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

• 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

• 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