Parexel FSP is hiring for multiple Clinical Data Manager positions in 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 contractors Collaborative 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 5+ 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.

📌 Clinical Data Manager - FSP (México)
🏢 Parexel
📍 México