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 programsLine manages, directs, leads, develops, and supervises data managersSupport the LDM in the management of contractual and financial aspects of projectReviews Request for Proposals (RFP), proposals, change orders, and provide project estimatesOversees project data entry process for paper studies, including development of data entry guidelines, training, data entry quality and resourcingEnsure DM adheres to project timelines. Provides input, assesses, and may manage timelines. Ensures that clinical data management deliverables are met with qualityAssesses resource needs for assigned projects, as neededEnsures 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 expectationsAccountable for ensuring all data quality and timeliness of DM deliverables are met and aligned with the business goalsMay develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholdersMay conduct database build UAT and maintain quality controlled database build documentationOversees overall quality of the clinical databaseMay 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 FileMay train clinical research personnel on the study specific CRF, EDC, and other project related items as neededMay run patient and study level status and metric reporting. Oversee the development requirements and frequency of report deliveryMay coordinate SAE/AE reconciliationMay liaise with third-party vendors, such as external data and EDC vendors, in a project-manager capacity in support of timelines and data-related deliverablesMay 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 vendorsDevelops and supports customer relationships, manages customer expectations, and flags/escalates risks as requiredIdentifies, 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 stakeholdersParticipates in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activitiesMay be a subject matter expert in one or more DM/system topics, creating training on the SOPs/processesProvides technical and operational guidance and direction, checking output of project work, ensuring deliverables are met and performance and professional behavior reflect PfM principalsResponsible for managing, leading, and mentoring staff. Collects timely feedback and conducts performance evaluations. Participates in the interview process for new recruitsSupports Business Development teams by attending strategy meetings, bid defense preparation meetings, bid defenses, capability presentations, potential client engagement, professional meetings or seminarsReviews Request for Proposals (RFP), proposals, provide project estimatesProvides leadership for cross-functional and organization-wide initiatives, where applicableEnsures that all data management project team members have been sufficiently trainedCommunicates with sponsors, vendors and global project teams as needed regarding data, database or other relevant project issues, and is responsible for developing, maintaining, managing, and meeting client expectationsMay present software demonstrations/trainings, department/company training sessions, and presents at project mee