Senior Clinical Data Manager/Principal Clinical Data Manager

hace 4 semanas

Alcobendas, Madrid, España Precision Medicine Group A tiempo completo
Job Title: Senior Clinical Data Manager/Principal Clinical Data Manager

Job Summary:

The Senior Clinical Data Manager/Principal Clinical Data Manager is a key member of our team, responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. This role requires strong leadership and organizational skills, as well as expertise in data management and database development.

Key Responsibilities:
  • Lead data management for assigned clinical projects/programs, ensuring timely completion and quality of tasks.
  • Oversee project data entry process, including development of data entry guidelines, training, and quality control.
  • Develop CRF specifications from clinical study protocols and coordinate review/feedback from stakeholders.
  • Conduct database build UAT and maintain quality-controlled database build documentation.
  • Specify requirements for edit checks and oversee development of edit check specifications.
  • Responsible for creating, revising, and maintaining data management documentation.
  • Train clinical research personnel on study-specific CRF, EDC, and other project-related items.
  • Review and query clinical trial data according to the Data Management Plan.
  • Perform line listing data review and run patient and study level status and metric reporting.
  • Liaise with third-party vendors and coordinate SAE/AE reconciliation.
  • May assist with SAS programming and quality control of SAS programs.
  • Identify and troubleshoot operational problems and issues for studies.
Requirements:
  • Bachelor's degree and/or related experience.
  • Minimum 2 years of experience as a Lead Data Manager for a Clinical Research Organisation.
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
  • Excellent organizational and communication skills.
  • Professional use of the English language; both written and oral.
  • Experience in utilizing various clinical database management systems.
  • Broad knowledge of drug, device, and/or biologic development and effective data management practices.

About Precision Medicine Group:

Precision Medicine Group is a leading provider of clinical research services, dedicated to delivering high-quality data management solutions to the pharmaceutical and biotechnology industries.

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