGEL publishing for supporting RA submission.
• Implement training to study team on eTMF working process, VCV eTMF system operation and other non-TMF working process via the e-mail, newsletter and internal meeting etc..
• Other administrative tasks assigned, including but not limited study supply (ISF/patient/IP binder preparation) preparation and distribution, TMF translation payment application, TMF printing payment checking, Site Stationary purchasing, the study audits and regulatory inspections support, etc. and other related tasks according to study team requirement.
• Publish Clinical-regulatory documents in ANGEL according to submission-ready standard technical requirements and take the back-up role as DO archivist.
• Support development operation digitalization from study administration perspective.

Education, Qualifications, Skills and Experience
Essential Desirable

• Bachelor degree or above in healthcare-related field, or equivalent.
• At least 3-year experiences as CTA/TMF Administrator or equivalent experience.
• Knowledge in clinical study process and understanding of the ICH/GCP guideline.
• Good interpersonal skills and ability to work in an international team environment
• Ability to train others on study administration procedures.
• Good computer skills in Microsoft and other software.
• Proficient written and verbal communication skills, collaboration and interpersonal skills.
• Proven organizational and administrative skills
• Fluent in both oral and written English.
• Ability to develop advanced computer skills to increase efficiency in day-to-day tasks.
• Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities.
• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Demonstrates ability to prepare and deliver study related training materials.

Date Posted

13-7月-2026

Closing Date

30-8月-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.