Global Study Operations Leader

Alnylam Pharmaceuticals; United States; On-site; USD 145,000 - 196,000; Full time

Job summary

Alnylam Pharmaceuticals seeks a Sr. Manager, Clinical Operations to lead the planning and execution of global clinical trials from start-up through closeout.

You will guide cross-functional teams to meet timelines, budgets, and regulatory requirements, while mitigating risks and upholding quality across programs. You will mentor Study Management colleagues, coordinate with Finance, Quality, Data Management, and Regulatory, and drive continuous improvement in trial delivery and collaboration.

Qualifications

• BS/ BA degree is required.
• Minimum 7+ years of clinical research experience with CRO, Biotech or Pharmaceutical Company on Phase 1-4 trials.
• 3-5 years leading end to end global clinical trials including Phase 3 registrational trials.
• Experience leading global trials outsourced to a CRO and managing all aspects of trial execution.
• Excellent decision-making, analytical and financial management skills.
• Strong leadership, collaboration, and ability to operate with limited supervision.
• Proven track record of cross-functional influence in global matrix organizations.
• Experience mentoring/ coaching others.
• Excellent organizational, prioritization and problem solving abilities.
• Proficient with MS Office Suite (Excel, Word, PowerPoint) and MS Project.

Responsibilities

• Lead cross-functional trial teams to develop and execute study operational plans and deliver end-to-end trial execution.
• Accountable for trial-level delivery including timelines, budget, quality oversight, milestones and deliverables.
• Oversee CRO and vendor selection, onboarding, contracting, budget management and monitoring.
• Identify operational risks and ensure mitigations and contingencies are initiated.
• Ensure trials comply with global regulations, GCP and internal procedures.
• Participate in Health Authority inspections and internal QA audits.
• Maintain inspection-readiness with R&D Quality oversight.
• Drive continuous improvement in study execution, efficiency, quality and collaboration.
• Mentor Study Management colleagues and share best practices.

Skills

Cross-functional leadership

Budget management

Risk management

Project planning

Communication

MS Office & MS Project

Education

BS/BA degree

Tools

MS Office

MS Project

Job description

Alnylam Pharmaceuticals seeks a Sr. Manager, Clinical Operations to lead the planning and execution of global clinical trials from start-up through closeout.

You will guide cross-functional teams to meet timelines, budgets, and regulatory requirements, while mitigating risks and upholding quality across programs. You will mentor Study Management colleagues, coordinate with Finance, Quality, Data Management, and Regulatory, and drive continuous improvement in trial delivery and collaboration.