Senior Manager, Clinical Operations

Senior Manager, Clinical Operations

Overview

The Senior 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.

Key Responsibilities

• Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for 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).
• Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s 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 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
• Participate in process improvement activities at a trial and department level as needed.
• Mentor & support onboarding of new team members, particularly those in Study Management.
• 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.
• Support and provide input into internal governance presentations & updates
• Ability to travel approximately 10% but flexibility to go over or below as per business need).

Qualifications

• 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
• Experience in leading without authority and in multifunctional matrixed and global environments
• 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.

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.