Sr. Clinical Data Manager

Summary

The job involves leading data management activities for assigned projects, ensuring data integrity, validity, and reliability. The employee will act as a coach, mentor, or Subject Matter Expert within the department. The position requires a minimum of one to two years post-secondary certification in a relevant field and 3-5 years of related work experience in Clinical Data Management with ongoing training. The job is home-based and offers a salary between €54,500 - €91,000 per year plus bonus.

Requirements

• A minimum of a one to two year post-secondary certification in a relevant field of study
• 3-5 years of related work experience in Clinical Data Management with ongoing training

Responsibilities

• Lead, plan, and execute all data management activities for assigned projects
• Ensure focus on data integrity, validity, reliability in accordance with standard processes, sponsor guidelines, industry best practices, and regulatory standards
• Serve as the Lead Data Manager and primary contact responsible for overseeing day-to-day data management activities
• Create and maintain the Data Management Plan
• Development and design of Case Report Forms (CRFs)
• Develop Database Build specifications and coordinate database build and testing activities with database programmers
• Define and test edit checks
• Perform data review and query generation/resolution
• Track study progress and issue periodic status reports
• Process/reconcile electronic data received from other data sources, e.g. CIMS, Safety database, labs, IRT
• Oversee database lock and transfer process
• Coordinate and supervise the day-day work of Data Management (DM) staff assigned
• Train and mentor assigned employees on data management procedures and guidelines
• Participate/lead internal/sponsor meetings as required, working directly with the assigned project manager and team to provide data management support
• Ensure approved study documentation is maintained and properly stored in the trial master files
• Manage project resources per budget and within expected timeframes
• Develop or assist with the project training development and delivery, for investigators, clinical sites, project teams and sponsors on data collection processes, tools and/or equipment as required
• Act as point of escalation for data related issues and queries

Preferred Qualifications

CCDM designation is considered an asset

Benefits

• Home-based
• ���54,500 - €91,000 a year
• + bonus