Project Management Analyst

IQVIA; Kuala Lumpur; Vor Ort; MYR 30.000 - 54.000; Vollzeit

Zusammenfassung

IQVIA in Kuala Lumpur is seeking an administrative coordinator to support clinical trial operations.

You will maintain TMF/eTMF at site level, coordinate EC submissions, assist with contracts, payments, and site logistics, and handle standard office tasks.

Qualifikationen

• Bachelor's degree in pharmaceutical or related field.
• Minimum 0.5 years of clinical trial experience in pharma/CRO.
• Basic knowledge of GCP and ICH guidelines.
• Proficient in MS Word, Excel and PowerPoint.
• Good written and verbal English communication.
• Excellent organization and multitasking abilities.

Aufgaben

• Set up and maintain site TMF/eTMF; coordinate document collection and upload into SP/eTMF.
• Coordinate EC submission dossiers and site start-up preparation.
• Process protocol amendments and ICF updates as needed.
• Collect and update study trackers/metrics at site level.
• Assist in contract signing, site payment initiation and payment tracking.
• Distribute site materials and handle related admin tasks.
• Provide general administrative support as required.
• Undertake other related duties as assigned.

Kenntnisse

Strong communication

Organizational skills

Multitasking

Ausbildung

Bachelor's degree in Pharmaceutical or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Jobbeschreibung

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.

About IQVIA

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.

We create connections that accelerate the development and commercialization of innovative medical treatments.

Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.

No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.