Site Operations Manager- Contractor

POSITION OVERVIEW The Site Operations Manager I is a member of the Clinical Operations department accountable for on-time and on-budget delivery of clinical studies using the highest quality standards. The Site Operations Manager I will have a broad therapeutic knowledge leading the multifunctional study management team within a matrix environment. The study management team is collectively responsible for planning, solutioning, recruiting, executing, and close-out of clinical studies, within the scope of the client agreement. In doing so, the Site Operations Manager I will oversee all operational aspects of clinical trials according to and in compliance with corporate and project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines and other applicable federal (FDA) and state regulations, to achieve established goals within timelines and budget. The Site Operations Manager I is the single point of contact to client study teams working with internal and external stakeholders. This individual is accountable for the delivery of the project objectives on-time and on-budget and is responsible for end-to-end execution of clinical trials to ensure effective and timely internal and external communication of study progress, issues, and plans for resolution. The Site Operations Manager I is also responsible for efficient resourcing and financial management of studies under their supervision. DUTIES AND RESPONSIBILITIES Duties include but are not limited to: 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 • Leads multi-disciplinary Study Management Team • End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas. Ability to identify and organize resources and services needed to accomplish tasks, sets objectives, plans for contingencies, and manages time effectively. • Develops and monitors study metrics to continuously assess study progress • Acts as the primary point of contact between Science 37 and sponsor project team, and independently leads internal and external project team meetings Project Analysis and Management • Identifies critical project success factors for tracking, analysis and reporting including impact and probability of project risks • Monitors and tracks study status, timelines, and budget expenditures; identifies opportunities and recommends implementation plan for efficiency measures • Ensures timely data entry, query resolution and prompt resolution of data issues • Coordinates assignment of needed resources for study conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget • Identifies out-of-scope work and reports the scope change process to leadership • Assists with the development of a budget/ contract change order as appropriate in conjunction with the Director, Clinical Operations, and the business development teams. • Responsible for review of study budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members • 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 • Ability to analyze data and information to derive conclusions and drive critical decision-making • Assists and supports study audit preparations Leadership • Accountable for development, oversight and delivery of team training for specific projects •