Project Manager - Clinical Research PMOThe Project Manager - Clinical research is responsible for the overall coordination and management of clinical trials through all phases of trial execution (pre-trial planning, trial execution, monitoring & evaluation, closeout). Initiating: Define vision and initial project scope, identify stakeholders. Planning: Establish and define total scope of the project, build timelines, establish risks, milestones, stakeholder management, and budgets. Planning is a significant portion of the project. Execution: Acquire, develop, and manage the teams, perform quality assurance, manage communications, engage stakeholders, and attain goals. Monitoring and controlling: Make adjustments along the way and determine if project needs to be adjusted, continue, or terminated. Control project work, scope, schedule, cost, communications, and risk. Closing: End the project using a formalized process.Responsibilities:
- Lead global clinical trials from start up to close out in various therapeutic areas
- Cross Team Project Management working across Clinical Trials, Research, Finance, Administration, Ops.
- Track and Optimize projects using; MS Project, Smart Sheets, and Appian BPMN
- Capture and document project charter, project plans, schedules, resource requirements, milestones, dependencies, critical path, and mitigation options.
- Project Management of multiple Clinical Research Projects working with team and management to develop plans/guidelines for project implementation using MS Project, Sheets, Appian BPMN tools. Monitors and analyzes project status to ensure successful completion of project parameters, milestones, timetables (i.e., regulatory document, research agreement, interim monitoring, CRF retrieval, CRF data entry, etc.). Ensures teams are updating internal tracking. Works with team to identify potential risks, develop contingency plans.
- Acts as principal liaison between Sponsor, Clinical trials, research, finance, administration, operations, and IT by facilitating the flow of information between study teams and leadership. Provides Sponsor with timely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work.
- Plans and communicates to team members study specific tasks and priorities for projects. Liaises with managers in all functional areas to optimize performance and utilization of the project team members. Appropriately escalates any issues or potential issues to leadership for all project related issues.
- Works with the project team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets. Works closely with Project Management Director or Associate Director to provide status reporting and milestone delivery.
- Process Improvement - Model existing processes, quantify metrics, gain baseline approval, identify pain points, bottlenecks, and opportunities for improvement. Work with team members to optimize processes.
- Bachelors (BA/BS) Degree or 4 years of additional experience required.
- 5+ yr Project Management using standard project lifecycle methodologies (PMBOK, Lean or Agile).
- Minimum 2 years of Clinical Project Management experience in the clinical research industry
- Experience managing clinical research projects full Clinical lifecycle (Pre-Trial, Execution, Monitoring, Close)
- Cross Team Project Management across Clinical Trials, Research, Finance, Administration, Operations.
- Certifications: PMP Certification, Lean (LSSBB), Agile. ACRP Project Manager (ACRP-PM) nice to have.
- Experience with MS Project, O365, MS Teams, Outlook, PowerPoint. Smartsheets and SharePoint helpful. Familiarity with Appian BPMN or similar Process Improvement tooling.
- Strong Communication, Organizational, Management and Analytical skills