Manager, Study Start-Up

Alnylam Pharmaceuticals is seeking a Manager, Study Start-up to join our dynamic and growing team.The Manager, Study Start-up partners closely with the Clinical Operations study team leading global study start-up and site activation activities in Phase I-III and real-world evidence clinical trials. This team member will also partner closely CROs, study teams, vendors, and investigative sites to ensure timely, high-quality, and compliant delivery of start-up milestones. The Manager, Study Start-up provides direct oversight, direction, and support beginning with early study planning, country and site selection, data-driven scenario planning, and enrollment forecasting to ensure predictable and consistent delivery. The Manager, Study Start-up will oversee and ensure the delivery of global (end-to-end) study startup activities (strategy, plans, activities, timelines, and synthesis of study startup insights and presentation to study teams) at program/study level.

The Manager, Study Start-Up balances strategic oversight with hands-on responsibilities to ensure predictable delivery of study start-up. This individual will support feasibility, country and site selection, regulatory submissions oversight, site activation deliverables, while driving process improvements and sharing best practices across the organization

The Manager, Study Start-up creates project plans for efficient implementation and oversight of appropriate processes, tools, and technologies to accelerate start-up activities. This candidate leads successful study and site activation oversight by removing complexity, conducting proactive risk mitigation, and removing obstacles for sites to successfully activate within study and corporate objectives.

Key Responsibilities

• Responsible for driving global study start-up and site activation activities, milestone oversight, and CRO delivery.
• Develop and deliver the global study startup plan by partnering with the CRO Study Startup team.
• Drive efficiencies to enhance internal start-up capabilities to align with Trial Delivery Optimization goals.
• Guide study teams through conduct and delivery of key startup activities within timelines that contribute to operational planning/decisions resulting in predictable delivery for achieving R&D goals.
• Collaborate with internal Feasibility experts to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate planning.
• Participate in early, global, strategic study planning to ensure corporate goals and timelines for study start-up and site activation are accurate and achievable; ensure CRO commitment to all study deliverables and timelines.
• Partner with CRO to ensure efficient start-up processes and reporting to deliver best in practice country and site activations.
• Work directly with internal study team members and CRO counterparts to progress site activations efficiently and as per targeted milestones; facilitates timely resolution of site-level issues by utilizing in-country intel and expertise to remove or prevent roadblocks
• Tracks and reports relevant KPIs and metrics including local country and site level cycle times to support process improvement and overall operational/business reporting to accelerate site activation
• Oversee consistent application of appropriate study start-up standards and processes to deliver high quality, cost effective clinical studies in line with local operational, legal and regulatory requirements
• Build and maintain study start-up, country and site activation best practices.
• Support inspection/audit readiness by ensuring compliance with GCP, SOPs, and regulatory requirements.
• Contribute to continuous improvement initiatives, tool/technology adoption, and knowledge sharing to enhance study start-up efficiency

Qualifications

• Bachelor's Degree in Science or related discipline. A higher degree would be desirable.
• 5-7 years of clinical research experience, including direct involvement in leading global study start-up and site activation is required
• Prior experience overseeing CROs on multinational clinical studies
• Working knowledge and strong understanding of study start-up processes: feasibility,
• Knowledge of ICH/GCP, broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment
• Excellent organizational, communication, and problem-solving skills with proven ability to manage competing priorities
• Demonstrated ability to build strong relationships with CROs, vendors, and cross-functional partners

U.S. Pay Range

$126,700.00 - $171,500.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach 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 possibleand 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, wherean authentic, inclusive culture and breakthrough thinkingfuel 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.