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Associate/Clinical Project Manager, Sponsor Dedicated

iqvia · Seoul

New
Mid 🇬🇧 English
ICH-GCP CTMS eTMF/IF

Job description

About the role

iQVIA's Local Trial Management services provides local management of a clinical trial or Medical Affairs data generation activity in a country or countries, from start-up through database lock and closeout. The Associate/Clinical Project Manager acts as the primary company contact for the assigned trial at country level, partnering with the Clinical Trial Assistant, Clinical Research Associates, and the Central Trial Manager to ensure quality data and compliance with the protocol, SOPs, ICH-GCP and regulatory requirements.

Key responsibilities

  • Contribute to site selection through site feasibility, site qualification visits and follow-up of reports, and collaborate with the central study team on site choice.
  • Help the local team meet recruitment targets with high-quality data on time and within budget, including recruitment planning, risk management and budget forecasting.
  • Act as primary company contact, attend or run investigator meetings, and drive compliance by maintaining trial management systems and initiating CAPA when needed.
  • Manage vendors at country level, including vendor selection, invoice review and approval, and local study supply.
  • Run quality local team meetings, facilitate CRA training, prepare country-specific informed consent, and ensure timely reporting of AEs/SAEs/PQCs.
  • Maintain inspection readiness in CTMS and eTMF/IF, escalate deviations, and keep up to date with training and therapeutic knowledge.
  • Work with the CRA on CAPA after audits or inspections, and support finance reporting and budget control, including site contract and budget negotiation where applicable.
  • Organize IEC/HA approvals with the local start-up team and may train on systems or contribute to process improvements.

Required profile

  • BA/BS degree, preferably in a health or science-related field.
  • 2 years of local trial management or mutually agreed clinical trial experience; specific therapeutic area experience may be required.
  • Proficiency in the country language and English, with good written and oral communication.
  • Willingness to travel occasionally, including overnight stays.

Required skills

  • Strong working knowledge of ICH-GCP, company SOPs, local laws and regulations, and assigned protocols.
  • Strong IT skills in the relevant software and company systems.

Questions fréquentes

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Source : ats:workday

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Published 2 hours ago

Expires 1 month from now

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iqvia

Seoul