Senior Manager, Clinical Data Management

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Paradigm Health

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Healthcare Insurance • Pharmaceuticals • Biotechnology

Paradigm Health is changing the model behind clinical research by orienting trials around patient care. Their intelligent research platform connects and empowers patients, providers, and sponsors to create a future where clinical trials are more viable and valuable for all stakeholders in the care ecosystem. By integrating technology and services, Paradigm Health enhances collaboration throughout the clinical trial journey, ensuring that every patient has access to the latest therapies and improving enrollment and outcomes in clinical trials.

51 - 200 employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

💰 Series A on 2023-01

📋 Description

• Lead, mentor, and develop a high-performing team of Clinical Data Managers and CDM operations staff. • Oversee workload allocation, staffing plans, competency development, and performance management. • Foster a culture of excellence, continuous improvement, and accountability within the CDM function. • Provide senior oversight of end-to-end CDM activities across multiple studies, including database development, CRF design, edit check specification, cleaning and reconciliation workflows, and database lock. • Ensure predictable delivery of data management milestones through proactive oversight of timelines, metrics, and quality indicators. • Anticipate operational risks and lead resolution efforts in collaboration with cross-functional partners. • Collaborate closely with Clinical Operations, Biostatistics, Safety, Regulatory, Quality, Product, and Engineering to ensure integrated and efficient data delivery. • Serve as a senior CDM representative in cross-functional study meetings, troubleshooting sessions, and strategic planning discussions. • Align CDM workflows with broader study goals and portfolio-level priorities. • Lead the development, refinement, and adoption of CDM SOPs, templates, libraries, and operational playbooks. • Drive initiatives to streamline workflows, strengthen data quality controls, and enhance scalability across the CDM organization. • Support digital transformation initiatives, including automation, modern EDC capabilities, and advanced data review tools. • Serve as a senior CDM point of contact for sponsors, ensuring transparent communication, timely delivery, and trusted partnership. • Provide proactive updates, risk assessments, and strategic recommendations to internal and sponsor stakeholders. • Contribute to proposal development, data strategy discussions, and operational feasibility assessments for new and ongoing programs.

🎯 Requirements

• 8–12 years of clinical data management experience, with substantial experience leading complex studies or multi-study portfolios. • Proven leadership experience managing data teams and driving high-quality delivery in fast-paced environments. • Deep expertise in EDC systems, CDISC standards, data cleaning and reconciliation processes, and regulatory requirements (ICH-GCP, 21 CFR Part 11, GDPR). • Strong communication skills with the ability to influence, collaborate, and lead across diverse technical and operational teams. • Highly organized, analytical, and committed to data integrity, operational excellence, and continuous improvement. • Able to operate strategically while remaining hands-on with complex problem-solving when needed.

🏖️ Benefits

• Competitive health, dental, and vision insurance • Mental health support for you and your family through Spring Health • Equity package • Unlimited paid time off (PTO) • 16 weeks of paid parental leave • Flexible work options – remote and hybrid arrangements • Company-paid life insurance • Company-paid short-term and long-term disability coverage • One Medical membership • 401(k) plan with company match