Local Clinical Study Manager – Eastern Europe
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Job Description
Clinical Study Manager overseeing oncology and onco-hematology trials for IQVIA across Eastern Europe. Leading clinical teams, site activation, monitoring, regulatory delivery, and study execution.
Responsibilities:
- Plan and lead day-to-day activities for monitoring complex clinical studies
- Communicate project objectives, expectations, and status updates to clinical teams
- Take overall responsibility for country study commitments and timely, high-quality data delivery
- Provide project oversight and leadership for clinical deliverables
- Lead and manage clinical teams and relevant local and global staff
- Drive successful activation of trial sites
- Monitor clinical activity quality and address quality issues
- Review and approve site visit reports and ensure tracking, follow-up, and resolution of site issues
- Identify data-related issues and risks and develop contingency and mitigation plans
- Create and maintain project-specific plans, documents, and tools
- Support CRAs with site monitoring activities and provide solutions to site issues
- Oversee regulatory and in-house clinical staff to ensure required updates, reports, renewals, and end-of-study notifications comply with protocols, local regulations, ICH GCP, and governing procedures
- Coordinate training, processes, systems-related activities, and ad-hoc activities
Requirements:
- Bachelor degree in related discipline, preferably in life science
- Five or more years of experience in clinical research, including a minimum of 2 years' project management experience, or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job
- Good knowledge of international guidelines ICH GCP and relevant local regulations
- Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and required quality
- Previous work experience in Oncology or Onco-hematology is required
- Good knowledge of the Drug Development Process
- Excellent knowledge of spoken and written English language
- Good ability to learn and adapt to work with IT systems
- Effective decision-making ability
- Experience monitoring study activities for compliance and inspection readiness
- Strong interpersonal skills for collaborating with internal teams, stakeholders, and external vendors
- Deep understanding of clinical operations processes, including trial data collection and management
Benefits:
- Full-time, home-based setting
- Opportunity to manage clinical research projects in different therapeutic areas
- Opportunity to cooperate closely with a key client
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