IQVIA
IQVIA
IQVIA combină analiza datelor din domeniul sănătății, tehnologia avansată și serviciile de consultanță pentru a ajuta organizațiile să abordeze provocări complexe din sectoarele științelor vieții și al asistenței medicale. Platforma sa Connected Intelligence reunește date și inteligență artificială pentru a sprijini cercetarea clinică, dezvoltarea tehnologică și progresul unor terapii noi. Echipele companiei lucrează în domeniile analizei datelor, consultanței și tehnologiei medicale, oferind oportunități legate de cercetare, inovare digitală și eforturi de îmbunătățire a rezultatelor pentru pacienți.

Local Clinical Study Manager, Eastern Europe (Remote)

Lead oncology and onco-hematology clinical trials across Eastern Europe for IQVIA. Oversee clinical teams, site activation, monitoring, regulatory delivery, and study execution.

Descriere

  • Direct daily monitoring activities for complex clinical studies
  • Share study objectives, expectations, and progress updates with clinical teams
  • Own country-level study commitments and ensure timely, high-quality data delivery
  • Provide oversight and leadership for clinical deliverables
  • Manage clinical teams and applicable local and global staff
  • Lead the successful activation of trial sites
  • Monitor the quality of clinical activities and resolve quality concerns
  • Review and approve site visit reports while tracking, following up on, and resolving site issues
  • Assess data-related risks and issues and create contingency and mitigation plans
  • Develop and maintain study-specific plans, documentation, and tools
  • Assist CRAs with site monitoring and help resolve site-level challenges
  • Supervise regulatory and internal clinical staff to ensure updates, reports, renewals, and end-of-study notifications meet protocols, local regulations, ICH GCP, and applicable procedures
  • Coordinate training, process activities, system-related work, and ad hoc tasks

Cerințe

  • Bachelor’s degree in a related field, preferably life sciences
  • At least five years of clinical research experience, including two or more years in project management, or an equivalent combination of education and experience sufficient to perform the role successfully
  • Working knowledge of ICH GCP international guidelines and applicable local regulations
  • Demonstrated ability to lead and motivate cross-functional teams to deliver clinical trials on or ahead of schedule, within budget, and to the required quality standards
  • Professional experience in oncology or onco-hematology is required
  • Solid understanding of the drug development process
  • Excellent spoken and written English
  • Ability to learn and adapt to clinical IT systems
  • Sound decision-making skills
  • Experience monitoring study activities for compliance and inspection readiness
  • Strong interpersonal skills for working with internal teams, stakeholders, and external vendors
  • Thorough understanding of clinical operations, including trial data collection and management

Beneficii

  • Full-time, home-based work arrangement
  • Opportunity to manage clinical research projects across multiple therapeutic areas
  • Close collaboration with a key client

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