Associate Director, CDM Trial Lead, Clinical Data Management

MSD

. Lead end-to-end clinical data management activities for assigned studies from start-up through database lock and archival .

Posted 10/9/2026full-timeBogotá • ColombiaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical data management, including oversight of data collection, validation, and compliance with regulatory standards. Proficient in project management and mentoring, with a strong focus on data quality and integration across clinical trials.

Highest-signal resume keywords

Clinical Data ManagementEDC SystemsCDISC StandardsProject ManagementData Reconciliation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Data ManagementData ValidationData IntegrationQuery ManagementData CleaningRisk ManagementStatistical AnalysisMedical CodingData VisualizationClinical Trial Operations

Soft Skills

CommunicationStakeholder ManagementCollaborationMentoringAdaptability

Tools & Technologies

DHTECOAVendor PortalsDDCUAT DocumentationData Management PlatformsDashboarding ToolsChange-Control Systems

Industry Keywords

Clinical Development LifecycleICH-GCP21 CFR Part 11SOPsPrivacy Requirements

About the role

Key responsibilities & impact

Lead end-to-end clinical data management activities for assigned studies from start-up through database lock and archival
Oversee clinical data collection design, reconciliation, logical consistency review, remediation, validation strategy, and query resolution
Oversee review, validation, and reconciliation of data across clinical trial sources and environments, including DHT, eCOA, external data, vendor portals, EDC, and DDC
Own risk-based data quality oversight, root-cause analysis, mitigation plans, and strategic escalation
Oversee data acquisition, integration, data-flow validation, and data cleaning validation specifications
Integrate specimen and specialty data strategy into the trial data approach and oversee vendor delivery
Ensure protocol-aligned laboratory data setup, normal ranges, documentation, and study-record filing
Oversee development, review, approval, execution, and maintenance of DMP, DVP, eCRFs, specifications, UAT documentation, medical coding plans, database lock documentation, and archival readiness documentation
Own UAT and change-control activities across relevant systems, tools, and data flows
Ensure implementation of CDISC standards and controlled terminology with end-to-end traceability
Ensure compliance with privacy policies, 21 CFR Part 11, sponsor requirements, and health-authority regulations
Represent data management on Clinical Trial Teams and governance forums
Provide oversight, mentoring, and training to Clinical Data Managers and External Data Specialists
Facilitate complex functional and cross-functional meetings and document decisions and action plans
Plan and oversee data management for trials from acquisitions, partnerships, or nonstandard processes
Contribute expertise, project management, and leadership to process, standards, platform, tool, and continuous-improvement initiatives

Requirements

What you’ll need

Non-degree or associate degree with a minimum of 10 years of directly relevant experience in data management, clinical trial operations, or a related field
Bachelor's degree with a minimum of 8 years of experience in data management, clinical trial operations, or a related field
Advanced degree (Master's or Doctorate) with a minimum of 4 years of experience in data management, clinical trial operations, or a related field
Preferred fields include Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology, or Medical Technology
Deep understanding of the clinical development lifecycle, data flow, and cross-functional dependencies
Strong command of clinical data management platforms, EDC systems, data acquisition tools, query management, data reconciliation/integration, and data visualization/dashboarding tools
Extensive experience designing, validating, and maintaining integrated data management deliverables and validation components
Understanding of CDISC standards, including CDASH, SDTM, Define-XML, metadata management, and controlled terminologies
Working knowledge of SOPs, ICH-GCP, 21 CFR Part 11, Annex 11, and privacy requirements
Foundation in clinical practice and medical terminology
Effective project management, planning, execution, and risk management skills
Fluent in English with exceptional communication and influencing skills
Strong stakeholder management and collaboration skills
Independent and accountable work style
Experience facilitating decision-making and coordinating work across teams
Ability to mentor, coach, and share knowledge
High adaptability and resilience
No visa sponsorship available

Benefits

Comp & perks

Regular employee status
No relocation required
No travel required
No visa sponsorship required