James Meiss

Responsible for all data management activities, ensuring data integrity, quality, and timeliness. Provided development input into all CRO generated CDM documentation and ensured projects adhered to global harmonized SOPs and GCPs.

Collaborated with Lead Data Manager on studies, performing data operational tasks including data review and query management to achieve quality standards. Assisted in building study milestone timelines and supported the training of new staff on project-specific processes.

Performed aggregate review of clinical data to identify trends and inconsistencies, generating and resolving queries to address problematic data. Applied quality control procedures and assisted with the development of Global Data Management Plans and Quality Management Plans.

Reviewed clinical trial data to identify erroneous or incomplete information, generating and resolving queries to correct the database. Performed reconciliation of clinical and safety databases, and assisted with the development of Global Data Management Plans.

Ensured electronic vendor data conformed to protocol specifications and correct formatting, developing Data Transfer Agreements and Specifications. Reviewed data discrepancies from edit checks and performed query management to resolve data issues.

Developed Data Transfer Agreements and Specifications for vendor data transfers, creating and validating edit checks for external data types. Reviewed data discrepancies and performed query management, while also managing external data status reports.

Studied the principles and practices of journalism, including reporting, writing, editing, and media ethics. Gained foundational knowledge in various forms of media communication and storytelling.