We're expanding across **Mexico, Brazil, Argentina, Colombia, Chile**, and **Peru**, and we're looking for an experienced Clinical Data Manager to help build the foundation of our growing LATAM Data Management team, ensuring the delivery of high-quality clinical data that drives successful clinical trials and accelerates innovative therapies to patients.
**Position Summary**:The Senior Clinical Data Manager/Principal 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 will be followed.This position will also oversee and/or perform database development and testing.
**Essential functions of the job include but are not limited to**:- 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- May perform quality control of data entry- 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- May assist with SAS programming and quality control of SAS programs used in the Data Management department- Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders- May assist in reviewing and providing feedback on protocols,



Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project- Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities- May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings- May review Request for Proposals (RFP), proposals, provide project estimates- Provide leadership for cross-functional and organization-wide initiatives, where applicable- Trains and ensures that all data management project team members have been sufficiently trained- Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues- May present software demonstrations/trainings, department/company training sessions, present at project meetings- May require some travel- Perform other duties as assigned**Qualifications**:Minimum Required:- Bachelors and/or a combination of related experienceOther Required:- **8+ years' experience for a Sr.Clinical Data Manager and 10+ years for a Principal Clinical Data Manager**:- Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook- Able to handle a variety of clinical research tasks- Excellent organizational and communication skills- Professional use of the English language; both written and oral- **Experience in utilizing various clinical database management systems**:- Broad knowledge of drug, device and/or biologic development and effective data management practices- Strong representational skills, ability to communicate effectively orally and in writing- Strong leadershi

📌 Clinical Data Manager (Xico)
🏢 Precision For Medicine
📍 Xico