Morrisville, NC30+ days ago
Ability to identify and organize resources and services needed to accomplish tasks, sets objectives, plans for contingencies, and manages time effectively ā¢ Develops and monitors study metrics to continuously assess study progress ā¢ Acts as the primary point of contact between Science 37 and sponsor project team, and independently leads internal and external project team meetings ā¢ Project Analysis and Management: Identifies critical project success factors for tracking, analysis and reporting including impact and probability of project risks ā¢ Monitors and tracks study status, timelines, and budget expenditures; identifies opportunities and recommends implementation plan for efficiency measures ā¢ Ensures timely data entry, query resolution and prompt resolution of data issues ā¢ Coordinates assignment of needed resources for study conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget ā¢ Identifies out-of-scope work and reports the scope change process to leadership ā¢ Assists with the development of a budget/ contract change order as appropriate in conjunction with the Director, Clinical Operations, and the business development teams ā¢ Responsible for review of study budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members ā¢ Ensures that study activities are properly tracked and entered into the company's time tracking/project management/resource planning software tool in a timely manner ā¢ Ability to analyze data and information to derive conclusions and drive critical decision-making ā¢ Assists and supports study audit preparations. Duties include but are not limited to: ā¢ Project Guidelines and Communication: Develops a project management plan in conjunction with the appropriate cross-functional teams, outlining planning, execution, and closeout milestones in addition to communication and contingency plans ā¢ Leads multi-disciplinary Study Management Team ā¢ End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas.