Director, Data Management

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

📋 Description

• Provide daily leadership, operational oversight, and strategic guidance for Clinical Data Management teams that deliver comprehensive data management services across global programs and studies.

• Ensure the delivery of high-quality, timely, and cost-effective clinical data management services that align with customer expectations, contractual obligations, and organizational goals.

• Drive operational excellence through efficient planning, resource allocation, risk management, financial oversight, and performance tracking.

• Establish, monitor, and report on key operational metrics related to quality, productivity, utilization, customer satisfaction, delivery predictability, revenue, and margin outcomes.

• Proactively identify, escalate, and resolve operational, quality, and delivery risks that may affect customer results or business performance.

• Build, develop, mentor, and retain high-performing Clinical Data Management professionals through effective coaching, performance management, and career progression.

• Cultivate a culture of accountability, collaboration, innovation, continuous improvement, and customer orientation throughout the Clinical Data Management organization.

• Lead workforce planning, resource forecasting, succession planning, and the development of organizational capabilities to meet current and future business demands.

• Ensure that Clinical Data Management activities comply with SOPs, ICH/GCP guidelines, regulatory standards, and applicable quality benchmarks while maintaining readiness for inspections.

• Collaborate with customers, internal stakeholders, and cross-functional teams to ensure successful program execution and the delivery of outstanding customer results.

• Develop and sustain strong customer relationships through consultative partnerships, delivery excellence, transparency, and responsiveness.

• Act as a senior escalation point for customer issues and ensure the prompt resolution of matters affecting delivery, quality, or customer satisfaction.

• Lead the modernization of Clinical Data Management operations through the adoption and application of AI/ML-enabled data review, advanced analytics, automation, and Risk-Based Quality/Data Management (RBQM/RBDM) methodologies.

• Drive initiatives that modernize clinical data review processes and transition teams from traditional review methods to scalable, intelligent, human-in-the-loop workflows.

• Collaborate with Clinical Data Management leadership, Product, Technology, and other stakeholders to implement strategies that enhance data management capabilities and operational models.

• Advocate for the adoption of the elluminate platform and related technologies, ensuring capabilities are effectively integrated into operational workflows and provide measurable value to customers and the organization.

• Identify opportunities to enhance efficiency, scalability, data quality, and speed of insight through innovative technologies, process improvements, and data-driven strategies.

• Serve as a subject matter expert in Clinical Data Management, contributing to strategic initiatives, customer collaborations, innovation efforts, and the advancement of modern data management practices.

• Support business development activities by providing proposal assistance, customer presentations, strategic consulting, and engaging with sponsors.

• Provide regular updates to Clinical Data Management leadership regarding operational performance, organizational health, risks, opportunities, and key transformation initiatives.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Health Sciences, Nursing, Pharmacy, Biotechnology, or a related field, or equivalent work experience.

• At least 12 years of progressive experience in Clinical Data Management, including leadership of global delivery teams and management of customer-facing data management programs.

• Proven experience leading Clinical Data Management organizations or teams and managing multiple concurrent customer programs and studies.

• Experience in managing customer relationships and directing customer-facing delivery organizations.

• Preferred experience in supporting the implementation of data management modernization initiatives, analytics-driven processes, automation, or AI-enabled capabilities.

• Strong leadership and organizational management skills with a track record of building, developing, and leading high-performing Clinical Data Management teams.

• Demonstrated ability to drive operational excellence, delivery quality, customer satisfaction, and financial performance across various programs, studies, and clients.

• Proven experience in 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 in leading organizational change and promoting the adoption of modern Clinical Data Management practices, technologies, and operating models.

• Demonstrated capacity to lead cross-functional initiatives and influence stakeholders across Operations, Product, Technology, and Customer organizations.

• Proven 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, encompassing 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, enabling effective influence of stakeholders at all organizational levels.

• Strong organizational and problem-solving abilities with the capacity to manage multiple priorities in a fast-paced, customer-oriented environment.

• Comprehensive knowledge of Clinical Data Management processes, clinical trial methodology, ICH/GCP guidelines, and 21 CFR Part 11 requirements.

• Extensive experience with Electronic Data Capture (EDC) and Clinical Data Management systems; experience with Medidata Rave is preferred.

• Familiarity with modern clinical data platforms, SaaS-based solutions, and data acquisition technologies; experience with elluminate is a significant plus.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options