Senior Clinical Data Manager

Clinical Outcomes Solutions

. Lead or support data management study activities, CRO oversight, and deliverable timelines .

Posted 9/24/2026full-timeRemote • ColombiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Data Management, ensuring compliance with FDA and ICH regulations while managing data quality and deliverables across cross-functional teams. Proficient in overseeing EDC systems and preparing for submission readiness and audits.

Highest-signal resume keywords

Clinical Data ManagementEDC Systems OversightFDA Regulations KnowledgeICH Regulations KnowledgeCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data Management Best PracticesClinical Trial Documents UnderstandingStatistical Analysis PlansStudy ReportsCRFsData Quality ManagementBudget ManagementProcess ImprovementMetrics PreparationSubmission Readiness

Soft Skills

CollaborationRisk MitigationStakeholder ManagementProblem SolvingCommunication

Industry Keywords

CRO OversightTherapeutic AreasGXP RequirementsSCDMCDISCDIAData Management Trial Master FileContinuous Improvement InitiativesOperational ModelsLearning Curricula Compliance

About the role

Key responsibilities & impact

Lead or support data management study activities, CRO oversight, and deliverable timelines
Build and oversee EDC systems
Represent data management on Clinical Sub-teams and align CRO and client expectations for data-related deliverables
Collaborate with client stakeholders to meet milestones and deliverables with high quality
Partner with stakeholders and CROs to mitigate and resolve risks
Provide input to functional governance with strategic suppliers and resolve escalated issues
Prepare the function for submission readiness and represent it in inspections or audits
Ensure archival and inspection readiness of Data Management Trial Master File documents
Coordinate data management deliverables and milestones with Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics
Plan and manage external Data Management budgets and timelines, analyze variances, and improve forecasting
Act as a process expert for operational and oversight models
Maintain SOPs, process maps, templates, and timelines
Prepare metrics supporting functional KPIs
Represent the function in external professional initiatives and organizations such as SCDM, CDISC, and DIA
Contribute strategic direction to continuous improvement initiatives
Ensure compliance with learning curricula, corporate, and GXP requirements
Work cross-functionally to ensure database data quality, on-time delivery, and quality of other data management deliverables

Requirements

What you’ll need

Bachelor's Degree in a science, health related, or information technology field required
Minimum 5 years experience in Clinical Data Management
Experience with all phases of development in one or more therapeutic areas preferred
Strong knowledge of data management best practices and technologies as applied to clinical trials
Solid understanding of clinical trial documents, including protocols, statistical analysis plans, CRFs, and study reports
Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes
Strong knowledge of the broad drug development process
Expertise in cross-functional interfaces with the data management function

Benefits

Comp & perks

Professional growth opportunities
Work fully embedded within a pharmaceutical client program
Autonomy and ownership in the role