Global Study Lead
Alnylam Pharmaceuticals
August 21, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Global Study Lead (Sr. Manager, Clinical Operations)
Summary of Key Responsibilities
- Lead cross-functional trial teams to develop and execute study operational plans and ensure end-to-end trial execution.
- Accountable for trial-level delivery: timelines, budget management, quality oversight, key milestones, and critical deliverables.
- Oversee CRO/vendor selection, onboarding, contracting, budget management, performance monitoring, and issue resolution.
- Proactively identify and mitigate operational risks; ensure deliverables and milestones meet corporate and study goals.
- Ensure trial is operationalized in compliance with global health authority regulations/guidelines and internal operating procedures.
- Participate in Health Authority Inspections and internal QA audits; maintain inspection-readiness with R&D Quality.
- Drive continuous improvement in study execution, operational efficiency, quality, and cross-functional collaboration.
- Mentor and support onboarding/development of Study Management colleagues.
- Interface with key internal stakeholders (e.g., Finance, Program Management, Safety, Quality Assurance, Data Management, Statistics, Clinical Research, Regulatory, etc.), acting as a liaison when needed.
- Provide budget variance analysis (budget vs. actual) and notify finance of projected over/under spend.
- Prepare operational updates, risks, and recommendations for governance and leadership forums.
- Travel ~10% (flexible per business need).
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, including Phase 3 registrational experience.
- Experience managing global trials outsourced to a CRO.
- Strong decision-making, analytical, financial, leadership, organizational, and problem-solving skills.
- Demonstrated success leading cross-functional teams in global matrix organizations; results through influence.
- Experience mentoring/coaching.
- Strong project planning/management and communication (written/verbal) and presentation skills.
- Proficient with MS Office (Excel, Word, PowerPoint) and MS Project.
Benefits
- Eligible for annual short-term incentive (e.g., bonus) and annual long-term incentive (e.g., equity).
- Comprehensive benefits including medical/dental/vision, life/disability insurance, lifestyle reimbursement, flexible spending/HSAs, 401(k) with company match, paid time off, wellness days, holidays, and recharge breaks.
Application Instructions
- N/A
Summary of Key Responsibilities
- Lead cross-functional trial teams to develop and execute study operational plans and ensure end-to-end trial execution.
- Accountable for trial-level delivery: timelines, budget management, quality oversight, key milestones, and critical deliverables.
- Oversee CRO/vendor selection, onboarding, contracting, budget management, performance monitoring, and issue resolution.
- Proactively identify and mitigate operational risks; ensure deliverables and milestones meet corporate and study goals.
- Ensure trial is operationalized in compliance with global health authority regulations/guidelines and internal operating procedures.
- Participate in Health Authority Inspections and internal QA audits; maintain inspection-readiness with R&D Quality.
- Drive continuous improvement in study execution, operational efficiency, quality, and cross-functional collaboration.
- Mentor and support onboarding/development of Study Management colleagues.
- Interface with key internal stakeholders (e.g., Finance, Program Management, Safety, Quality Assurance, Data Management, Statistics, Clinical Research, Regulatory, etc.), acting as a liaison when needed.
- Provide budget variance analysis (budget vs. actual) and notify finance of projected over/under spend.
- Prepare operational updates, risks, and recommendations for governance and leadership forums.
- Travel ~10% (flexible per business need).
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, including Phase 3 registrational experience.
- Experience managing global trials outsourced to a CRO.
- Strong decision-making, analytical, financial, leadership, organizational, and problem-solving skills.
- Demonstrated success leading cross-functional teams in global matrix organizations; results through influence.
- Experience mentoring/coaching.
- Strong project planning/management and communication (written/verbal) and presentation skills.
- Proficient with MS Office (Excel, Word, PowerPoint) and MS Project.
Benefits
- Eligible for annual short-term incentive (e.g., bonus) and annual long-term incentive (e.g., equity).
- Comprehensive benefits including medical/dental/vision, life/disability insurance, lifestyle reimbursement, flexible spending/HSAs, 401(k) with company match, paid time off, wellness days, holidays, and recharge breaks.
Application Instructions
- N/A