Director, Project Management – Clinical Research

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Elligo Health Research

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🧬 Biotechnology

💰 $135M Series E on 2021-09

Healthcare • Pharmaceuticals • Biotechnology

Elligo Health Research is a company that facilitates clinical trials by bridging the gap between research and healthcare. They provide essential tools and services such as patient recruitment, engagement, and innovative technologies, including their proprietary IntElligo® system. With access to a vast network of healthcare and research sites, Elligo supports sponsors, clinical trial sites, and patients in navigating the complex landscape of clinical research across a wide range of therapeutic areas.

📋 Description

• Lead the project management function for all studies delivered through Elligo’s IRO network and DCT/hybrid trial models, ensuring consistent operational execution across sites and vendors. • Develop and maintain the operating rhythm for IRO and DCT project teams, setting a clear vision, roles, and goals for each engagement, removing roadblocks, and owning outcomes. • Partner with Site Network Operations and site-facing teams to ensure integrated sites are equipped, trained, and supported to deliver on study commitments. • Oversee the selection, integration, and performance of decentralized trial vendors and technologies (e.g., telehealth, home health, eConsent, direct-to-patient shipping) in partnership with Clinical Operations and Technology teams. • Develop project plans with clearly established goals, milestones, timelines, and budgets; partner with function heads, external partners, and project teams to keep programs on track, in scope, and within budget. • Serve as senior escalation point for clients and internal stakeholders on IRO and DCT engagements; resolve issues and drive corrective action plans as needed. • Communicate regularly with senior leadership, providing insights, updates, and action items relevant to IRO and DCT portfolio performance. • Inform the company’s strategic roadmap for decentralized and site-network-enabled research by identifying opportunities and participating in feasibility and capability assessments. • Ensure all studies are executed in accordance with Good Clinical Practice (GCP), ICH guidelines, applicable regulatory requirements, and relevant Standard Operating Procedures (SOPs). • Identify critical success factors for IRO and DCT projects and establish frameworks for tracking, analysis, and reporting of program and portfolio performance. • Manage allocation of project management resources across the IRO/DCT portfolio, prioritizing work based on business needs and communicating resourcing needs to departmental leadership. • Develop contingency planning and risk mitigation strategies specific to decentralized trial delivery and integrated site network dependencies. • Lead the development and refinement of SOPs, guidance documents, job aids, tools, and templates specific to IRO and DCT project delivery, acting as a subject matter expert (SME) for the group. • Drive process agility and efficiency across the IRO/DCT portfolio by championing automation, digital tools, and data-driven decision-making. • Oversee study documentation for IRO and DCT projects, ensuring project records remain inspection-ready and current in all applicable systems. • Perform financial oversight for the IRO/DCT project portfolio, including monthly billing, forecasting, scope reviews and amendments, and pass-through cost management. • Contribute to proposal, budget, and contract review for prospective IRO and DCT engagements. • Foster a culture of continuous improvement, accountability, and client-centered delivery across the IRO/DCT project management team.

🎯 Requirements

• Deep knowledge of clinical trial delivery, with direct experience in decentralized, hybrid, and site-network-enabled research models. • Working knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA, and other applicable country regulations. • Demonstrated ability to lead and develop project management teams, including managing matrixed teams and driving change management. • Ability to build and maintain solid relationships with internal stakeholders, integrated sites, technology/DCT vendors, and clients. • Strong organizational skills, with the ability to manage multiple projects and competing priorities within agreed timeframes in a fast-paced environment. • Excellent analytical and problem-solving skills, with strategic thinking and planning capabilities. • Exceptional verbal and written communication skills, including the ability to distill complex issues into clear, actionable terms for varied audiences. • Demonstrated understanding of project financials, contracts, and revenue reporting. • Self-motivated, able to work independently, and effective at collaborating across functions to identify quality solutions. • Proficient with Microsoft Office 365 (Outlook, Word, Excel, PowerPoint, Teams), SharePoint, and CRM systems such as Salesforce; comfortable adopting and leveraging new technology platforms relevant to decentralized trial delivery. • Bachelor’s degree in life science, business, or a related field required; advanced degree preferred. Minimum of eight (8) years of clinical research or project management experience, including at least four (4) years leading high-performing teams. Minimum of eight (8) years of client management and project financial oversight Direct experience supporting decentralized, hybrid, or site-network-based clinical trials strongly preferred. Minimum of five (5) years of experience applying Good Clinical Practice (GCP), relevant SOPs, and regulatory requirements. • Demonstrated experience managing project or program budgets, forecasting, and client financial reporting. • Proven track record coordinating cross-functional and matrixed teams in a time-sensitive, deadline-driven environment.

🏖️ Benefits

• Other non-essential duties that will be regularly performed or are expected to occur normally • Other duties as assigned.