Clinical Research Administrator (MNC Pharma) x2

Location: Petaling Jaya, Selangor

Job Descriptions:

• Supports in organizing and managing clinical studies throughout the initiation, execution, and conclusion phases.
• Collects, prepares, reviews, and tracks documents for study applications. Supports timely submission to ethics committees/institutional review boards and regulatory authorities throughout the study.
• Participates in creating and up-keeping study documents, ensuring adherence to templates and versions.
• Supports electronic applications/submissions by managing clinical-regulatory documents in accordance with specified technical standards (Submission Ready Standards), ensuring efficient publishing and delivery to regulatory authorities.
• Manages logistical aspects and contribute in planning internal and external meetings.
• Coordinates with internal and external participants and vendors, ensuring adherence to international and local codes.
• Coordinates administrative tasks during the study process, audits and regulatory inspections, according to company policies and SOPs.
• Manages document layout, language control, copying, and distribution. Assists in local translation and spell checks between English and local languages as needed.
• Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.
• Ensures compliance with local, national and regional legislation, as applicable

Job Requirements:

• A Bachelor Degree in Life Science, Medical Science, Biomedicine, or equivalent.
• Applicant with administrative experience preferably in the medical/ life science
• Familiarity with the Clinical Study/ Clinical Research Process and comprehension of related working procedures, coupled with knowledge of ICH-GCP guidelines.
• Computer proficiency.
• Good verbal and written communication. English.
• Good interpersonal skills and ability to work in an international team environment.
• Demonstrates strong organizational and time management skills, attention to detail, and the ability to multitask in a dynamic, high-volume environment with changing priorities.
• Integrity and high ethical standards.

Benefits:

• Working hybrid
• Bonus
• Parking Claim
• Optical & Dental

Others Information:

For those who have what it takes, please send in resume to:
Recruitment Consultant : Janice / Wei Li
Email: janice@brightprospect.com.my