Global Study Start-Up & Site Activation Lead

Alnylam Pharmaceuticals, Inc.; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. is seeking a Senior Manager, Study Start-up to join our dynamic team.

The role partners with the Clinical Operations study team to lead global study start-up and site activation activities in Phase I-III and real-world evidence trials, coordinating with CROs, vendors, and site networks to accelerate delivery. You will oversee end-to-end study startup strategy, planning, timelines, and KPI tracking, ensuring efficient processes, risk mitigation, and on-time

Qualifications

• Bachelor's Degree in Science or related discipline; a higher degree desirable.
• 8+ years experience with a CRO or biopharmaceutical company on multinational studies.
• 5+ years managing operational aspects of clinical studies.
• Experience leading global study start-up and site activation activities.
• Experience with external CROs and cross-functional teams.
• Broad clinical development experience including trial conduct, feasibility, and site selection.
• Knowledge of GCP and regulatory requirements.

Responsibilities

• Drive global study start-up and site activation activities, milestones, and CRO delivery.
• Develop and deliver the global study startup plan with CRO Study Startup team.
• Lead development of procedures to enhance internal startup capabilities and efficiency.
• Guide teams through startup activities to meet timelines and objectives.
• Oversee analysis of trial data for accurate startup forecasts.
• Collaborate with feasibility experts for data-driven forecasts and scenarios.
• Develop processes and technologies to deliver Study Startup Services.
• Participate in early global study planning and CRO commitment to timelines.
• Partner with CRO to ensure efficient startup processes and reporting.
• Resolve site-level issues leveraging in-country intel to remove roadblocks.
• Track KPIs and metrics to support process improvement and reporting.
• Ensure compliant startup standards aligned with regulatory requirements.
• Build and maintain study startup best practices.
• Support junior staff through prioritization and problem solving.

Skills

Project management

Global study start-up

Clinical operations

Vendor collaboration

Cross-functional teamwork

Education

Bachelor's Degree in Science

Job description

Alnylam Pharmaceuticals, Inc. is seeking a Senior Manager, Study Start-up to join our dynamic team.

The role partners with the Clinical Operations study team to lead global study start-up and site activation activities in Phase I-III and real-world evidence trials, coordinating with CROs, vendors, and site networks to accelerate delivery. You will oversee end-to-end study startup strategy, planning, timelines, and KPI tracking, ensuring efficient processes, risk mitigation, and on-time