Integrated Study Coordinator

VitalBio; Oakville; On-site; CAD 110,000 - 160,000; Full time

Job summary

Vital Biosciences Inc. in Ontario, Canada, seeks a highly organized, cross-functional liaison to bridge assay, software, hardware, consumable, and manufacturing teams.

You will plan and execute studies across the medical device development lifecycle, from design characterization through V&V and preclinical phases, coordinating builds, reagents, data, and documentation. You will author protocols and study reports, manage training and qualification of staff, and ensure compliance with CLSI

Qualifications

• Bachelor's or Master's degree in a life science, biomedical/engineering, or related field; equivalent experience considered.
• 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.

Responsibilities

• 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.

Skills

Cross-functional coordination

Technical writing

Regulatory experience

Jira

eQMS

SOP management

Life sciences background

Program management

Communication skills

Education

Bachelor's or Master's in life science/ biomedical/ engineering

Tools

Jira

eQMS

Job description

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.

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-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth‑minded culture empowers front‑line decision‑making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance

As part of our recruitment process, we may use automated or AI-supported tools to assist with application review and screening. These tools are used to support, not replace, human decision‑making. Final hiring decisions are always made by our hiring team.