Senior Clinical Data Management Lead

5 dagen geleden


Amsterdam, Noord-Holland, Nederland Allucent Voltijd
Job Description

The role of Sr. Clinical Data Manager at Allucent offers an exciting opportunity to lead data management activities for our company's clinical trials. As a key member of the Data Management department, you will oversee the collection, analysis, and dissemination of data to support regulatory submissions and business decisions.

About Allucent

We are a dedicated team at Allucent that helps small-medium biopharmaceutical companies navigate the complex world of clinical trials efficiently. Our goal is to bring life-changing therapies to patients worldwide by providing high-quality services in data management.

Key Responsibilities
  • Lead and serve as primary contact for Data Management with all relevant parties internally (Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics) and externally (sponsors, vendors, and investigational sites).
  • Plan and project resources required, including task management, timelines, risk, and quality.
  • Monitor tasks against budget, forecasts, and manage changes of scope, budget, revenue recognition.
  • Develop, review, and maintain project-specific Data Management documents (Data Management Plan, eCRF specifications, Data Validation Plan, external data transfer agreements).
  • Lead and coordinate the development of clinical study database setup, including eCRF design and database validation requirements.
  • Participate in the review of study documents (protocol, Project Plan, safety plans/manuals, statistical analysis plan), lead and coordinate the review of electronic case report forms (eCRFs).
  • Coordinate, oversee, and ensure User Acceptance Testing (UAT) related tasks are successfully completed.
  • Create training materials for EDC users and provide project-specific training as required.
Requirements
  • Lifescience or healthcare degree, and/or combination of education and experience.
  • Minimum 5 years of work experience as Clinical Data Manager.
  • Minimum 5 years of experience in drug development and/or clinical research.
  • Thorough knowledge and understanding of ICH-GCP, 21CFR11 data privacy guidelines, and local/regional requirements.
  • Good understanding of Medical Terminology.
  • Experience with electronic data capture software systems and other tools for managing clinical studies.
  • Experience as DM lead on several studies, preferably in different therapeutic areas and clinical development phases.
Benefits

Allucent offers a comprehensive benefits package, competitive salaries, departmental study/training budget, flexible working hours, remote/hybrid work options, leadership opportunities, internal growth possibilities, career progression, financially rewarding employee referral program, access to online training platforms, Spot Bonus Award Program, and Loyalty Award Program.

In this dynamic role, you will contribute to improving efficiency, develop new skills, and join a collaborative team at Allucent. If you have experience in data management and are passionate about delivering high-quality results, apply now



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