Senior Clinical Data Manager

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Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Lead or support data management study activities, CRO oversight, and delivery timelines • Represent the data management function on the Clinical Sub-team and align CRO/client expectations for data-related deliverables • Collaborate with client stakeholders to ensure milestones and deliverables are met with high quality • Partner with stakeholders and CRO partners to mitigate and resolve risks • Provide input to functional governance with strategic suppliers and resolve escalated issues • Prepare the function for submission readiness and participate in formal inspections and audits • Ensure archival and inspection readiness of Data Management Trial Master File documents • Coordinate major data management deliverables and milestones with Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics • Plan and manage external Data Management budgets and timelines; monitor variances and support forecasting improvement • Act as a process expert for operational and oversight models • Maintain SOPs, process maps, templates, and timelines • Prepare metrics supporting functional KPIs as needed • Represent the function in external professional initiatives and organizations such as SCDM, CDISC, and DIA • Contribute strategic direction to functional continuous-improvement initiatives • Ensure compliance with learning curricula, corporate requirements, and GxP requirements • Work cross-functionally to ensure database data quality, timely delivery, and quality of other data management deliverables

🎯 Requirements

• Bachelor's Degree in a science, health-related, or information technology field required • Minimum 5 years of experience in Clinical Data Management • Experience with all phases of development in one or more therapeutic areas preferred • Strong knowledge of data management best practices and technologies applied to clinical trials • Solid understanding of clinical trial documents, including protocols, statistical analysis plans, CRFs, and study reports • Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management processes • Strong knowledge of the broad drug development process and cross-functional interfaces with data management • Strong knowledge of EDC builds

🏖️ Benefits

• Professional growth and significant career development opportunities • Opportunity to work with autonomy and ownership • Support from Cytel while embedded with a pharmaceutical client