Senior Clinical Data Manager

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

📋 Description

• Lead or assist in data management study activities, oversee CRO operations, and manage deliverable timelines.

• Develop and supervise EDC systems.

• Act as a representative for data management in Clinical Sub-teams, ensuring alignment of CRO and client expectations for data-related deliverables.

• Collaborate effectively with client stakeholders to achieve milestones and deliverables with a focus on quality.

• Partner with stakeholders and CROs to identify and resolve risks.

• Provide insights for functional governance with strategic suppliers and address escalated issues.

• Prepare the function for submission readiness and represent it during inspections or audits.

• Ensure the archival and inspection readiness of Data Management Trial Master File documents.

• Coordinate data management milestones and deliverables with Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics.

• Plan and manage external Data Management budgets and timelines, analyze variances, and enhance forecasting accuracy.

• Serve as a process expert for operational and oversight models.

• Maintain SOPs, process maps, templates, and timelines.

• Prepare metrics that support functional KPIs.

• Represent the function in external professional initiatives and organizations such as SCDM, CDISC, and DIA.

• Contribute to the strategic direction of continuous improvement initiatives.

• Ensure compliance with learning curricula, corporate policies, and GXP standards.

• Collaborate across functions to ensure data quality, timely delivery, and the quality of other data management deliverables.

⛳️ Requirements

• Bachelor's Degree in a science, health-related, or information technology field is required.

• A minimum of 5 years of experience in Clinical Data Management.

• Experience across all phases of development in one or more therapeutic areas is preferred.

• Strong understanding of data management best practices and technologies as they relate to clinical trials.

• Solid comprehension of clinical trial documents, including protocols, statistical analysis plans, CRFs, and study reports.

• Strong knowledge of FDA and ICH regulations along with industry standards relevant to data capture and management processes.

• Comprehensive understanding of the drug development process.

• Expertise in cross-functional interactions with the data management function.

🏝️ Benefits

• Opportunities for professional growth.

• Work fully integrated within a pharmaceutical client program.

• Enjoy autonomy and ownership in your role.