Remote opportunity at
pfm medical, inc.Senior Clinical Data Manager
pfm medical, inc. is expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and is currently seeking a Senior Clinical Data Manager to help establish its…
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About This Role
pfm medical, inc. is expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and is currently seeking a Senior Clinical Data Manager to help establish its growing Latin America data management team. This remote role is responsible for overseeing all phases of the clinical trial data lifecycle, ranging from study start-up through post-database lock, in strict alignment with regulatory requirements and standard operating procedures. The ideal candidate will serve as…
Job Description
pfm medical, inc. is expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and is currently seeking a Senior Clinical Data Manager to help establish its growing Latin America data management team. This remote role is responsible for overseeing all phases of the clinical trial data lifecycle, ranging from study start-up through post-database lock, in strict alignment with regulatory requirements and standard operating procedures. The ideal candidate will serve as the primary data management contact for assigned programs, lead database development and user acceptance testing, manage timelines, and ensure high-quality data deliverables.
The position involves coordinating data entry guidelines, specifying edit checks, performing data reviews, handling medical coding, and managing serious adverse event reconciliations. Professionals in this role will also liaise with external vendors, collaborate with cross-functional project teams, and provide mentorship or training to junior personnel. This opportunity suits experienced clinical research professionals with extensive background in data management who can lead complex projects and support innovative therapeutic research.
Responsibilities
- Serve as the primary data management lead for assigned clinical projects to guarantee timely and responsive task execution
- Oversee data entry processes, develop data entry guidelines, conduct quality control, and assess resource needs
- Design case report form specifications based on study protocols and gather feedback from stakeholders
- Conduct database build user acceptance testing and preserve documentation quality control
- Specify and develop edit check requirements and manual data review parameters
- Train clinical research personnel on study-specific data collection tools and electronic data capture systems
- Examine trial data, run metrics reports, and perform medical coding to maintain consistency
- Coordinate serious adverse event and adverse event reconciliations
- Collaborate with third-party vendors and external data providers to support project timelines
- Contribute to the creation and maintenance of standard operating procedures and data management documentation
Requirements
- Minimum of eight years of relevant experience for a senior clinical data manager
- Proficiency in Microsoft Office applications including Word, Excel, PowerPoint, and Outlook
- Familiarity with various clinical database management systems
- Comprehensive knowledge of effective data management practices within drug, device, or biologic development
- Professional written and verbal communication skills in English
- Legal authorization to work in the country of employment without requiring sponsorship
Qualifications
- Bachelor's degree and/or an equivalent combination of related experience
- Background in a clinical, scientific, or healthcare discipline
- Training in dictionary medical coding tools such as MedDRA and WHODrug
- Familiarity with Clinical Data Interchange Standards Consortium standards like CDASH, SDTM, and ADaM
- Therapeutic experience in oncology and/or orphan drugs
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 posting indicates that the role is remote.
What is the employment type?
The position is full-time.
What experience is required for the Senior Clinical Data Manager role?
Candidates must have at least eight years of relevant experience for the senior level.
What salary is offered for this job?
The salary is not stated in the source posting.
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