Clinical Project Assistant - Regulatory & Data Support

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 33,000 - 60,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD is seeking a capable administrator to support the clinical team by updating and maintaining clinical systems that track study and site compliance within project timelines.

You will assist in preparing, handling, distributing, filing, and archiving clinical documentation and reports, and support periodic reviews of study files for accuracy and completeness, aiding project filings and data flow.

Qualifications

• Bachelor degree in any science related disciplines.
• Some prior working experience or exposure in regulatory affairs and/or clinical trial management.
• Training will be provided.

Responsibilities

• Assist the clinical team with updating and maintaining clinical systems that track study & site compliance and performance within project timelines.
• Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports.
• Assist with periodic review of study files for accuracy and completeness and to support with project related filing.
• Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow.
• Assist in handling the project-related administrative matters, such as preparation for regulatory submissions, safety report handling, and other logistic issues.
• Assist with Project finance related activities including project expenses invoice preparation and tracking as well as site payment invoice review, preparation and tracking.
• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation including communication with sponsor and vendors as delegated.
• Support any other project related tasks as assigned.

Skills

Regulatory affairs experience

Clinical trial management exposure

Education

Bachelor Degree in Science

Job description

RECRUIT EXPRESS PTE LTD is seeking a capable administrator to support the clinical team by updating and maintaining clinical systems that track study and site compliance within project timelines.

You will assist in preparing, handling, distributing, filing, and archiving clinical documentation and reports, and support periodic reviews of study files for accuracy and completeness, aiding project filings and data flow.