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Precision Medicine GroupSenior Clinical Data Manager
Precision Medicine Group is expanding its operations across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, seeking a remote-based Senior Clinical Data Manager or Principal Clinical Data…
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About This Role
Precision Medicine Group is expanding its operations across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, seeking a remote-based Senior Clinical Data Manager or Principal Clinical Data Manager to establish the foundational LATAM Data Management team. This role manages all aspects of the clinical trial data management process from study start-up through post database lock, ensuring the delivery of high-quality clinical data that supports successful trials and accelerates innovative therapies for…
Job Description
Precision Medicine Group is expanding its operations across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, seeking a remote-based Senior Clinical Data Manager or Principal Clinical Data Manager to establish the foundational LATAM Data Management team. This role manages all aspects of the clinical trial data management process from study start-up through post database lock, ensuring the delivery of high-quality clinical data that supports successful trials and accelerates innovative therapies for patients.
The position suits an experienced data management professional with a broad knowledge of drug, device, and biologic development. Key duties include serving as the primary data management contact for assigned projects, overseeing database development and user acceptance testing, managing timelines, creating edit check specifications, conducting medical coding, and coordinating serious adverse event reconciliation. The professional will also liaise with third-party vendors, train clinical research personnel, and provide leadership for cross-functional initiatives.
Responsibilities
- Serve as the primary data management contact for assigned clinical projects
- Oversee and perform database development, testing, and user acceptance testing
- Develop Case Report Form specifications based on clinical study protocols
- Create and oversee edit check specifications and manual data review specifications
- Manage timelines and assess resource needs to ensure data management deadlines are met
- Train clinical research personnel on study-specific CRF, Electronic Data Capture, and other items
- Review and query clinical trial data and perform line listing data review
- Conduct medical coding to ensure medical logic and consistency
- Coordinate serious adverse event and adverse event reconciliation
- Liaise with third-party vendors such as external data and EDC vendors
- Identify and troubleshoot operational problems using metrics data, audit reports, and team input
Requirements
- 8 plus years of experience for a Senior Clinical Data Manager
- 10 plus years of experience for a Principal Clinical Data Manager
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook
- Experience utilizing various clinical database management systems
- Professional use of the English language in both written and oral forms
- Legal authorization to work in the country of employment without employer sponsorship
Qualifications
- Bachelor's degree and/or a combination of related experience
- Experience in a clinical, scientific, or healthcare discipline
- Dictionary medical coding experience using MedDRA and WHODrug
- Understanding of CDISC standards such as CDASH, SDTM, and ADaM
- Oncology and or Orphan Drug therapeutic experience
Core Skills
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
Is this position remote?
Yes, the source posting indicates that this is a remote role.
What is the salary for this position?
The salary for this position is not stated in the job posting.
What experience is required to apply?
Applicants for the Senior Clinical Data Manager role need eight or more years of experience, while Principal Clinical Data Manager candidates require ten or more years of experience.
Sample Interview Questions
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