Clinical Trial Manager, Clinical Operations, Infectious Disease

Joining Moderna means advancing mRNA science to transform medicine. Moderna is strengthening its presence in Toronto, a leading biotech hub in Canada. 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).

Responsibilities

Provide day-to-day operational management of assigned clinical trials; Monitor study timelines and communicate progress, risks and deliverables; Lead and manage clinical trial feasibility activities; Partner with Clinical Operations Lead and other Clinical Trial Managers; Develop site-facing materials; Monitor clinical data to ensure timely data entry and readiness for data review meetings; Conduct periodic reviews of clinical data; Review clinical monitoring reports; Ensure clinical trial samples are prepared and transferred to external vendors; Maintain key clinical trial metrics; Ensure assigned clinical trials are conducted in accordance with Moderna quality standards, ICH-GCP guidelines and applicable regulatory requirements; 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, external vendors, CROs and investigator sites

Requirements

At least five years of clinical trial coordination experience within a clinical research and industry environment; 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; 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; Minimum of 2 years of work authorization required

Nice to have

Advanced degree

Benefits

Competitive healthcare; Voluntary benefit programs; 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 discretionary year-end shutdown; Savings and investments; Location-specific perks and extras; Annual discretionary bonus, other incentive compensation, or equity award