Manager, Clinical Operations
Alnylam Pharmaceuticals, Cambridge, MA, United States
Overview
The Manager, Clinical Operations is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting, risk reviews, and country challenges that could impact overall study delivery.
Summary of Key Responsibilities
Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies
Provide input into global subject/patient recruitment plans.
Relationship management between study sites and vendors
Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight.
Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
Create and update critical trial-specific documents (for example country specific ICF) and plans
Support development of compound and protocol level training materials
Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level
Participate in process improvement activities at a trial and department level as needed
Support onboarding of new team members
Attend CTWG and provide input and updates on operational activities and progress
Ability to travel (approximately10% but flexibility to go over or below as per business need.
Qualifications
BS/ BA Degree is required.
5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials.
2-3+ years leading aspects of global clinical trials
Experience working with a CRO
Strong regulatory knowledge, including Good Clinical Practices (GCPs)
Strong decision-making, analytical and financial management skills are essential to this position
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
Experience with protocol, ICF, CRF, CSR development and review.
Proficient with MS Office Suite (Excel, Word and PowerPoint)
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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: 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.
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The Manager, Clinical Operations is responsible for the execution of study-level activities including but not limited to creating and updating trial-specific documents, vendor oversight & delivery, compound training and country and regional oversight of CRO operational delivery. This includes alignment on the feasibility strategy, target setting, risk reviews, and country challenges that could impact overall study delivery.
Summary of Key Responsibilities
Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies
Provide input into global subject/patient recruitment plans.
Relationship management between study sites and vendors
Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight.
Manage strategic study operations including: study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.
Create and update critical trial-specific documents (for example country specific ICF) and plans
Support development of compound and protocol level training materials
Review and provide input into budgets, timelines, and forecasts for assigned clinical studies
Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level
Participate in process improvement activities at a trial and department level as needed
Support onboarding of new team members
Attend CTWG and provide input and updates on operational activities and progress
Ability to travel (approximately10% but flexibility to go over or below as per business need.
Qualifications
BS/ BA Degree is required.
5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials.
2-3+ years leading aspects of global clinical trials
Experience working with a CRO
Strong regulatory knowledge, including Good Clinical Practices (GCPs)
Strong decision-making, analytical and financial management skills are essential to this position
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
Experience with protocol, ICF, CRF, CSR development and review.
Proficient with MS Office Suite (Excel, Word and PowerPoint)
#
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: 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.
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