Clinical Research Manager

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Serve as the line manager for trial monitoring personnel (CRAs) in Belgium.

• Organize, delegate, and oversee work; evaluate performance and support the professional growth of direct reports.

• Engage in the hiring process and allocate resources for clinical research projects.

• Assign team members to clinical studies based on their experience and training.

• Ensure that clinical trial protocols are followed in accordance with ICH/GCP, local regulations, and relevant SOPs.

• Work collaboratively with the Regional Clinical Operations Manager to uphold study timelines and quality benchmarks.

• Assist with study initiation and provide local expertise.

• Manage study initiation and trial monitoring personnel in compliance with company policies and regulations.

• Oversee the onboarding and training of new hires and manage training programs.

• Ensure the quality of clinical work performed by assigned staff through regular reviews and evaluations.

• Offer country-specific expertise for study initiation and review study documents, drug labels, ICFs, and templates.

• Develop and evaluate site-specific recruitment materials and tools.

• Collaborate with study teams and clinical sites on IRB/EC submissions, TMF completeness, site activation, enrollment, and readiness for inspections.

• Contribute to feasibility assessments, site identification, selection, and evaluation.

• Conduct accompanied CRA visits and evaluate performance.

• Review visit reports, follow up on resolving issues, and communicate significant risks and recommended actions.

• Monitor workload and quality metrics through regular reviews and reporting.

• Proactively identify and address site issues, propose CAPAs, identify gaps, and leverage opportunities.

• Foster operational excellence and innovation.

• Contribute to the strategy and performance of Clinical Operations against key metrics.

• Mentor and supervise junior staff and Clinical Research Associates.

• Act as an escalation point for CRA-related site issues.

• Conduct mid-year and year-end performance evaluations for direct reports.

⛳️ Requirements

• Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline.

• At least 5-7 years of progressive experience in clinical operations within the biotech/pharmaceutical industry.

• Previous clinical trial experience, including a management or leadership role.

• Experience in oncology is strongly preferred.

• Capability to work independently and effectively manage multiple priorities in a dynamic environment.

• Minimum of 5-7 years of progressive experience in clinical operations, ideally with at least 2 years in line management within the pharmaceutical or CRO sector.

• Outstanding interpersonal and organizational skills.

• Fluent in German and the local language (both written and spoken).

• Proficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

• Willingness to travel up to 30-40% of the time.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible working arrangements.

• Collaborative and supportive work environment.