Project Management Analyst

IQVIA; Kampung Malaysia Tambahan; Presencial; MYR 60.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA in Malaysia is seeking an administrative professional to support clinical trial operations, focusing on TMF/eTMF management, EC submissions, and site startup activities.

You will coordinate document collection, track payments, and assist with site materials distribution, under guidance from the project team. Strong organizational skills and English proficiency are essential to ensure compliant, timely delivery in a fast-paced CRO environment.

Formación

• Bachelor's degree in Pharmaceutical or related field.
• Minimum 0.5 years of clinical trial experience in the pharmaceutical or CRO industry.
• Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and ICH guidelines
• Broad knowledge of applicable protocol requirements as provided in company training
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
• Good written and verbal communication skills including good command of English language
• Excellent organizational skills and ability to prioritize and multitask

Responsabilidades

• TMF: Set up and maintain the site level TMF/eTMF, coordinate on document collection, uploading into SharePoint (SP)/eTMF, check the document completeness, and provide TMF/eTMF quality control (QC) if required.
• EC Submission: Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking.
• Process protocol amendments; may include ICF updates.
• Tracker/Metrics Report: Collect and update study trackers/metrics report for site level if needed.
• Site Contract and Payment: Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking.
• Site Materials and Equipment: Distribute site materials and equipment, document printing, shipment, and other administrative work.
• Administrative: Business and department office administration support if required.
• To undertake other reasonably related duties as may be assigned from time to time, as appropriate for level of experience

Conocimientos

GCP & ICH knowledge

Protocol knowledge

English communication

Organizational skills

Multitasking

Educación

Bachelor's degree in Pharmaceutical or related field

Herramientas

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Descripción del empleo

• TMF: Set up and maintain the site level TMF/eTMF, coordinate on document collection, uploading into SharePoint (SP)/eTMF, check the document completeness, and provide TMF/eTMF quality control (QC) if required.


• EC Submission: Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking.


• Process protocol amendments; may include ICF updates.


• Tracker/Metrics Report: Collect and update study trackers/metrics report for site level if needed.


• Site Contract and Payment: Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking.


• Site Materials and Equipment: Distribute site materials and equipment, document printing, shipment, and other administrative work.


• Administrative: Business and department office administration support if required.


• To undertake other reasonably related duties as may be assigned from time to time, as appropriate for level of experience

Essential Functions

• TMF: Set up and maintain the site level TMF/eTMF, coordinate on document collection, uploading into SharePoint (SP)/eTMF, check the document completeness, and provide TMF/eTMF quality control (QC) if required.


• EC Submission: Coordinate on EC submission dossier, site start-up preparation, and EC fee application and tracking.


• Process protocol amendments; may include ICF updates.


• Tracker/Metrics Report: Collect and update study trackers/metrics report for site level if needed.


• Site Contract and Payment: Assist in contract signature process; assist in site level payment initiative and payment and invoice tracking.


• Site Materials and Equipment: Distribute site materials and equipment, document printing, shipment, and other administrative work.


• Administrative: Business and department office administration support if required.


• To undertake other reasonably related duties as may be assigned from time to time, as appropriate for level of experience

Job Requirements

• Bachelors Degree in Pharmaceutical or related field


• Minimum 0.5 years of clinical trial experience in the pharmaceutical or CRO industry.


• Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines


• Broad knowledge of applicable protocol requirements as provided in company training


• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint


• Good written and verbal communication skills including good command of English language


• Excellent organizational skills and ability to prioritize and multitask

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.