Senior Manager, Study Management & Outsourcing (Canada)

Location: Remote - Canada

Company

hirify.global develops mRNA medicines and operates a technology platform focused on transforming how medicines are created and delivered.

What you will do

• Lead sponsor-side oversight of GLP and non-GLP nonclinical studies from protocol development through final report.
• Own study quality, timelines, budgets, deliverables, operational execution, and outcomes across multiple complex programs.
• Partner with Canada-based CROs, negotiate Statements of Work, monitor performance, manage risks, and drive issue resolution.
• Review protocols, amendments, emerging data, deviations, interim analyses, scientific findings, and final study reports.
• Coordinate Toxicology, DMPK, Pathology, Bioanalytical, Program Management, Therapeutics, and Platform Research stakeholders.
• Maintain audit- and inspection-ready documentation, ensure data integrity, conduct site visits as needed, and mentor colleagues.

Requirements

• Bachelor’s degree in toxicology, pharmacology, biological sciences, or a related discipline with 7+ years of relevant experience; alternatively, a Master’s degree with 5+ years or a PhD with 3+ years in pharmaceutical or biotechnology industry experience.
• Experience as a sponsor-side Study Monitor or Study Manager supporting nonclinical GLP and/or non-GLP studies.
• Strong knowledge of GLP regulations and global nonclinical guidance, including ICH, FDA, and EMA expectations.
• Experience managing CRO partnerships, including protocol development, study oversight, issue resolution, and report review.
• Operational understanding of nonclinical drug development, including test article handling, in-life procedures, pharmacokinetic and bioanalytical integration, pathology evaluation, data review, and report finalization.
• Ability to manage multiple complex workstreams, influence stakeholders without direct authority, and work independently in a remote or hybrid environment.

Culture & Benefits

• Work with global, multidisciplinary teams advancing mRNA science and medicines.
• Healthcare and voluntary benefit programs, fitness and mindfulness resources, and mental health support.
• Family-building benefits covering fertility, adoption, and surrogacy support.
• Paid vacation, bank holidays, volunteer days, sabbatical leave, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs, plus location-specific perks and extras.
• hirify.global promotes an in-person culture through a company-wide 70/30 work model; this role is listed as remote in Canada.