Clinical Trial Management Associate

IQVIA

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profile Job Location:

Kuala Lumpur - Malaysia

profile Monthly Salary: Not Disclosed
Posted on: Yesterday
Vacancies: 1 Vacancy

Job Summary

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 Pharmaceuticalor related field

  • Min. 1 - 2 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

  • Office-based (5 days)

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

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.


Required Experience:

IC

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 preparatio...
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Key Skills

  • Portfolio Management
  • Wealth Management
  • Financial Services
  • Hybris
  • Microsoft Word
  • Banking
  • Cash Management
  • Data Management
  • Microsoft Powerpoint
  • Securities Law
  • Microsoft Excel
  • Internet Of Things

About Company

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IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more

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