Senior Clinical Data Manager

This is a fully remote position, open to applicants in Spain.

📋 Description

• Serve as the Lead Clinical Data Manager for designated data management projects.

• Function as the Project Lead for Biometric-only initiatives.

• Oversee the activities of other Clinical Data Management personnel assigned to the project.

• Examine the Study Protocol.

• Create Case Report Forms (CRFs) or review those generated by the sponsor.

• Design the Database.

• Establish and program edit checks.

• Responsible for preparing, finalizing, and archiving all relevant Data Management documentation.

• Formulate the Data Management Plan and Data Management Report.

• Create the Data Validation Plan (including the definition of edit checks).

• Develop Data Entry Instructions/eCRF completion guidelines.

• Coordinate the validation of the database, edit checks, and trial and site settings.

• Conduct validation of the database, edit checks, and trial and site settings in studies where not the designated Clinical Data Manager.

• Manage CRF handling tasks including logging, tracking, and sorting.

• Assist Clinical Research Associates (CRAs) with study-related inquiries.

• Carry out Data cleaning and query management.

• Ensure the completion of Quality Control tasks for the finalization and transfer of the study database and accompanying documents to the sponsor.

• May coordinate SDTM mapping with the senior programmer when necessary.

• Execute all responsibilities associated with database closure.

• Provide Clinical Data Specialists with study documentation for the sites (patient data, audit trail, and closed queries).

• File/archive critical documents.

• Supply metrics and status updates to senior management, project leaders, and sponsors as required.

• Train and support Clinical Data Associates and Clinical Data Managers.

• Train and assist both internal and external Clinical Study Teams.

• Represent TFS Data Management in meetings with sponsors and investigators.

• Responsible for escalating any project-related issues or potential SOP deviations.

• May conduct system validation, develop test scripts for system validation, and perform User Acceptance Testing (UAT) of electronic Patient-Reported Outcomes (ePROs) in collaboration with the CRA.

• Actively participate in the organization and enhancement of processes to improve operations at TFS.

⛳️ Requirements

• Bachelor's degree in Life Sciences or Computer Science.

• At least 8+ years of Clinical Data Management experience, preferably at a Senior or Lead level within the pharmaceutical or CRO industry.

• Demonstrated experience in study-level data management across various clinical trials and phases (Phase I–III preferred).

• Extensive experience working within CRO/FSP oversight frameworks, with accountability for vendor deliverables.

• Strong familiarity with data review, database locking, and submission-ready data delivery.

• Comprehensive knowledge of the entire data management lifecycle (set-up, conduct, close-out).

• Good understanding of CDISC standards.

• Experience with EDC systems, preferably Veeva EDC.

🏝️ Benefits

• Opportunities for personal and professional development.

• Collaborative team environment.

• Commitment to quality and excellence.