Clinical Data Manager - FSP

Parexel; Colombia; Presencial; COP 200.836.819 - 301.255.229; Jornada completa

Descripción de la vacante

Parexel is hiring Clinical Data Manager positions in Colombia, with opportunities across Latin America. The role focuses on planning and executing Data Management activities for PH1-4 studies, coordinating with CROs and internal teams, and ensuring high data quality under Parexel standards.

The candidate should have 2+ years in pharma/biotech Data Management, familiarity with ICH-GCP, CDISC, and strong English communication. Bachelor’s degree is required, Master’s preferred.

Formación

• At least two years’ experience in Data Management in pharma/biotech.
• Understanding of regulatory guidelines (ICH/FDA, CDISC).
• Strong English communication skills.
• Experience with eCRF design and EDC systems is preferred.

Responsabilidades

• Lead a small clinical study or co-lead larger studies with moderate guidance.
• Support multiple studies with minimal guidance.
• Manage and monitor data management activities with CROs or vendors.
• Review protocols for appropriate data capture and eCRF design.
• Review eCRF data requirements in detail.
• Collaborate with CRAs, programmers, study managers and statisticians on eCRFs.

Conocimientos

Data Management

English communication

Educación

Bachelor’s Degree in a scientific/healthcare field

Master's Degree preferred

Herramientas

EDC systems

eCRF design

Descripción del empleo

Parexel FSP is hiring for multiple Clinical Data Manager positions in Colombia, Mexico, Argentina, and/or Brazil.

Job Purpose

The Clinical Data Manager will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide. He/she will participate as an active member of a multi-disciplinary team to plan and execute the Data Management tasks required for phase 1-4 studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance.

Key Accountabilities

• Be able to lead a small clinical study or co-lead a larger study or studies with moderate guidance
• Be able to support several clinical studies with minimal guidance
• Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies
• Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
• Be able to perform a thoroughly detailed review of eCRF data requirements.
• Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
• Develop data edit check specifications and run data listings as required
• Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members
• Develop the Data Management Plan for a clinical study.
• Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications
• Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries
• Perform reconciliation of header data from external data sources against the clinical database
• Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Assist in database upgrades/migrations including performing User Acceptance Testing
• Able to maintain study workbooks and data management files
• Perform database lock and freeze activities per company SOPs
• Participate in regular team meetings and provide input when appropriate
• Provide input into the development of data management SOPs, Work Instructions, and process documents
• Contribute to a professional working environment including the application of the client’s Code of Business Conduct and Ethics
• Assist with the training of new employees and/or contractorsCollaborative relationships
• Collaborates with cross-functional teams to design and implement effective data collection strategies, ensuring high-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle.
• Compliance with Parexel standards
• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements

Knowledge And Experience

• At least two years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment
• Understands the scope and focus of Phase 1-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors.
• Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
• Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable.
• Possesses strong English language written and verbal communication skills.

Education

• Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcare field.