Global Study Lead
Alnylam Pharmaceuticals
August 21, 2026
Remote friendly (Philadelphia, PA)
United States
Clinical Research and Development
The Global Study Lead (Sr. Manager, Clinical Operations) leads operational planning and execution of global clinical trials from study start-up through closeout, providing cross-functional leadership to ensure objectives are achieved on time, within budget, and in compliance with applicable regulations, Good Clinical Practice (GCP), and company procedures.
Responsibilities:
- Lead cross-functional trial teams to develop and execute study operational plans; ensure end-to-end delivery.
- Accountable for trial-level delivery: timelines, budget management, quality oversight, key milestones, and critical deliverables.
- Oversee CRO/vendor selection, onboarding, contracting, performance monitoring, budgeting, and issue resolution.
- Proactively identify and mitigate operational risks; ensure deliverables/milestones meet corporate and study goals.
- Ensure trial operations are compliant with global health authority regulations and internal operating procedures.
- Support Health Authority Inspections and internal QA audits; maintain inspection-readiness with R&D Quality.
- Drive continuous improvement in execution, efficiency, quality, and cross-functional collaboration.
- Mentor and support onboarding/development of Study Management colleagues.
- Partner with internal stakeholders (e.g., Finance, Program Management, Quality, Regulatory, Clinical Research, Data/Statistics, Safety, Supply, etc.).
- Provide budget variance analysis and notify Finance of projected cost over/under.
- Provide operational updates, risks, and recommendations to governance/leadership forums.
- Travel ~10% (flexible as needed).
Qualifications:
- BS/BA required.
- 7+ years clinical research experience (CRO/biotech/pharma) on Phase 1-4 global trials.
- 3-5 years leading end-to-end global clinical trials; experience with Phase 3 registrational trials.
- Experience managing global trials outsourced to a CRO.
- Strong decision-making, analytical, financial, leadership, organizational, planning, communication, and problem-solving skills.
- Demonstrated success leading cross-functional teams in global matrix organizations; results through influence.
- Experience mentoring/coaching others.
- Proficient with MS Office (Excel, Word, PowerPoint) and MS Project.
Responsibilities:
- Lead cross-functional trial teams to develop and execute study operational plans; ensure end-to-end delivery.
- Accountable for trial-level delivery: timelines, budget management, quality oversight, key milestones, and critical deliverables.
- Oversee CRO/vendor selection, onboarding, contracting, performance monitoring, budgeting, and issue resolution.
- Proactively identify and mitigate operational risks; ensure deliverables/milestones meet corporate and study goals.
- Ensure trial operations are compliant with global health authority regulations and internal operating procedures.
- Support Health Authority Inspections and internal QA audits; maintain inspection-readiness with R&D Quality.
- Drive continuous improvement in execution, efficiency, quality, and cross-functional collaboration.
- Mentor and support onboarding/development of Study Management colleagues.
- Partner with internal stakeholders (e.g., Finance, Program Management, Quality, Regulatory, Clinical Research, Data/Statistics, Safety, Supply, etc.).
- Provide budget variance analysis and notify Finance of projected cost over/under.
- Provide operational updates, risks, and recommendations to governance/leadership forums.
- Travel ~10% (flexible as needed).
Qualifications:
- BS/BA required.
- 7+ years clinical research experience (CRO/biotech/pharma) on Phase 1-4 global trials.
- 3-5 years leading end-to-end global clinical trials; experience with Phase 3 registrational trials.
- Experience managing global trials outsourced to a CRO.
- Strong decision-making, analytical, financial, leadership, organizational, planning, communication, and problem-solving skills.
- Demonstrated success leading cross-functional teams in global matrix organizations; results through influence.
- Experience mentoring/coaching others.
- Proficient with MS Office (Excel, Word, PowerPoint) and MS Project.