Clinical Data Management Associate Specialist

MSD LATAM; Tandil; Híbrido; ARS 83.301.000 - 128.737.000; Jornada completa

Descripción de la vacante

MSD LATAM is seeking an Associate Specialist, Clinical Data Management to execute core data management activities for assigned trials under supervision, ensuring data quality, integrity, and audit readiness across diverse data sources.

You will support data review, reconciliation, query management, and documentation, contribute to study-level artifacts, and collaborate with cross-functional teams in a hybrid work environment in LATAM.

Formación

• Minimum 2 years in data management or clinical trial operations.
• Associate’s Degree preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with minimum 1 year of experience.
• Bachelor's Degree preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with prior experience.
• Advanced Degree preferred in related fields.

Responsabilidades

• Execute core data management activities per SOPs, ICH-GCP, and protocol requirements under supervision.
• Support data review, reconciliation, and query management with sites and providers.
• Review, validate, and reconcile data from multiple sources and environments (EDC, DDC, eCOA).
• Identify data quality issues and escalate to leadership with context.
• Support specimen and specialty data workflows from acquisition to results availability.
• Verify protocol-aligned lab data setup and documentation in the study records.
• Contribute to study documentation (DMP, DVP, eCRF guidelines) and audit readiness.
• Assist with UAT execution and change control across the study lifecycle.
• Collaborate with the data management team and stakeholders to meet timelines.
• Support continuous improvement projects.

Conocimientos

Data management

Data validation

Audit trails

Collaboration

Regulatory compliance

Educación

Non-Degree with 2+ years experience

Associate Degree in Life Sciences/Health

Bachelor's Degree in Life Sciences/IT

Advanced Degree (MS/PhD)

Herramientas

EDC systems

SQL basics

eCRF data

Descripción del empleo

Job Description

Under the direction of senior staff, the Associate Specialist, Clinical Data Management executes core data management activities for assigned trials in accordance with protocols, SOPs, and regulatory requirements. The role supports data entry, validation, reconciliation, query management, and documentation to ensure data quality and audit readiness, contributing to end-to-end study delivery.

Responsibilities

• Execute clinical data management activities for assigned studies in accordance with defined processes, timelines, quality targets, Standard Operating Procedures (SOPs), International Council for Harmonization – Good Clinical Practice (ICH-GCP), and protocol-specific requirements, working under routine supervision from assigned leadership.
• Support clinical data review—defined as reconciliation, logical consistency review, and remediation of study data from multiple sources and data types. Support query management to clinical sites and service providers through resolution in collaboration and alignment with Site Monitoring and Medical Monitoring.
• Review, validate, and reconcile data within and across clinical trial data sources and environments, which may include (but not limited to) digital health technologies (DHT), electronic clinical outcome assessments (eCOA), electronic external data (e.g., central laboratories, imaging, biomarkers), vendor/service provider portals, and the clinical database including site entered or transferred data (e.g., EDC [Electronic Data Capture] or DDC [Direct Data Capture]), ensuring data completeness, consistency, and integrity.
• Identify and raise potential data quality issues and risks (e.g., recurring queries, inconsistent data, missing data, late vendor transfers), escalating to assigned leadership with supporting context.
• Support specimen and specialty data workflows (as applicable), including tracking and reconciliation for samples, images, and other patient specimens from acquisition through results availability, ensuring appropriate documentation, follow-through, and traceability.
• Support verification of protocol-aligned laboratory data setup, including confirmation that laboratories apply protocol-appropriate normal ranges; ensure documentation is filed within the study record.
• Contribute to study-level documentation under direction of assigned leadership, including (but not limited to) the Data Management Plan (DMP), Data Validation Plan (DVP), edit check specifications, and electronic case report form (eCRF) completion guidelines/annotations (or equivalent specifications for other modalities), maintaining complete and traceable records to support audit and inspection readiness.
• Assist with User Acceptance Testing (UAT) execution and documentation and support change control activities across the study lifecycle.
• Collaborate and communicate effectively with the clinical data management team and assigned stakeholders to align priorities, resolve issues within agreed timelines, and close feedback loops to support coordinated, high-quality delivery.
• Support additional projects and continuous improvement initiatives as assigned.

Technical Skills

• Basic knowledge of data collection, analysis, trending and summarization in a research or medical setting.
• Basic understanding of relational database concepts (e.g., tables, keys, data types)
• Preferred Experience in data management, medical research, and/or database design or development.

Non-technical Skills

• Prioritize assigned tasks, meet deadlines, and maintain accurate documentation.
• Strong attention to detail; follow procedures and data privacy/compliance requirements.
• Provide clear, timely updates; ask clarifying questions; document concise notes and status.
• Use basic structured thinking to address issues; elevate appropriately.
• Build positive, professional, inclusive working relationships with peers, leadership, cross-functional partners, and service providers.
• Demonstrate reliability and openness to guidance; incorporate feedback quickly.

Enterprise Leadership Skills

• Networking & Partnerships | Develop effective working relationships across teams to support collaboration, coordinate activities, and achieve shared goals.
• Execution Excellence | Take timely action to accomplish work goals in line with compliance standards, while demonstrating initiative and a proactive approach to achieving results.
• Ownership & Accountability | Take ownership of assignments, maintain high standards for quality and performance, and accountable for completing work effectively and reliably.

Qualifications & Experience

• Non-Degree with minimum 2 years of experience in data management, clinical trial operations, or a related field
• Associate’s Degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology) with minimum 1 year of experience working in data management or clinical trial operations or related field.
• Bachelor's Degree (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology, or equivalent education experience) with prior experience working in data management or clinical trial operations or related field preferred.
• Advanced Degree (Masters or Doctorate) (preferred in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology)

Required Skills

Adaptability, Adaptability, Analytical Problem Solving, Audit Trails, Clinical Data Cleaning, Clinical Data Management, Constructive Feedback, Data Analysis, Data Auditing, Data Capturing, Data Documentation, Data Entry, Data Integrity, Data Processing, Data Reporting, Data Review, Data Validation, Data Visualization, Documentation Preparation, Document Management, Enterprise Leadership, Goal Attainment, Good Clinical Practice (GCP), Organizational Leadership, Proactive Thinking {+ 9 more}

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

no

Job Posting End Date

10/31/2026

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID R423304