Senior Clinical Data Manager

Overview

• Lead clinical data management processes for remote projects, ensuring compliance with industry standards and regulations.
• Collaborate with cross-functional teams and vendors to optimize data workflows and achieve project objectives.
• Develop and maintain data management plans, ensuring accuracy and efficiency in clinical studies.
• Oversee database development, user acceptance testing, and data cleaning activities.
• Ensure compliance with FDA, Health Canada, and ICH GCP guidelines in all data management processes.
• Contribute to the development and improvement of standard operating procedures and workflows.
• Provide expertise in electronic data capture technologies and industry standards like CDISC and SDTM.
• Support the archiving of study databases and related documentation for future reference.

Key Responsibilities & Duties

• Manage clinical data timelines and metrics, ensuring project deliverables are met.
• Select and oversee data management vendors, ensuring quality and compliance.
• Coordinate user acceptance testing and approve electronic data capture databases.
• Develop and manage data transfer agreements between external vendors and core labs.
• Collaborate on the development of case report forms and approve final versions.
• Oversee the creation of edit checks and ensure their accuracy and functionality.
• Lead data cleaning activities and ensure data integrity throughout the study.
• Participate in the review of clinical documents, including protocols and statistical analysis plans.
• Write and update standard operating procedures to enhance data management processes.

Job Requirements

• Bachelor’s or Master’s degree in a relevant field, with seven or more years of clinical data management experience.
• Proficiency in electronic data capture technologies such as RAVE and INFORM.
• Knowledge of industry standards like CDISC, SDTM, and CDASH.
• Certification in data management is preferred; experience in CNS studies is advantageous.
• Strong organizational skills and attention to detail, with excellent communication abilities.
• Understanding of FDA, Health Canada, and ICH GCP guidelines governing clinical research.
• Proficiency in Microsoft Office tools, including Word, Outlook, and Excel.
• Ability to forecast and manage budgets effectively.
• Experience in writing and improving standard operating procedures for data management.