# Senior Manager, Study Management & Outsourcing (Canada)

Hiring organization: [Moderna](https://career.thegoodapps.co/organizations/moderna)

Canonical page: https://career.thegoodapps.co/jobs/85406888-3b95-404c-8204-5b62f37df6a5

Listed on Moderna's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior

## Summary

Lead sponsor-side oversight of nonclinical studies at Moderna's Canadian operations, managing GLP and non-GLP research from protocol development through final reporting. This role suits experienced study managers and monitors in the biopharmaceutical sector who can manage complex outsourced research programs, work with CROs, and drive regulatory compliance across a matrixed organization.

_Our summary, not Moderna's wording._

## Skills named

Data Integrity, Pathology

## Required

- Bachelor's degree in toxicology, pharmacology, or related biological science with 7+ years nonclinical drug development experience, OR Master's with 5+ years, OR PhD with 3+ years
- Sponsor-side study monitor or manager experience with GLP and non-GLP nonclinical studies
- Working knowledge of GLP regulations and global nonclinical regulatory guidance (ICH, FDA, EMA)
- Experience managing CRO partnerships including protocol development, oversight, and report review
- Understanding of end-to-end nonclinical study conduct including protocol development, test article handling, in-life procedures, pharmacokinetic integration, pathology evaluation, and report finalization
- Ability to manage multiple complex studies simultaneously in a matrixed environment
- Strong analytical, organizational, and communication skills with attention to detail
- Ability to influence cross-functional stakeholders without direct authority
- Capacity to work independently in a remote or hybrid environment with sound professional judgment
- Ability to adapt quickly to new data and changing strategic directions

Apply on Moderna's site: https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx/job/Remote---Canada/Senior-Manager--Study-Management---Outsourcing--Canada-_R19436