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Associate Centralized Monitor – German Speaker

iqvia · Bratislava

New
Mid 🇬🇧 English
EDC IXRS CTMS Microsoft Office Excel PowerPoint

Job description

About the role

IQVIA is looking for an Associate Centralized Monitor who speaks German to provide project-related assistance to assigned project teams. The role ensures that work follows standard operating procedures, policies, good clinical practice and regulatory requirements, while meeting quality and timeline metrics.

Key responsibilities

  • Complete role-specific training and, under supervision, provide administrative support to the clinical study management team (system reports, status reports, study trackers, follow-up on outstanding issues).
  • Maintain systems and tracking tools, prepare i-site packs for sites and countries, and perform centralized monitoring of assigned sites against protocol, SOPs and regulations.
  • Follow up with sites and CRAs on missing data, pending queries, SDV backlog, visit schedules and PD, and manage site communication.
  • Help leads maintain internal systems, databases and project plans, and manage operational insight of sites and studies through trend analysis, alert triage and COP compliance monitoring.
  • Perform subject-level data review, study-specific analytics and access management tasks such as processing access requests and vendor follow-ups.
  • Act as backup for Centralized Monitors and Senior Centralized Monitors, support the technical solution specialist with Excel formulas, macros and tool design, and identify site-level risks and recommend corrective actions.
  • Review the Study Central Monitoring Plan and adhere to the SOW as required by the customer.

Required profile

  • Graduate or postgraduate in Life Sciences or a related field.
  • Minimum of 2 to 5 years of work experience, with at least 1 year relevant; experience level may vary with customer requirements.
  • Good knowledge of ICH-GCP and relevant local laws, regulations and guidelines.
  • Strong written and verbal communication skills, including a good command of English and German.
  • Attention to detail, problem-solving, planning and time-management skills, and strong data entry and software skills.

Required skills

  • Proficiency in clinical systems such as EDC, IXRS or CTMS or equivalent.
  • Experience managing global phase trials, clinical trial systems and/or reviewing clinical trial data.
  • Microsoft Office, including Word, Excel and PowerPoint.

Questions fréquentes

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Source : ats:workday

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Published 8 hours ago

Expires 1 month from now

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iqvia

Bratislava