Senior Clinical Data Manager (Mexico)

About the Role

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Clinical Data Manager to help build the foundation of our clinical data operations in Mexico.

Job Description

The Senior Clinical Data Manager is responsible and manages all aspects of the clinical trial data management process from study start up to post database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines to be followed. This position will also oversee and/or perform database development and testing.

Essential Functions

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) /program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs
• Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
• Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May assist in building clinical databases
• Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
• Oversee development of the edit check specifications and manual data review specifications
• Responsible for creating, revising, appropriate versioning and maintaining data management documentation
• Oversee completeness of data management documentation for the Trial Master File
• Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
• Review and query clinical trial data according to the Data Management Plan
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM
• Run patient and study level status and metric reporting
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
• Coordinate SAE/AE reconciliation
• Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables