Site Operations Manager I

Duties and Responsibilities

Project Guidelines and Communication:

• Develops a project management plan with cross-functional teams, outlining planning, execution, and closeout milestones, along with communication and contingency plans.
• Leads a multi-disciplinary Study Management Team.
• Manages clinical studies end-to-end to ensure appropriate resourcing and timely, high-quality delivery by all functional areas, including identifying and organizing necessary resources and services.
• Develops and monitors study metrics to continuously assess study progress.
• Acts as the primary point of contact between Science 37 and the sponsor project team, leading both 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, identifying opportunities and recommending 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, ensuring appropriate staffing within budget.
• Identifies out-of-scope work and reports scope changes to leadership.
• Assists with the development of budget/contract change orders in conjunction with the Director, Clinical Operations, and business development teams.
• Reviews study budgets, expense reports, and financial records (invoicing/units/expenses) with the appropriate project team members.
• Ensures study activities are properly tracked and entered into the company’s time tracking/project management/resource planning software tool.
• Analyzes 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.
• Applies expertise in day-to-day Clinical Operations activities, collaborating with internal and external cross-functional team members to develop study documents and manuals, including ICFs, manuals, presentation decks, and risk plans.
• Determines needed project processes and trains study teams, maintaining team knowledge and application of project processes.
• Establishes and communicates team performance expectations and guidelines.
• Manages performance of external service providers as required.
• Provides performance evaluation input for Science 37 project team members and service providers.

Business Development:

• Understands customer needs and appropriately influences decision-making.