Senior Manager, Data Management (LATAM)

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru , and we’re hiring a Senior Manager of Data Management in Mexico! In this role, you will manage the day-to-day activities of the Data Management (DM) function in accordance with Standard Operating Procedures (SOPs), regulatory directives, and study-specific plans, with an emphasis on effective resourcing and development of personnel. The Senior Manager is responsible for the successful planning, implementation, and execution of DM contracted activities. The Senior Manager provides oversight, leads activities for data management projects, and coordinates inter-departmental and client communication. This person will support the Head of Department in the development of functional training, hiring, definition of standards, and execution of department goals including process improvement. 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 corresponding process documentation related to data management and database management activities May be a subject matter expert in one or more DM/system topics, creating training on the SOPs/processes Provides technical and operational guidance and direction, checking output of project work, ensuring deliverables are me