Senior Manager, Data Management (LATAM)

Essential functions of the job include but are not limited to:

• Supports the DM Lead as the point of contact for internal team and sponsor, ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner for all studies for clients, which may include DM oversight of sponsor programs
• Line manages, directs, leads, develops, and supervises data managers
• Support the LDM in the management of contractual and financial aspects of project
• Reviews Request for Proposals (RFP), proposals, change orders, and provide project estimates
• Oversees project data entry process for paper studies, including development of data entry guidelines, training, data entry quality and resourcing
• Ensure DM adheres to project timelines. Provides input, assesses, and may manage timelines. Ensures that clinical data management deliverables are met with quality
• Assesses resource needs for assigned projects, as needed
• Ensures the DM Leads successfully plans, organizes, and coordinates data management (DM) activities in a set of projects belonging to one or more clients, meeting quality, timelines, and budget expectations
• Accountable for ensuring all data quality and timeliness of DM deliverables are met and aligned with the business goals
• May develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders
• May conduct database build UAT and maintain quality controlled database build documentation
• Oversees overall quality of the clinical database
• May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc.
• Oversees completeness of data management documentation for the Trial Master File
• May train clinical research personnel on the study specific CRF, EDC, and other project related items as needed
• May run patient and study level status and metric reporting. Oversee the development requirements and frequency of report delivery
• May coordinate SAE/AE reconciliation
• May liaise with third-party vendors, such as external data and EDC vendors, in a project-manager capacity in support of timelines and data-related deliverables
• May partner with cross-functional stakeholders to meet project deliverables and timelines for clinical data acquisition, quality checking, and reporting and serving as an internal expert on data management/RBQM with vendors
• Develops and supports customer relationships, manages customer expectations, and flags/escalates risks as required
• Identifies, troubleshoots and strategizes operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• Participates in the development and maintenance of Standard Operating Procedures (SOPs) and co