Local Clinical Study Manager – Eastern Europe

🔥 0 minutes ago

🌐 Czechia, Greece, +3 more countries – Remote

🇨🇿 Czechia – Remote 🇬🇷 Greece – Remote 🇭🇺 Hungary – Remote 🇧🇬 Bulgaria – Remote 🇷🇴 Romania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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IQVIA

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

🏭 Manufacturing

📣 Marketing

💰 $1G Post-IPO Debt on 2023-05

Consulting • Manufacturing • Marketing

IQVIA is a global leader in data analytics and technology solutions, dedicated to improving health outcomes. The company utilizes its Connected Intelligence platform to harness the power of advanced data analytics and artificial intelligence, facilitating innovation in healthcare. IQVIA focuses on various areas, including clinical research, technology, and consulting services to solve complex healthcare challenges and accelerate the delivery of new therapies to patients.

📋 Description

• 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