Senior Clinical Data Manager

Job not on LinkedIn

🔥 7 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 25%

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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

• Independently lead data management study activities, CRO oversight, and deliverable timelines • Build EDC systems utilizing RAVE • Represent data management on the Clinical Sub-team and align CRO and client expectations for data deliverables • Collaborate with stakeholders to meet milestones and deliverables with high quality • Partner with stakeholders and CRO partners to mitigate and resolve risks • Support functional governance with strategic suppliers and resolve escalated issues • Prepare the function for submission readiness and represent it in inspections or audits • Maintain archival and inspection readiness of Data Management Trial Master File documents • Coordinate data management deliverables and milestones with Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics • Plan and manage external Data Management budgets and timelines, including variance analysis and forecasting • Act as a process expert for operational and oversight models • Maintain SOPs, process maps, templates, and timelines • Prepare metrics supporting functional KPIs • Represent the function in external professional initiatives and organizations such as SCDM, CDISC, and DIA • Contribute strategic direction to continuous improvement initiatives • Ensure compliance with learning curricula, corporate, and GXP requirements • Work cross-functionally to ensure database data quality, on-time delivery, and quality of data management deliverables • Perform other duties as assigned

🎯 Requirements

• Proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience • Bachelor's Degree in a science, health related, or IT field • Minimum 6 years' experience in Clinical Data Management at the CRO or pharma level • 2 years as a CDM lead • Experience with all phases of development • Strong knowledge of data management best practices and technologies • Experience with Elluminate is preferred, not required

🏖️ Benefits

• Commitment to developing staff and supporting significant professional growth