Site Operations Manager – Contractor

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Ensure the timely and budget-conscious delivery of clinical studies while adhering to quality benchmarks.

• Lead cross-functional Study Management Teams within a matrix organizational framework.

• Strategize, source, recruit, implement, and finalize clinical studies as per client agreements.

• Supervise the operational facets of clinical trials, ensuring compliance with SOPs, GCP/ICH guidelines, FDA, and state regulations.

• Act as the main liaison for client study teams and sponsor project teams.

• Create comprehensive project management plans encompassing planning, execution, closeout milestones, communication, and contingency plans.

• Develop and oversee study metrics to evaluate study progress.

• Facilitate internal and external project team meetings.

• Monitor study status, timelines, budgets, risks, data entry, queries, and data-related issues.

• Coordinate study resources and staffing within the allocated budget.

• Identify out-of-scope tasks and assist with budget or contract modifications.

• Review study budgets, expense reports, financial documents, invoicing, units, and expenditures.

• Maintain up-to-date records in time-tracking, project management, and resource planning software.

• Assist in preparations for study audits.

• Design, oversee, and deliver training specific to the project team.

• Collaborate on study documentation and manuals, including ICFs, manuals, presentation materials, and risk management plans.

• Establish project protocols, communicate performance expectations, and manage external service providers.

• Provide input for performance evaluations of project team members and service providers.

• Understand client needs and influence decision-making processes.

⛳️ Requirements

• Bachelor's degree or equivalent relevant experience is required.

• A minimum of 2+ years of extensive experience in managing pharmaceutical/biotech-sponsored clinical studies or equivalent relevant experience is required.

• An advanced degree or equivalent clinical research experience is preferred.

• Medical and scientific knowledge is preferred.

• Familiarity with study management and the capability to effectively oversee multiple clinical studies is essential.

• Strong proactive problem-solving skills and ability to follow through on tasks.

• Capacity to adjust to a rapidly changing work environment while managing competing priorities.

• Proven success in managing decentralized teams and making responsive decisions based on the situation.

• Comprehensive understanding of clinical research, the drug development process, the clinical research industry, and the relevant operating environments.

• Experience in reviewing protocols and assessing program and project risks.

• Proven ability to build and guide organizational teams.

• Excellent written, verbal communication, and presentation skills.

• Proficient in MS Office suite and Google applications.

• Willingness to gain expertise in proprietary software.

• Ability to manage and track multiple study budgets with a clear understanding of study finances.

• Proficient in English communication, both verbal and written.

• Availability to travel up to 20% as required.

🏝️ Benefits

• Science 37 prioritizes the well-being of its employees and strives to equip team members with the necessary resources for success.

• Opportunity to travel up to 20% for project team meetings, client presentations, and other professional engagements/conferences.