Cross-Functional Study Orchestrator

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

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