Elligo Health Research

Manager

• Ensuring clinical trial sites operate efficiently, meet timelines, budget, and quality expectations through remote oversight of clinical sites.
• Working closely with Regional Site Directors and other Research Operations leaders.
• Ensures the execution of clinical trial activities in compliance with all applicable regulations.
• Provides close and continued communication with site employees, provides training and mentoring to enhance performance and adherence to best practices.
• Ensure engagement of the team.
• Close collaboration with cross-functional teams, including site-level leadership, to drive successful clinical trial execution, develop site staff, and position sites for study awards.
• Responsibilities include site onboarding, maintaining site research readiness, coaching site staff, reviewing site metrics for decision-making, compiling and leading monthly business reviews, and ensuring quality oversight.
• Key development areas include Adverse Event reporting, Motivational Interviewing, regulatory and compliance updates, and operational changes related to program quality monitoring.
• Craft and execute a strategic approach that enhances site performance, drives business outcomes, and supports the success of Site Operations across their region.

Senior Site Manager

Project Manager

• Support the successful performance and operations of Elligo’s clinical trials
• Serve as a liaison between multiple departments to ensure project tasks are tracked and/or completed
• Coordinate collection and submission of all regulatory related documents
• Obtain and review required medical records, data entry, and other various project support tasks
• Combine organizational skills, technical skills, and communication to complete project-related tasks from study award to study closure

Project Management Specialist – Optimized Trials

• The Manager, Project Management works closely with cross functional areas to develop and execute Project Management strategic plans, projects and commitments to drive operational efficiencies across sites and projects as well as new business opportunities.
• Ensure management of study milestones and proactive communication with clients, application of best practices regarding budget and risk management in order to monitor progress to ensure achievement of Project Management goals.
• Manage and mentor Project Management staff in general team leadership, customer & project management, internal Elligo processes, and project-specific tasks.
• Install and manage a culture of continuous improvement and quality and productivity ensuring the consistent implementation, use and review of SOPs.
• Serve as a client facing point of contact and escalation as needed.
• Responsible for the development and operation of the Project Management function.
• Develop operating rhythm for project teams across the business and for outside service providers, setting the vision for each initiative along with clear expectations, roles and goals for execution, removing roadblocks, and taking ownership of outcomes.
• Develop plans with established goals, milestones, timelines, and budget.
• Partner with function heads, external partners, and the project team to ensure projects and programs stay on track and aligned with corporate goals while also staying within scope and budget and with quality standards.
• Communicate with senior leadership on a regular basis, providing insights, updates and action items relevant to their functions.
• Inform the company’s strategic roadmap by sharing opportunities and participating in assessments.
• Mentor, motivate, and lead team members and contribute to a thriving culture.
• Assess, lead and manage successful projects by driving cross-divisional and cross-functional teams to ensure delivery of the targeted goals and timelines.
• Responsible for leading a team of project managers. Identify critical project success factors for tracking, analysis, and reporting.
• Manage the allocation of resources, prioritize projects based on business needs completion and communicating needs to appropriate departmental managers.
• Ensure projects are executed in accordance with Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs) and regulatory requirements.
• Collaborate with department leaders to ensure administration of appropriate training of those involved with the project.
• Coordinate activities and deliverables of all study team members, acting as a client facing escalation communication and escalation point as needed.
• Develop contingency planning and risk mitigation strategies to ensure successful project delivery. Monitor and track resolution of all client escalations, issues, and concerns.
• Effectively collaborate with others and work across boundaries as necessary assisting in day-to-day operations of the centralized team, working with appropriate BD Directors, and working across functions to remove barriers and optimize client delivery consistently.
• Assist with building new capabilities for the PM organization by becoming a Subject Matter Expert (SME) developing new and/or updating defined SOPs, guidance documents/job aids, tools, and templates to accelerate transformation towards predictive and agile ways of working.
• Drive best-in-class process agility and efficiency, by harnessing innovation to automate data collection and documentation, enhancing compliance, improving quality and robustness of centralized project management process.
• Oversee study documentation and ensuring project records remain inspection ready.
• Perform financial tasks including monthly billing, forecasting, project scope reviews and amendments, along with pass-through cost management.

Senior Site Manager

Project Management Specialist – Optimized Trials

Senior Manager, Project Management