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Director, Data Management
Location
Massachusetts
Posted
2 days ago
Salary
$160K - $210K / year
Seniority
Lead
Job Description
Director, Data Management
eClinical Solutions
• Provide day-to-day leadership, operational oversight, and strategic direction for Clinical Data Management teams delivering end-to-end data management services across global programs and studies. • Ensure high-quality, timely, and cost-effective delivery of clinical data management services that meet customer expectations, contractual commitments, and organizational objectives. • Drive operational excellence through effective planning, resource management, risk management, financial oversight, and performance monitoring. • Establish, monitor, and report on key operational metrics related to quality, productivity, utilization, customer satisfaction, delivery predictability, revenue, and margin performance. • Proactively identify, escalate, and resolve operational, quality, and delivery risks that may impact customer outcomes or business performance. • Build, develop, mentor, and retain high-performing Clinical Data Management professionals through effective coaching, performance management, and career development. • Foster a culture of accountability, collaboration, innovation, continuous improvement, and customer focus across the Clinical Data Management organization. • Lead workforce planning, resource forecasting, succession planning, and organizational capability development to support current and future business needs. • Ensure Clinical Data Management activities are conducted in compliance with SOPs, ICH/GCP guidelines, regulatory requirements, and applicable quality standards while maintaining inspection readiness. • Partner with customers, internal stakeholders, and cross-functional teams to ensure successful execution of programs and delivery of exceptional customer outcomes. • Develop and maintain strong customer relationships through consultative partnership, delivery excellence, transparency, and responsiveness. • Serve as a senior escalation point for customer concerns and ensure timely resolution of issues impacting delivery, quality, or customer satisfaction. • Lead the modernization of Clinical Data Management operations through the adoption and operationalization of AI/ML-enabled data review, advanced analytics, automation, and Risk-Based Quality/Data Management (RBQM/RBDM) methodologies. • Lead initiatives that modernize clinical data review processes and transition teams from traditional review approaches to scalable, intelligent, and human-in-the-loop workflows. • Partner with Clinical Data Management leadership, Product, Technology, and other stakeholders to execute strategies that evolve data management capabilities and operating models. • Champion adoption of the elluminate platform and related technologies, ensuring capabilities are effectively embedded into operational workflows and deliver measurable value to customers and the organization. • Identify opportunities to improve efficiency, scalability, data quality, and speed of insight through innovative technologies, process improvements, and data-driven approaches. • Serve as a Clinical Data Management subject matter expert, contributing to strategic initiatives, customer engagements, innovation efforts, and the advancement of modern data management practices. • Support business development activities through proposal support, customer presentations, strategic consulting, and participation in sponsor engagements. • Provide regular updates to Clinical Data Management leadership regarding operational performance, organizational health, risks, opportunities, and key transformation initiatives.
Job Requirements
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, Pharmacy, Biotechnology, or related discipline, or equivalent work experience.
- Minimum of 12 years of progressive Clinical Data Management experience, including experience leading global delivery teams and customer-facing data management programs.
- Demonstrated experience leading Clinical Data Management organizations or teams and delivering multiple concurrent customer programs and studies.
- Experience managing customer relationships and leading customer-facing delivery organizations.
- Experience supporting implementation of data management modernization initiatives, analytics-driven processes, automation, or AI-enabled capabilities preferred.
- Strong leadership and organizational management capabilities with demonstrated experience building, developing, and leading high-performing Clinical Data Management teams.
- Proven ability to drive operational excellence, delivery quality, customer satisfaction, and financial performance across multiple programs, studies, and customers.
- Demonstrated experience managing complex customer relationships and serving as a trusted advisor to sponsors and key stakeholders.
- Strong people leadership skills, including coaching, mentoring, performance management, talent development, and succession planning.
- Experience leading organizational change and driving adoption of modern Clinical Data Management practices, technologies, and operating models.
- Demonstrated ability to lead cross-functional initiatives and influence stakeholders across Operations, Product, Technology, and Customer organizations.
- Demonstrated ability to operationalize innovative solutions, including AI/ML-enabled data review, analytics-driven oversight, automation, and Risk-Based Quality/Data Management (RBQM/RBDM) methodologies.
- Strong project and operational management skills, including resource planning, financial management, risk management, and organizational prioritization.
- Ability to translate complex business, operational, and technical concepts into practical, scalable solutions that deliver measurable value.
- Excellent verbal, written, presentation, and interpersonal communication skills, with the ability to effectively influence stakeholders at all levels of the organization.
- Strong organizational and problem-solving skills with the ability to manage multiple priorities in a fast-paced, customer-focused environment.
- Strong knowledge of Clinical Data Management processes, clinical trial methodology, ICH/GCP guidelines, and 21 CFR Part 11 requirements.
- Strong experience with Electronic Data Capture (EDC) and Clinical Data Management systems; Medidata Rave experience preferred.
- Experience with modern clinical data platforms, SaaS-based solutions, and data acquisition technologies; elluminate experience is a strong plus.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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