Senior Manager, Data Management (LATAM)

Were expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and were 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 >Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.

  Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

  If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.

  It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.