Clinical Data Manager (Ciudad de México)

Clinical Data Manager (Ciudad de México)

31 oct
|
Precision For Medicine
|
Ciudad de México

31 oct

Precision For Medicine

Ciudad de México

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.
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. This position will also oversee and/or perform database development and testing.
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. Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing
May perform quality control of data entry
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
Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency
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 review Request for Proposals (RFP), proposals, provide project estimates




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
Bachelors and/or a combination of related experience

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
~ Professional use of the English language; 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
~ Experience in a clinical, scientific or healthcare discipline
Dictionary medical coding (MedDRA and WHODrug)
Oncology and/or Orphan Drug therapeutic experience
#LI-REMOTE
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📌 Clinical Data Manager (Ciudad de México)
🏢 Precision For Medicine
📍 Ciudad de México

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