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Administrator

1 month ago


Petaling Jaya, Malaysia Bright Prospect Full time

Degree or Diploma in Business Administration / Business Management / Life Science or equivalent.
- 2-3 years working experience in administrative with the medical/ life science field
- Good organizational and administrative skills
- Detail-oriented, multitasking, team oriented and flexible
- Good verbal and written communication
- Computer proficiency

**Responsibilities**:

- Assists in coordination and administration of clinical studies from the start-up to execution and close-out.
- Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents.
- Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
- Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance.
- Ensures essential documents under their responsibility are uploaded in a timely.
- Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
- Contributes to the production and maintenance of study documents, ensuring template and version compliance.
- Creates and/or imports clinical-regulatory documents into the Global Electronic Management System
- Sets-up, populates and accurately maintains information in tracking and communication tools and supports others in the usage of these systems.
- Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
- Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP) payments in accordance with local regulations.
- Manages and contributes to coordination and tracking of study materials and equipment.
- Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
- Leads the practical arrangements and contributes to the preparation of internal and external meetings e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and external participants and/or vendors, in line with international and local codes.
- Prepares, contributes to and distributes presentation material for meetings, newsletters and web-sites.
- Responsible for layout and language control, copying and distribution of documents.
- Supports with local translation and spell checks in English to/from local language, as required.
- Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.
- Ensures compliance with company’s Code of Ethics and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
- Ensures compliance with local, national and regional legislation, as applicable