Site Operations Manager

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 include but are not to be limited to:

• 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

• 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

• Accountable for development, oversight and delivery of team training for specific projects
• Applies expertise in day-to-day Clinical Operations activities, collaborates with internal and external cross-functional team members to develop study documents and manuals, including ICFs, manuals, presentation decks, risk plans, etc.
• Determines needed project processes and trains study teams; maintains study 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

• Understands customer needs and appropriately influences decision-making.

• Bachelor’s degree or equivalent applicable experience required. Advanced degree or equivalent clinical research experience preferred.
• Minimum of 2+ years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience required
• Medical and scientific knowledge preferred
• Knowledge in study management - Demonstrates ability to successfully manage multiple clinical studies. Proactive problem-solving abilities and follow-through.
• Knowledge of field organizational strategies - Ability to adapt to a rapidly…