About you

You are a detail-oriented systems thinker who bridges scientific and engineering disciplines across assay, software, hardware, consumable, and manufacturing perspectives. You focus on the how of inter-team study delivery rather than portfolio-level program management, and you're comfortable acting as the scientific and operational liaison between teams, translating requirements and resolving ambiguity in scope. You bring strong technical writing, communication, and conflict-resolution skills to a hands-on integration and study-execution role.

About you

You are a detail-oriented systems thinker who bridges scientific and engineering disciplines across assay, software, hardware, consumable, and manufacturing perspectives. You focus on the how of inter-team study delivery rather than portfolio-level program management, and you're comfortable acting as the scientific and operational liaison between teams, translating requirements and resolving ambiguity in scope. You bring solid technical writing, communication, and conflict-resolution skills to a hands-on integration and study-execution role.

What you'll do

- Strategize and orchestrate cross-functional handoffs across assay, software, hardware, consumable, and manufacturing teams, defining inputs, outputs, acceptance, and timing for each transfer from Phase II exit through V&V;, preclinical, and beyond.
- Act as the scientific and operational liaison between teams, translating requirements, resolving ambiguity in scope, and ensuring each function understands what it is receiving and what it owes downstream.
- Identify integration points and dependencies that span functional boundaries, designing how data, samples, builds, releases,



and documentation flow between teams to keep studies unblocked.
- Plan studies across the development lifecycle, including design characterization, V&V-readiness;, preclinical analytical and in vivo/model studies, and clinical-pilot preparation.
- Execute studies per approved protocols, coordinating engineering builds, reagents/consumables, software/firmware releases, instrument units, and biological/sample needs with responsible teams.
- Manage samples used for studies, including sourcing, chain-of-custody, storage, tracking, allocation across study arms, and disposition.
- Author and manage study documentation, including study protocols, work instructions, and SOPs, maintaining version control and ensuring teams work to current revisions.
- Author study reports summarizing methods, data, results, deviations, and conclusions against pre-defined acceptance criteria and CLSI method-evaluation protocols.
- Maintain the study documentation set: protocols, deviation logs, test records, operator log, traceability matrices, and design history file (DHF) inputs supporting the transition into V&V; and preclinical evidence.
- Manage operators and the broader study team, coordinating task assignment, training and qualification, scheduling, and performance oversight for study execution activities.
- Surface and resolve cross-functional technical and procedural blockers,



supporting technical troubleshooting, root cause investigations, and system-wide improvements.
- Support design reviews, gating decisions, and risk management activities across the R&D-to-V;&V; transition and preclinical phase.

What you'll need

- Bachelor's or Master's degree in a life science, biomedical/engineering, or related field; equivalent experience considered.
- Prior experience planning, executing, and reporting studies across the medical device development lifecycle, including late-stage R&D;, V&V;, and/or preclinical activities.
- Demonstrated ability to integrate work across scientific and engineering disciplines, bridging assay, software, hardware, consumable, and manufacturing perspective.
- Working knowledge of CLSI guidelines and their application to method evaluation, precision, linearity, and method comparison studies.
- Experience writing and managing SOPs, work instructions, and study protocols in a regulated environment.
- Experience managing operators, technicians, or research staff, including training and qualification.
- Proficiency with requirements management tools (e.g., Jira, eQMS) and Microsoft Office/Google Workspace.
- Strong technical writing, communication, and conflict-resolution skills; detail-oriented with systems thinking.

Compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.

This role is a current, onsite vacancy.

About Vital Bio

Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-ti

📌 Integrated Study Coordinator (Oakville)
🏢 Vital Bio
📍 Oakville