Global Study Start-up Lead: Strategy & Activation

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

Benefits offered by this job

Medical benefits

Dental & vision

401(k) with match

Paid time off

Wellness days

Recharge breaks

Family resources

Job summary

Alnylam Pharmaceuticals is seeking a Senior Manager, Study Start-up to join our dynamic Clinical Operations team. This role partners with the study team to lead global start-up and site activation activities across Phase I-III trials, coordinating with CROs, vendors, and KOLs to accelerate delivery and enrollment milestones.

You will oversee end-to-end study startup strategy, plans, and timelines, drive data-driven forecasting, mitigate risks, and share best practices across study teams to

Qualifications

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

Responsibilities

• Drive global study start-up and site activation activities, milestone oversight, and CRO delivery.
• Develop and deliver the global study startup plan with the CRO Study Startup team.
• Lead development of procedures to enhance internal startup capabilities and drive efficiencies.
• Guide study teams through startup activities within timelines for predictable delivery.
• Oversee analysis of clinical trial data and its application to startup forecasts.
• Collaborate with Feasibility experts to drive data-driven startup forecasts and planning.
• Develop processes and technologies to ensure ongoing delivery of Study Startup Services.
• Participate in early global strategic study planning to align with corporate goals and CRO commitments.
• Partner with CRO to ensure efficient startup processes and reporting.
• Progress site activations with in-country intel to remove roadblocks.
• Track KPIs and metrics to support process improvement and reporting.
• Maintain startup standards to deliver high quality, compliant studies.
• Build and maintain study startup best practices; support junior staff.

Skills

Global startup leadership

Cross-functional collaboration

Project management

Regulatory knowledge

GCP knowledge

Education

Bachelor’s Degree in Science or related discipline

Advanced degree desirable

Job description

Alnylam Pharmaceuticals is seeking a Senior Manager, Study Start-up to join our dynamic Clinical Operations team. This role partners with the study team to lead global start-up and site activation activities across Phase I-III trials, coordinating with CROs, vendors, and KOLs to accelerate delivery and enrollment milestones.

You will oversee end-to-end study startup strategy, plans, and timelines, drive data-driven forecasting, mitigate risks, and share best practices across study teams to