Senior Clinical Data Manager

Precision Medicine Group

. Serve as the primary Data Management contact for assigned clinical projects/programs, ensuring continuity, responsiveness, backup coverage, and timely task completion .

Posted 10/27/2026full-timeRemote • Mexico, Brazil, ColombiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Data Management, including proficiency in database management systems, SAS programming, and adherence to data management practices. Strong leadership and communication skills are essential for managing cross-functional teams and engaging with stakeholders effectively.

Highest-signal resume keywords

Clinical Data ManagementSAS ProgrammingDatabase Management SystemsLeadership SkillsCDISC Standards

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data ManagementMedical CodingCRF SpecificationsData Entry ProcessesQuality ControlData ReviewTrial Master File ManagementDatabase Build User Acceptance TestingEdit-Check RequirementsMetric Reporting

Soft Skills

Organizational SkillsCommunication SkillsInterpersonal SkillsRepresentational SkillsTraining Skills

Tools & Technologies

Microsoft OfficeEDC SystemsClinical Database Management Systems

Industry Keywords

Clinical ResearchDrug DevelopmentBiologic DevelopmentOncology ExperienceOrphan Drug ExperienceMedDRAWHODrugCDASHSDTMADaM

About the role

Key responsibilities & impact

Serve as the primary Data Management contact for assigned clinical projects/programs, ensuring continuity, responsiveness, backup coverage, and timely task completion
Oversee project data entry processes, including data entry guidelines, training, quality, and resourcing
Provide input on and manage timelines, deadlines, and resource needs
Develop CRF specifications from clinical study protocols and coordinate stakeholder review
Assist with clinical database builds and conduct database build user acceptance testing
Maintain quality-controlled database build documentation and oversee clinical database quality
Specify and oversee edit-check and manual data-review requirements
Create, revise, version, and maintain data management documentation and Trial Master File completeness
Train clinical research personnel and data management project team members on CRFs, EDC, and project-related items
Review and query clinical trial data according to the Data Management Plan
Perform line-listing data review and patient- and study-level status and metric reporting
Perform medical coding and coordinate SAE/AE reconciliation
Liaise with external data and EDC vendors regarding timelines and data-related deliverables
Assist with SAS programming and quality control of SAS programs
Identify and troubleshoot operational problems using metrics, audit reports, and stakeholder input
Review and provide feedback on protocols, SAPs, and CSRs when required
Participate in development and maintenance of SOPs and process documentation
Support strategy meetings, bid defenses, capability presentations, client engagement meetings, RFP reviews, proposals, and project estimates as needed
Provide leadership for cross-functional and organization-wide initiatives
Communicate with sponsors, vendors, and project teams regarding data, database, and project issues
Present software demonstrations, trainings, and project meetings
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree and/or a combination of related experience
8+ years’ experience for a Senior Clinical Data Manager; 10+ years for a Principal Clinical Data Manager
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook
Ability to handle a variety of clinical research tasks
Excellent organizational and communication skills
Professional use of the English language, written and oral
Experience utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices
Strong representational skills and ability to communicate effectively orally and in writing
Strong leadership and interpersonal skills
Ability to undertake occasional travel
Candidates must be legally authorized to work in the country of employment without employer sponsorship
Preferred: experience in a clinical, scientific or healthcare discipline
Preferred: dictionary medical coding (MedDRA and WHODrug)
Preferred: understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
Preferred: oncology and/or orphan drug therapeutic experience

Benefits

Comp & perks

May require some travel
Equal Opportunity Employer
Reasonable accommodation available for the application process
AI-generated insights may be used during the application journey, with an opt-out option