Clinical Site Project Manager

Lightship is a clinical trials service provider leading in increasing access and choice in taking part in research to improve equity for all. The Clinical Site Project Manager is responsible for leading cross-functional teams to ensure successful project delivery and managing client relationships related to operational delivery of assigned projects.

Responsibilities:

• Leading cross-functional teams and third parties/vendors to ensure successful project delivery
• Overseeing clinical research conduct, including study start-up, enrollment, execution, and close-out
• Acting as liaison with the client and managing client contractual, organizational and relationship needs/expectations, related to operational delivery of assigned projects
• Managing project contractual deliverables and modifications, and preparing and delivering study-related updates, dashboards and reports to study teams, senior management, and sponsors / vendors / partners, including but not limited to: Recruitment, screening, and enrollment reports Key Performance Indicators / Metrics Status of Deliverables Summary of risks / issues and their mitigation / resolutions Summary reports of data flow, protocol deviations, safety reports, and other reports as applicable
• Ensuring project management systems are updated weekly to reflect accurate project status
• Serving as a point of escalation for project team members
• Ensuring project resources are appropriately assigned in project management system and updating forecasted project hours per resource to accurately reflect project needs
• Reviewing and approving reported project hours and ensuring project team report hours appropriately and in a timely fashion
• Participating in revenue forecasting and review of project actual unit/hours efficiency against budget
• Identifying and managing scope changes with the client with support of the project Director (as necessary)
• Ensuring Director and Client Partner are kept informed of project progress through the provision of appropriate and regular updates
• Developing operational plans (including operational guidelines, manuals and project plans as needed)
• Overseeing all operational aspects of assigned clinical studies in accordance with local regulations, ICH GCP guidelines, SOPs (Standard Operating Procedures), and project specific plans, including but not limited to: Managing, reviewing, and maintaining study-related essential documents (e.g., financial disclosure forms, study manuals, etc.) Coordinating IRB/IEC correspondence and communication, ensuring that all approvals are obtained as required Overseeing that study supplies and equipment are procured and delivered to patients and/or sites Organizing / ensuring that appropriate study training is delivered, and maintaining the project specific training matrix and ensuring project team compliance with project specific training Ensuring that the necessary technological solutions are designed and configured per study specifications Ensuring that the vendors / personnel needed for each study are prepared, available, and trained, and managing assigned vendors as necessary Working with study monitors to address issues and provide resolutions
• Acting as the main point of contact for study investigator, study personnel, and sponsors / vendors / partners to ensure smooth communication and collaboration
• Supporting Study Start-Up with the coordination of site contracts
• Working with Legal to implement vendor contracts
• Working with Quality to identify and mitigate risks
• Working with Finance to ensure accurate and timely invoicing to sponsors and tracking and payment of invoices from investigators and vendors
• Preparing requisite project status updates in keeping with project plans at a set cadence, and tailoring messaging as necessary for different internal and external audiences
• Organizing and leading study team meetings, and meetings with sponsors / vendors / partners as applicable
• Participating in the development, review, and implementation of standard operating procedures, manuals, tools, and training materials
• Identifying and documenting lessons learned and best practice throughout each project, and sharing at a functional and departmental level
• Supporting audits and inspections, as required
• Ensuring adherence to company SOPs, policies, and guidelines at the project-level
• Acting as a subject matter expert or Business Process Owner (BPO) for clinical systems, where assigned

Requirements:

• Highly developed spoken and written communication skills, excellent presentation skills
• Knowledge/expertise in the applicable regulations/guidelines for, and the conduct of clinical trials (virtual/DCT trial experience preferred)
• Experience using a Clinical Trial Management System (CTMS) platform or equivalent
• Strong interpersonal, collaboration and time management skills
• Ability to establish and maintain effective working relationships with project team members, other cross functional stakeholders, and clients
• Proactive, innovative problem solver with good analytical and critical thinking skills to appropriately anticipate and manage risks before they turn into issues, as well as to identify the root cause of issues and implement solutions, escalating to management for support appropriately
• Ability to influence stakeholders at all levels with confidence and adapt style to deliver messaging. Issues may be complex, audience perspectives may be divergent, and information may be non-routine in nature
• Able to work in a fast-paced, evolving environment
• Ability to embrace and manage change, be agile and adaptable
• Able to work independently with minimal guidance in an unstructured environment
• Undergraduate, health-related degree OR an equivalent combination of education, training, and experience sufficient to successfully perform the key responsibilities of the job
• 5+ years of relevant clinical research experience and solid knowledge and understanding of clinical project / trial management
• Experience working in a CRO, Site, SMO or Sponsor preferred