Director, Data Management

🔥 19 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $160k - $210k / year

⏰ Full Time

🔴 Lead

👔 Director

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eClinical Solutions

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2012

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Private Equity Round on 2020-01

Biotechnology • Pharmaceuticals • Healthcare Insurance

eClinical Solutions is a clinical data management company that provides integrated data review and management solutions for the biotech and pharmaceutical industries. Their platform, elluminate, empowers organizations to modernize and automate their clinical data workflows, ensuring efficient data acquisition, management, and analysis. By leveraging advanced analytics and technology-driven approaches, eClinical Solutions helps streamline trial operations and improve productivity, enabling better decision-making in clinical research.

📋 Description

• 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.

🎯 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