Sr. Manager, Study Start Up

Alnylam Pharmaceuticals; United States; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical benefits

Dental & vision

401(k) with match

Paid time off

Wellness days

Recharge breaks

Family resources

Job summary

Alnylam Pharmaceuticals is seeking a Senior Manager, Study Start-up to join our dynamic Clinical Operations team. This role partners with the study team to lead global start-up and site activation activities across Phase I-III trials, coordinating with CROs, vendors, and KOLs to accelerate delivery and enrollment milestones.

You will oversee end-to-end study startup strategy, plans, and timelines, drive data-driven forecasting, mitigate risks, and share best practices across study teams to

Qualifications

• Bachelor’s Degree in Science or related discipline; a higher degree would be desirable.
• 8+ years experience with CRO or biopharmaceutical company on multinational clinical studies.
• 5+ years managing operational aspects of clinical studies.
• Significant experience leading global study start-up and site activation.
• Experience working with external CROs and cross-functional teams.
• Broad-based experience in clinical development including trial conduct, study start-up and feasibility, country and site selection and patient recruitment.
• Knowledge of GCP and understanding of local regulatory requirements.

Responsibilities

• Drive global study start-up and site activation activities, milestone oversight, and CRO delivery.
• Develop and deliver the global study startup plan with the CRO Study Startup team.
• Lead development of procedures to enhance internal startup capabilities and drive efficiencies.
• Guide study teams through startup activities within timelines for predictable delivery.
• Oversee analysis of clinical trial data and its application to startup forecasts.
• Collaborate with Feasibility experts to drive data-driven startup forecasts and planning.
• Develop processes and technologies to ensure ongoing delivery of Study Startup Services.
• Participate in early global strategic study planning to align with corporate goals and CRO commitments.
• Partner with CRO to ensure efficient startup processes and reporting.
• Progress site activations with in-country intel to remove roadblocks.
• Track KPIs and metrics to support process improvement and reporting.
• Maintain startup standards to deliver high quality, compliant studies.
• Build and maintain study startup best practices; support junior staff.

Skills

Global startup leadership

Cross-functional collaboration

Project management

Regulatory knowledge

GCP knowledge

Education

Bachelor’s Degree in Science or related discipline

Advanced degree desirable

Job description

Alnylam Pharmaceuticals is seeking a Senior Manager, Study Start-up to join our dynamic and growing team. The Senior 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 with CRO teams, internal study stakeholders, KOLs, external vendors, and site networks to drive top quality, best in class delivery, acceleration and optimization of study start-up, site activation and enrollment milestones.

The Senior 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 Senior 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 Senior Manager, Study Start-up will serve as an expert across the study start-up, country, and site activation landscape. The Senior 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.

The Snr Manager, Study Start-up excels in project management, organizational, and communication skills to clearly share best practices with study teams, CROs, and internal stakeholders across the Clinical Operations organization to deliver consistent application of these practices.

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.
• Lead development of procedures to enhance internal start-up capabilities and drive efficiencies 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.
• Oversee the analysis of clinical trial data and its application to conduct accurate study startup forecasts.
• Collaborate with internal Feasibility experts to drive rapid, accurate, and data-driven study startup forecasts, benchmarking assumptions, scenarios and accurate planning.
• Develop creative processes, methodologies, data and technologies to ensure ongoing delivery of valued Study Startup Services.
• 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 the recruitment and performance of junior staff; provide guidance for effective prioritization, problem identification and solving resulting in improved strategic drug development operational efficiency

Qualifications

• Bachelor’s Degree in Science or related discipline. A higher degree would be desirable.
• Significant (8+ years) previous experience gained with a CRO or biopharmaceutical company working on multinational clinical studies.
• Considerable (5+ years) managing operational aspects of clinical studies.
• Significant experience in leading global study start-up and site activation activities is required.
• Must have experience working with external CROs and cross functional teams.
• Broad-based experience in clinical development including clinical trial conduct, Study Start-up and feasibility, country and site selection and patient retention and recruitment.
• Knowledge of GCP and a good understanding of the processes associated with clinical operations, study management and monitoring, and local regulatory requirements.

U.S. Pay Range

$140,300.00 - $189,900.00

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

About Alnylam

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.