Admin Assisstant - 1 year contract

Key Responsibilities
Provide administrative support to Clinical Operations team (CCOMs, COMs, CRAs, and other clinical staff) to support project and departmental goals

Organize, maintain, and archive clinical trial documentation (eTMF, ISF, binders)

Assist in quality control audits and maintain accurate tracking of trial progress and documentation

Manage shared mailbox communications and maintain shared drives, including archiving and documentation updates

Coordinate ordering, packaging, shipment, and tracking of study materials and site supplies

Support site training visits (STV), including documentation preparation and coordination with clinical sites

Assist with meeting coordination, preparation of minutes, action items, and departmental presentations

Support payment processes, including tracking, invoicing, and coordination with internal stakeholders

Ensure compliance with ICH GCP guidelines, company SOPs, and regulatory requirements

Complete required training related to clinical research

Malaysia-Specific Responsibilities:

Prepare and submit regulatory documents to NPRA for clinical trials

Manage clinical trial import licenses, renewals, and submissions

Coordinate contract stamping, tracking, and distribution of agreements

Handle documentation filing, vendor coordination, and compliance tracking

Support device and material destruction processes in coordination with HR

Requirements
Bachelor’s Degree in Life Sciences, Pharmacy, Health Sciences, Business Administration, or related field

Minimum college-level education (or equivalent) required

Good command of English (written and spoken)

Strong organizational and time management skills with attention to detail

Ability to manage multiple tasks in a fast-paced environment

Good interpersonal and teamwork skills

Proficient in MS Office and web-based systems (clinical systems experience is an added advantage)

Ability to work independently with minimal supervision

Willingness to learn and adapt to new technologies

Able to travel occasionally (up to 10%)