Senior Clinical Data Manager

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

📋 Description

• Oversee or assist with data management study tasks, including CRO supervision and managing deliverable timelines.

• Possess a strong understanding of EDC builds.

• Serve as the data management representative on the Clinical Sub-team, ensuring that expectations between the CRO and client are aligned for all data-related deliverables, particularly for key decision points and regulatory submissions.

• Provide significant leadership in collaboration with other client stakeholders to ensure that established milestones and deliverables are achieved with utmost quality.

• Collaborate with relevant stakeholders and CRO partners to identify and mitigate risks.

• Offer input to functional governance with client strategic suppliers, working with relevant stakeholders to address issues raised by vendors and/or cross-functional teams.

• Engage in preparing the function for submission readiness and may act as a representative during formal inspections or audits.

• Participate in and represent the function in formal inspections and audits as required.

• Ensure the archival and inspection readiness of all Data Management Trial Master File (TMF) documents.

• Guarantee the realization of major data management deliverables and milestones in conjunction with other departments, including the Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics.

• Responsible for planning and managing external Data Management budgets and timelines to ensure accuracy, understand trends in variances, and promote continuous improvement in forecasting.

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

• Maintain SOPs, process maps, templates, and timelines to support the operational and oversight models of the function.

• May prepare metrics to support the function’s KPIs.

• Represent the function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc., to identify industry best practices and enhance the visibility of the client.

• Contribute to functional Continuous Improvement initiatives by providing strategic direction and identifying key deliverables that meet timelines, budgets, and align with company, departmental, or functional requirements.

• Ensure compliance with personal Learning Curricula, corporate standards, and/or GXP requirements.

• Collaborate across functions to ensure data quality in each database and timely delivery, as well as the quality of other data management deliverables.

⛳️ Requirements

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

• At least 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 knowledge of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

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

• Comprehensive knowledge of the drug development process, with expertise in the cross-functional interactions involving the data management function.

🏝️ Benefits

• Our dedication to the development of our staff is only matched by our commitment to enhancing treatment options available to patients.

• We strive to create successful career paths with substantial professional growth for our employees, and consequently, we work diligently to ensure Cytel's success.

• Cytel is a place where talent, experience, and integrity converge to enhance the advancement of clinical development.