Clinical Data Management Sr. Specialist

MSD; Guaduas; Híbrido; COP 217.980.000 - 342.540.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Competitive benefits

Descripción de la vacante

MSD in Colombia seeks a Senior Clinical Data Manager to lead end-to-end data management activities for clinical trials, ensuring data integrity and database locks in support of RBQM and AI-enabled capabilities. Role requires English proficiency and strong regulatory knowledge.

The candidate will translate protocol requirements into robust data management specifications and collaborate across clinical, monitoring, and IT functions in a hybrid work environment.

Formación

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

Responsabilidades

• Execute end-to-end clinical data management activities including data management system development and validation.
• Ensure data integrity, reconcile data, manage queries, and prepare database locks.
• Support RBQM, AI-enabled capabilities, medical monitoring, and SDV needs.
• Translate protocol requirements into high-quality data management specifications.

Conocimientos

Clinical Analytics

Data Validation

Electronic Data Capture

Regulatory Compliance

Cross-functional Collaboration

Educación

Bachelor's degree in life sciences

Associates Degree

High School Diploma

Descripción del empleo

Job Description

Under the direction of the applicable management, the Senior 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}

Preferred Skills:

• 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: 09/29/2026
• *A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.