Clinical Trial Manager, Clinical Operations, Infectious Disease

BioSpace; Cambridge (MA); Hybrid; USD 109,000 - 175,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna is seeking a Clinical Trial Manager to provide oversight of assigned trials, ensure quality, compliance, and on-time deliverables, and closely manage external vendors and CROs. You will collaborate with the Clinical Operations Lead and study team, draft site materials, monitor data, and maintain trial metrics across global regions in alignment with FDA/ICH GCP.

The role requires strong project management, excellent communication, and the ability to work across multiple trials in a

Qualifications

• At least 5 years of trial coordination experience in a clinical research and industry environment.
• Advanced degree preferred or Bachelor’s in a science-based subject.
• Relevant experience in global setting.
• Solid understanding of drug development.
• Good project management skills.
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
• Excellent verbal and written communication skills.
• Good organizational skills and attention to detail.

Responsibilities

• Day to day management of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
• Communication to internal team members on deliverables and ensuring timelines are met
• Manage trial feasibility process
• Work closely with study Clinical Operations Lead and/or assigned Clinical Trial Manager(s) to execute clinical studies
• Drafting site materials including training, manuals and support documentation
• Monitoring of clinical data to ensure timely entry and readiness for data review meetings
• Periodic review of clinical data
• Review of clinical monitoring reports to ensure timely completion and identification of issues
• Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
• Maintain trial metrics
• Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials
• Support testing clinical trial systems/databases (i.e. UAT)
• May support additional clinical trial(s) in an unblinded Clinical Trial Manager capacity
• Develop and maintain strong, collaborative relationships with key stakeholders within Moderna

Skills

Trial coordination

Vendor management

Regulatory knowledge

Project management

Communication

Attention to detail

GCP knowledge

Education

Advanced degree preferred

Bachelor's in science

Job description

The Role

The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Director, Clinical Operations and is accountable to the Clinical Operations Lead for assigned studies.This role may work collaboratively on one trial or across several trials to support clinical operations activities.

The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Director, Clinical Operations and is accountable to the Clinical Operations Lead for assigned studies.This role may work collaboratively on one trial or across several trials to support clinical operations activities.

Here’s What You’ll Do

• Day to day management of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
• Communication to internal team members on deliverables and ensuring timelines are met
• Manage trial feasibility process
• Work closely with study Clinical Operations Lead and/or assigned Clinical Trial Manager(s) to execute clinical studies
• Drafting site materials including training, manuals and support documentation
• Monitoring of clinical data to ensure timely entry and readiness for data review meetings
• Periodic review of clinical data
• Review of clinical monitoring reports to ensure timely completion and identification of issues
• Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables
• Maintain trial metrics
• Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials
• Support testing clinical trial systems/databases (i.e. UAT)
• May support additional clinical trial(s) in an unblinded Clinical Trial Manager capacity
• Develop and maintain strong, collaborative relationships with key stakeholders within Moderna

Here’s What You’ll Bring To The Table

• At least 5 five years of trial coordination experience in a clinical research and industry environment
• Advanced degree preferred or Bachelor’s in a science-based subject
• Relevant experience in global setting
• Solid understanding of drug development
• Good project management skills
• Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies
• Excellent verbal and written communication skills
• Good organizational skills and attention to detail

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.Moderna is a place where everyone can grow.

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Accommodations

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].