Clinical Data Management Sr. Specialist

MSD Malaysia; Bogotá; Híbrido; COP 120.000.000 - 170.000.000; Jornada completa

Descripción de la vacante

MSD Malaysia is seeking a Clinical Data Manager (SCDM) to drive end-to-end data management for clinical trials, including tool development, validation, and data quality assurance. The role emphasizes compliance with SOPs and ICH-GCP, with exposure to RBQM and AI-enabled capabilities.

The candidate should have 1+ year in clinical data management, with a strong foundation in data integrity, query management, and cross-functional collaboration in a hybrid work environment.

Formación

• Bachelor's degree or higher in life sciences, computer science, or related field with 1+ year in clinical data management.
• Associates degree with 2+ years’ experience in clinical data management.
• High school diploma with 3+ years’ experience in clinical data management.

Responsabilidades

• Execute end-to-end data management activities for clinical trials.
• Develop, validate, and maintain data management tools and systems.
• Prepare and execute database lock and data reconciliation tasks.
• Ensure compliance with SOPs and ICH-GCP guidelines.

Conocimientos

Clinical Data Management

Data Validation

EDC

Data Quality Assurance

Data Analysis

Regulatory Compliance

Educación

B.A./B.S. in life science or related field

Associate's Degree in clinical data management

High School Diploma with relevant experience

Herramientas

CDMS (Clinical Data Management Systems)

RBQM tooling

SQL/Database skills

Descripción del empleo

Job Description

Under the direction of the applicable management, the Clinical Data Manager (SCDM) is responsible for executing end-to-end data management activities pertaining to clinical trials, including but not limited to data management tool and system development, validation and maintenance, data integrity review and reconciliation, query management, and database lock preparation/execution, in compliance with Company Standard Operating Procedures (SOPs) and ICH-GCP guidelines. The role also looks for candidates with relevant experience in adjacent clinical, monitoring, operational, or technology areas, particularly where such experience strengthens the organization’s ability to support RBQM, AI-enabled capabilities, medical monitoring, site monitoring, and SDV-related needs. In Early Stage Development (ESD), the SCDM may have sole responsibility for these activities; in Late Stage Development (LSD), the SCDM’s execution of these activities may be overseen by a Lead Clinical Data Manager (LCDM) or other manager.

Education and Experience

• At least B.A. or B.S. degree, preferably in life science, computer science, or health care related discipline with at least 1 year professional experience in clinical data management
• OR Associates Degree with at least 2 years’ professional experience in clinical data management
• OR High School Diploma (or equivalent) with at least 3 years’ professional experience in clinical data management

Preferable knowledge and skills

Highly self‑driven, with advanced expertise in work planning, prioritization, and time management. Fluent professional English, written and spoken, for global and cross‑functional collaboration. Strong end‑to‑end understanding of the clinical development lifecycle. Advanced knowledge of clinical practice and precise use of medical terminology. Solid command of regulatory frameworks, SOPs, and compliance requirements. Proven ability to perform under pressure in fast‑paced, changing environments. Clear and effective communicator across technical, clinical, and business stakeholders. Demonstrated leadership and decision‑making contribution, with confidence to challenge and influence. Hands‑on expertise in Data Validation component design and development. Proven capability to translate protocol requirements into high‑quality Data Management specifications.

AND for External Candidates

Relevant experience in adjacent clinical, monitoring, operational, or technology roles such as CRA, CSSM, or IT. Working knowledge of RBQM, AI-enabled capabilities, medical monitoring, site monitoring, and SDV. Ability to apply cross‑functional experience to strengthen data quality, risk oversight, and stakeholder collaboration. -Fluent oral and written English skills.

Required Skills

Adaptability, Adaptability, Clinical Analytics, Clinical Data Cleaning, Clinical Data Management, Clinical Development, Clinical Reporting, Clinical Research, Communication, Competency Management, Customer-Focused, Data Analysis, Database Development, Data Management, Data Processing, Data Quality Assurance, Data Review, Data Standards, Data Validation, Data Visualization, Decision Making, Early Phase Clinical Trials, Electronic Data Capture (EDC), Learning Agility, Pharmacovigilance {+ 8 more}

Employee Status

• 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): NA

Job Posting End Date

Job Posting End Date: 09/30/2026 *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.

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.