Alnylam Pharmaceuticals
Global Study Lead
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The Global Study Lead (Sr. Manager, Clinical Operations)
The Global Study Lead (Sr. Manager, Clinical Operations) is responsible for leading the operational planning and execution of global clinical trials from study start-up through closeout. This role provides leadership to cross-functional trial teams, ensuring trial objectives are achieved on time, within budget, and in compliance with applicable regulations, Good Clinical Practice (GCP), and company procedures. The Sr. Manager identifies and mitigates operational risks, drives alignment across stakeholders, and delivers high-quality trial execution in support of development program goals.
This is a hybrid role based in Maidenhead. However, for exceptional candidates, remote working arrangements may also be considered.
Summary Of Key Responsibilities
- Lead cross-functional trial teams to develop and execute study operational plans and deliver successful end-to-end trial execution.
- Accountable for trial-level delivery, including timelines, budget management, quality oversight, key milestones, and critical study deliverables.
- Oversee CRO and vendor selection, onboarding, contracting, budget management, performance monitoring, and issue resolution to ensure successful study delivery.
- Proactively identify operations risks and ensure that trial deliverables and milestones are met according to corporate and study-level goals.
- Identify risks and ensure mitigations and contingencies are being 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.
- Contribute to continuous improvement initiatives by identifying opportunities to enhance study execution, operational efficiency, quality, and cross-functional collaboration.
- Mentor and support onboarding and development of Study Management colleagues, sharing best practices and lessons learned across teams.
- Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
- Provide a variance analysis of budget to actual and notify finance of projected cost over/under expenditure.
- Prepare and provide operational updates, risks, and recommendations to governance forums, leadership teams, and cross-functional stakeholders.
- Ability to travel approximately 10% but flexibility to go over or below as per business need.
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Qualifications
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- BS/ BA degree is required.
- Minimum 7+ years of clinical research experience gained 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 with experience in conducting Phase 3 registrational trials.
- Experience leading global trials outsourced to a CRO and ability to manage all aspects of execution of a clinical trial.
- Excellent decision-making, analytical and financial management skills are essential to this position.
- Excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision.
- Demonstrated success leading cross-functional teams in global matrix organizations and achieving results through influence.
- Experience mentoring/ coaching others.
- Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
- Strong project planning/ management, communication (written and verbal) and presentation skills.
- Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
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