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Senior Clinical Data Manager/Principal Clinical Data Manager

hace 2 meses


Alcobendas, Madrid, España Precision Medicine Group A tiempo completo
Job Summary

The Senior Clinical Data Manager/Principal Clinical Data Manager is a key member of our team at Precision Medicine Group, responsible for overseeing all aspects of clinical trial data management. This role involves managing the data management process from study start-up to post-database lock, ensuring compliance with regulatory directives and standard operating procedures.

Key Responsibilities
  • Lead Data Management: Serve as the primary data management contact for assigned clinical projects, ensuring timely and quality delivery of data management tasks.
  • Database Development: Oversee the development and testing of clinical databases, ensuring data quality and integrity.
  • Quality Control: Perform quality control of data entry and ensure that clinical data management deadlines are met.
  • Project Management: Assess resource needs, develop project timelines, and ensure that clinical data management deadlines are met.
  • Documentation: Create, revise, and maintain data management documentation, including data management plans and trial master files.
  • Training and Communication: Train clinical research personnel on study-specific CRFs, EDC, and other project-related items, and communicate with study sponsors, vendors, and project teams as needed.
Requirements
  • Education: Bachelor's degree and/or a combination of related experience.
  • Experience: Minimum 2 years of experience as a Lead Data Manager for a Clinical Research Organisation.
  • Skills: Proficiency in Microsoft Office, excellent organizational and communication skills, and professional use of the English language.
  • Preferred Qualifications: Experience in a clinical, scientific, or healthcare discipline, dictionary medical coding, and understanding of CDISC standards.
What We Offer

At Precision Medicine Group, we offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.