Sr. Clinical Data Manager (Europe) in Amsterdam

Overview

In this role you lead the Allucent Data Management team to ensure high-quality, regulatory-compliant clinical data from setup to lock. You will collaborate with cross-functional groups and external partners to shape DM processes, tools, and training. Your work directly supports accurate analyses and reporting across studies and therapeutic areas. This is a data-driven, operationally impactful position in a fast-growing company with a strong client focus.

Arbeidsvoorwaarden / Benefits

• Comprehensive benefits package per location
• Flexible working hours
• Remote/office-based opportunities depending on location
• Leadership and mentoring opportunities
• Buddy Program
• Internal growth and career progression

Verantwoordelijkheden

• Lead DM activities and serve as primary DM contact with internal and external stakeholders
• Plan resources, timelines, risks, and quality for DM projects
• Monitor budgets and manage scope changes and revenue recognition
• Develop and maintain DM documents (DMP, eCRF specs, DVP, data transfer agreements)
• Oversee study database set-up, eCRF design, and validation requirements
• Coordinate study document reviews and eCRF approvals
• Manage User Acceptance Testing (UAT) tasks
• Create training materials for EDC users and deliver project-specific training
• Validate and ensure data consistency, accuracy, integrity, and completeness
• Create data cleaning strategies and oversee data releases
• Coordinate data transfers and reconciliations (SAE, PK, external lab data)
• Provide project metrics and status updates to the team
• Lead Quality Review activities during studies
• Assist in contract negotiations with vendors (EDC, IRT, eCOA)
• Maintain DM study documentation and support audits
• Align DM practices with company standards and best practices
• Provide leadership and mentorship to DM staff
• Lead DM-related meetings and share information across the department
• Represent the company at meetings, webinars, and seminars
• Support new proposals and budgets for Data Management services
• Contribute to Quality Management System processes as SME
• Support client relations and evaluations
• Plan and participate in staff training and development
• Track regulatory developments to improve processes
• Contribute to process improvements and efficiency initiatives
• Support cross-functional staff development and onboarding
• Participate in interview process for new recruits
• Manage vendor relationships and project delivery timelines
• Ensure filing and documentation up-to-date
• Plan documentation for internal and external audits

Belangrijkste vereisten

• Life science background and/or relevant experience in clinical data management
• Minimum 5 years of DM experience in drug development/clinical research
• Strong knowledge of ICH-GCP, 21 CFR 11, GDPR/HIPAA considerations
• Experience with electronic data capture (EDC) and related tools (IRT, eCOA)
• DM lead on multiple studies across therapeutic areas and phases
• Understanding of relational databases and data management practices (validation, testing, documentation)
• Experience with CDISC standards (CDASH, TAUG) and implementing these models
• Excellent written and verbal English communication
• Client-focused and representative with strong collaboration
• Proficiency with Word, Excel, PowerPoint; strong administrative skills
• Strong project management, problem-solving, and organizational abilities
• Ability to translate complex guidelines into actionable recommendations
• Negotiation and motivational skills
• Attention to detail and data quality discipline
• Ability to thrive in a fast-paced, growing company

• cliente-focused
• cross-functional collaboration
• communication
• EDC systems
• IRT
• eCOA