Clinical Data Manager

Summary:

Clinical Data Manager, where you'll collaborate with vendor Project Managers and Clinical Data Managers to oversee data management activities that comply with regulations, study protocols, and internal standards. This position offers the opportunity to lead, coordinate, and contribute to the success of clinical studies at every stage of development.

Responsibilities:

• Serve as the primary Data Management (DM) contact for assigned studies, representing DM on project teams and managing relationships with Contract Research Organizations (CROs).
• Coordinate and execute clinical data management activities throughout study lifecycles, ensuring adherence to SOPs and data standards.
• Monitor data cleanup activities performed by CROs, from study startup through data archiving.
• Oversee key processes, including medical coding, data validation checks, and database snapshots.
• Prepare and distribute project status reports to project teams and management.
• Lead DM teams to ensure databases are validated, accurate, and ready for transfer and analysis in line with company SOPs.
• Develop and maintain essential project documentation, such as the Data Management Manual, CRF Completion Guidelines, and validation specifications.
• Design and modify case report forms (CRFs) to meet study needs.
• Initiate, approve, and manage the building, testing, and validation of clinical databases, ensuring seamless integration of updates and validation activities.

Requirements:

• Bachelor’s degree in Mathematics, Science, or a related field.
• A minimum of 3 years of clinical data management experience in the biotechnology, pharmaceutical, or health-related industry.
• Previous experience in hematology or oncology is a plus.
• Are passionate about implementing and championing clinical data platforms.
• Thrive in an innovative, collaborative, and multi-functional team environment.
• Excel at analyzing and organizing large datasets with exceptional attention to detail and accuracy.
• Bring outstanding communication and project management skills to the table.