Clinical Data Manager

Summary:

We are seeking a skilled Clinical Data Manager to work closely with vendor Project Managers and Clinical Data Managers to ensure that all Data Management functions are executed in compliance with regulatory standards, study protocols, and the Study Data Management Manual (DMM). This role requires effective collaboration with all parties involved to create and manage the DMM according to company SOPs and in alignment with data standards. As a Clinical Data Manager, you will coordinate, lead, and execute data management activities for assigned studies in line with company policies and practices.

Responsibilities:

In this role, a typical day might include:

• Primary DM Contact: Acting as the main Data Management (DM) contact for assigned studies, including representation on project teams and coordination with CROs responsible for study data management tasks.
• Data Management Coordination: Overseeing clinical data management tasks for assigned studies, including:
  • Monitoring data cleanup performed by CROs from study start-up through data archiving.
  • Providing data for analysis.
  • Coordinating activities such as medical coding, data validation checks, and database snapshots.
• Project Reporting: Preparing and distributing project status reports to project teams and management.
• DM Team Leadership: Leading the DM team in ensuring databases are validated and ready for transfer or analysis in accordance with SOPs.
• Documentation Management: Creating and maintaining essential project documentation, including the Data Management Manual, CRF Completion Guidelines, validation specifications, and work instructions for assigned projects. Designing and modifying CRFs as needed.
• Database Validation: Initiating and approving the building, testing, and validation of clinical databases and managing any subsequent changes or data validation activities.

This Job Might Be for You If You:

• Are passionate about advancing and implementing clinical data platforms.
• Thrive in an innovative, cross-functional team environment.
• Possess strong analytical skills and can collect, organize, analyze, and disseminate large volumes of data with precision.
• Have excellent communication and project management skills.

Qualifications:

To be considered for this role, you must have:

• A bachelor’s degree in Mathematics, Science, or a related field.
• 5+ years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.