Local Clinical Study Manager – Belgium, Denmark, Netherlands, Sweden

🔥 0 minutes ago

🌐 Belgium, Denmark, +2 more countries – Remote

🇧🇪 Belgium – Remote 🇩🇰 Denmark – Remote 🇳🇱 Netherlands – Remote 🇸🇪 Sweden – 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

• Provides overall clinical study leadership and oversight for trial delivery, execution, quality, timelines, and outcomes • Leads and manages cross-functional clinical teams, setting priorities, expectations, and ensuring effective communication • Plans and oversees daily study monitoring activities, providing status updates and driving study progress • Manages vendors and budgets, when applicable, and coordinates resources to support study objectives • Drives site activation and startup activities, collaborating with regulatory, startup, and in-house teams • Monitors study quality and compliance, identifying risks, implementing mitigation plans, and addressing issues proactively • Reviews and approves monitoring reports, ensuring timely follow-up and resolution of site-related findings • Develops and delivers study-specific training and supports ongoing development of clinical staff and CRAs • Analyzes study metrics and trends, using data to improve execution, consistency, and quality across countries and regions • Ensures regulatory compliance, including submissions, approvals, renewals, reporting requirements, and adherence to ICH-GCP and local regulations • Oversees Trial Master File (eTMF) quality, ensuring essential documents are complete and compliant • Partners with Quality Assurance on audits, CAPA activities, and inspection readiness • Acts as the primary point of contact for clinical monitoring issues, coordinating communication across stakeholders and vendors • Facilitates proactive problem-solving and escalation management across cross-functional teams • Maintains project plans, tools, systems, and reporting to ensure accurate project tracking and visibility

🎯 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 as well as 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 with required quality • Previous work experience in TA's: Oncology or Onco-hematology is required • Good knowledge of the Drug Development Process • Excellent knowledge of spoken and written English and local language • Good ability to learn and to adapt to work with IT systems • Experience in 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