Senior Clinical Data Manager

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

📋 Description

• Lead or assist in data management study activities, oversight of CRO, and ensure adherence to delivery timelines.

• Act as the representative of the data management function within the Clinical Sub-team, aligning expectations for data-related deliverables with CRO/client.

• Collaborate with client stakeholders to guarantee that milestones and deliverables are achieved with exceptional quality.

• Work alongside stakeholders and CRO partners to identify, mitigate, and resolve potential risks.

• Contribute to functional governance with strategic suppliers and address escalated issues effectively.

• Prepare the function for submission readiness and engage in formal inspections and audits.

• Ensure that Data Management Trial Master File documents are ready for archival and inspections.

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

• Plan and oversee external Data Management budgets and timelines; monitor discrepancies and assist in forecasting improvements.

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

• Maintain standard operating procedures (SOPs), process maps, templates, and timelines.

• Prepare metrics that support functional KPIs as needed.

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

• Contribute to the strategic direction of functional continuous improvement initiatives.

• Ensure adherence to learning curricula, corporate requirements, and GxP standards.

• Collaborate cross-functionally to guarantee data quality in databases, 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 is necessary.

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

• Strong understanding of data management best practices and technologies used in clinical trials.

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

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

• Comprehensive understanding of the broader drug development process and its cross-functional interfaces with data management.

• Strong familiarity with EDC builds.

🏝️ Benefits

• Opportunities for professional growth and substantial career development.

• Chance to work with autonomy and take ownership of projects.

• Receive support from Cytel while integrated with a pharmaceutical client.