Clinical Trial Manager, Clinical Operations, Infectious Disease

Moderna; Toronto; On-site; CAD 95,000 - 130,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being resources

Family building benefits

Generous paid time off

Savings and investments

Job summary

Moderna is expanding its presence in Toronto and seeking a Clinical Trial Manager to oversee operational execution of global infectious disease studies. You will partner with internal teams, investigators, vendors and CROs to deliver trials on time, with quality and regulatory compliance.

You will bring 5+ years of clinical trial coordination experience, an advanced or science-related degree, and strong project management, communication, and cross-functional collaboration skills to drive

Qualifications

• At least five years of clinical trial coordination experience within a clinical research and industry environment.
• Experience supporting global clinical trials and knowledge of FDA regulations and ICH-GCP guidelines.
• Excellent written and verbal communication with ability to collaborate across multidisciplinary teams.
• Strong organizational skills with attention to detail in a fast-paced environment.

Responsibilities

• Provide day-to-day operational management of assigned clinical trial(s).
• Monitor study timelines, risks, and deliverables with internal project teams.
• Lead feasibility activities to support study start-up.
• Coordinate with Clinical Operations Lead and other Clinical Trial Managers to execute studies.
• Develop site-facing materials and training documents.
• Monitor clinical data entry and readiness for data review meetings.
• Review monitoring reports and support appropriate follow-up actions.
• Ensure samples are prepared and transferred to external vendors per timelines.
• Maintain key clinical trial metrics for oversight and performance.
• Ensure trials comply with Moderna quality standards, ICH-GCP, and regulatory requirements.
• Support UAT and testing for clinical trial systems and databases.

Skills

Clinical trial coordination

Project management

Communication skills

Cross-functional collaboration

Attention to detail

Education

Advanced degree preferred

Bachelor's degree in a science-related discipline

Job description

The Role:

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.

Moderna is strengthening its presence in Toronto, a leading biotech hub in Canada. Our team drives commercial operations to bring our mRNA medicines to patients nationwide. We welcome global talent ready to help transform medicine and improve lives.

As a Clinical Trial Manager within our Infectious Disease Clinical Operations team, you will play a critical role in delivering high-quality global clinical trials that advance Moderna's innovative mRNA pipeline. Working as an individual contributor, you will oversee the operational execution of assigned studies, ensuring clinical trial activities are delivered with excellence in quality, compliance and speed while partnering closely with internal teams, investigative sites, vendors and Contract Research Organizations (CROs).

This role offers the opportunity to combine strong clinical operations expertise with outstanding project management and stakeholder collaboration skills. You'll help drive operational excellence across multiple studies while working with modern digital platforms and emerging Generative AI-enabled technologies that continue to enhance clinical trial execution, operational insights and data-driven decision making.

Here's What You'll Do:

• Provide day-to-day operational management of assigned clinical trial(s), ensuring deliverables are achieved across all phases of study execution.
• Monitor study timelines and communicate progress, risks and deliverables effectively with internal project teams.
• Lead and manage clinical trial feasibility activities to support successful study start-up.
• Partner closely with the Clinical Operations Lead and other Clinical Trial Managers to execute global clinical studies.
• Develop site-facing materials, including investigator training materials, study manuals and supporting documentation.
• Monitor clinical data to ensure timely data entry and readiness for data review meetings.
• Conduct periodic reviews of clinical data to support study quality and operational oversight.
• Review clinical monitoring reports to ensure timely completion, identify emerging issues and support appropriate follow-up actions.
• Ensure clinical trial samples are prepared and transferred to external vendors in alignment with study timelines and operational requirements.
• Maintain key clinical trial metrics to support study oversight and performance monitoring.
• Ensure assigned clinical trials are conducted in accordance with Moderna quality standards, ICH Good Clinical Practice (ICH-GCP) guidelines and applicable regulatory requirements across global regions.
• Support User Acceptance Testing (UAT) and testing activities for clinical trial systems and databases.
• Provide support for additional clinical trials in an unblinded Clinical Trial Manager capacity when required.
• Build and maintain strong collaborative relationships with key stakeholders across Moderna, external vendors, CROs and investigator sites.

Here's What You'll Bring to the Table:

• At least five years of clinical trial coordination experience within a clinical research and industry environment.
• Advanced degree preferred, or Bachelor's degree in a science-related discipline.
• Experience supporting clinical trials within a global operating environment.
• Solid understanding of drug development and clinical trial execution.
• Strong project management skills with the ability to manage multiple priorities effectively.
• Good understanding of FDA regulations and ICH-GCP guidelines to ensure the compliant conduct of global clinical studies.
• Excellent written and verbal communication skills with the ability to collaborate effectively across multidisciplinary teams.
• Strong organisational skills, attention to detail and the ability to deliver high-quality work within a fast-paced environment.

As part of Moderna's commitment to build a sustainable workforce, a minimum of 2 years of work authorization is required for this role.

The key Moderna Mindsets you'll need to succeed in the role:

• "We act with urgency; Action today compounds the lives saved tomorrow."
• "We remove viscosity to encourage collective action."

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That's why our global 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 building benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the futur