Alnylam Pharmaceuticals
Senior Manager Clinical Operations
Alnylam Pharmaceuticals, Cambridge, Massachusetts, us, 02140
Senior Manager Clinical Operations
Alnylam Pharmaceuticals
Overview
The Sr. Manager, Clinical Operations is accountable for the end‑to‑end clinical trial delivery, providing operational leadership and oversight of cross‑functional deliverables and leading a cross‑functional trial team to build and deliver the trial operational plan. This role is responsible for identifying and mitigating risks to effectively deliver assigned trials on time, within budget, and in a compliant manner.
Summary of Key Responsibilities
Lead the cross‑functional trial team to influence and execute the operational plan and to manage end‑to‑end trial execution.
Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL/CSR/TLR planning and scope, define protocol deviations and resolution pathways).
Oversee all aspects of CRO/vendor identification, set‑up, statement of work creation, budget oversight and performance (KPIs and metrics).
Proactively ensure that trial deliverables and milestones are met according to corporate and study‑level goals.
Identify risks and ensure mitigations and contingencies are initiated and followed through.
Ensure trial is operationalized in compliance with global health‑authority regulations and guidelines and internal operating procedures and processes.
Participate in preparation for, and conduct of, Health‑Authority inspections and internal QA audits.
Ensure that the trial team operates in a constant state of inspection‑readiness, collaborating with R&D Quality to ensure quality oversight.
Participate in process‑improvement activities at the trial and department level as needed.
Mentor and support onboarding of new team members, particularly those in Study Management.
Interface with internal key stakeholders, including Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio‑analytical, Medical Affairs (acting as liaison between groups).
Provide a variance analysis of budget to actual and notify finance of projected cost over/under‑expenditure.
Support and provide input into internal governance presentations and updates.
Ability to travel approximately 10%, with flexibility to go above or below as business needs dictate.
Qualifications
BS/BA degree required.
Minimum 7+ years of clinical research experience with a CRO, Biotech, or Pharmaceutical company working on Phase 1‑4 global clinical trials.
3‑5 years leading end‑to‑end global clinical trials, including Phase 3 registration trials.
Experience leading global trials outsourced to a CRO and managing all aspects of trial execution.
Excellent decision‑making, analytical, and financial management skills.
Excellent leadership skills with proven ability to foster team productivity and cohesiveness and to operate and execute with limited supervision.
Experience leading without authority in multifunctional, matrixed, and global environments.
Experience mentoring/coaching others.
Exceptional organizational skills and ability to deal with competing priorities, strong reasoning and problem‑solving ability.
Strong project planning/management, communication (written and verbal), and presentation skills.
Proficiency with MS Office Suite (Excel, Word, PowerPoint) and MS Project.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Project Management
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Overview
The Sr. Manager, Clinical Operations is accountable for the end‑to‑end clinical trial delivery, providing operational leadership and oversight of cross‑functional deliverables and leading a cross‑functional trial team to build and deliver the trial operational plan. This role is responsible for identifying and mitigating risks to effectively deliver assigned trials on time, within budget, and in a compliant manner.
Summary of Key Responsibilities
Lead the cross‑functional trial team to influence and execute the operational plan and to manage end‑to‑end trial execution.
Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL/CSR/TLR planning and scope, define protocol deviations and resolution pathways).
Oversee all aspects of CRO/vendor identification, set‑up, statement of work creation, budget oversight and performance (KPIs and metrics).
Proactively ensure that trial deliverables and milestones are met according to corporate and study‑level goals.
Identify risks and ensure mitigations and contingencies are initiated and followed through.
Ensure trial is operationalized in compliance with global health‑authority regulations and guidelines and internal operating procedures and processes.
Participate in preparation for, and conduct of, Health‑Authority inspections and internal QA audits.
Ensure that the trial team operates in a constant state of inspection‑readiness, collaborating with R&D Quality to ensure quality oversight.
Participate in process‑improvement activities at the trial and department level as needed.
Mentor and support onboarding of new team members, particularly those in Study Management.
Interface with internal key stakeholders, including Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio‑analytical, Medical Affairs (acting as liaison between groups).
Provide a variance analysis of budget to actual and notify finance of projected cost over/under‑expenditure.
Support and provide input into internal governance presentations and updates.
Ability to travel approximately 10%, with flexibility to go above or below as business needs dictate.
Qualifications
BS/BA degree required.
Minimum 7+ years of clinical research experience with a CRO, Biotech, or Pharmaceutical company working on Phase 1‑4 global clinical trials.
3‑5 years leading end‑to‑end global clinical trials, including Phase 3 registration trials.
Experience leading global trials outsourced to a CRO and managing all aspects of trial execution.
Excellent decision‑making, analytical, and financial management skills.
Excellent leadership skills with proven ability to foster team productivity and cohesiveness and to operate and execute with limited supervision.
Experience leading without authority in multifunctional, matrixed, and global environments.
Experience mentoring/coaching others.
Exceptional organizational skills and ability to deal with competing priorities, strong reasoning and problem‑solving ability.
Strong project planning/management, communication (written and verbal), and presentation skills.
Proficiency with MS Office Suite (Excel, Word, PowerPoint) and MS Project.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Project Management
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