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BeOne Medicines

Senior Study Start-Up Specialist

Canada

76,000.00 CAD - 95,000.00 CAD · Full-time

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Job details

Pay: 76,000.00 CAD - 95,000.00 CAD
Job type: Full-time
Experience: Minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.
Posting language: English
Posted: Oct 8, 2026

Original job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description

Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations.

Essential Functions Of The Job

Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
Contribute to discussions during the feasibility state of site selection
Site Start-Up
Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations.
Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
ICF/Submissions
Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
Skilled in document preparation and submission to central IRB to ensure timely reviews.
Ensure collection and review of essential documents
Complete SSU data entry in CTMS
Complete timely and quality eTMF filing
Support in the development of local workflows to streamline output and deliverables.
Contribute to the ongoing improvement of SSU infrastructure in North America
Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals.

Supervisory Responsibilities

Not applicable

Education/Experience Required

Bachelor’s degree or higher in a scientific or healthcare discipline preferred
Minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.

Salary Range Canada

76,000.00 CAD - 95,000.00 CAD

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

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More about this job

Responsibilities

Deliver study start-up and initial and ongoing submissions on time and to a high standard, in compliance with ICH/GCP, company procedures, and local regulations. Coordinate site start-up activities, submissions, essential document management, CTMS data entry, and eTMF filing while helping improve workflows and start-up processes.

Requirements

A bachelor’s degree or higher in a scientific or healthcare discipline is preferred. Candidates should have at least three years of progressive clinical research and clinical operations experience, preferably in biotechnology, pharmaceuticals, a CRO, or a clinical site environment.

Skills

Clinical Research
Clinical Operations
Study Start-Up
Site Selection
Site Activation
Regulatory Submissions
Informed Consent Forms
Document Management
Central IRB Submissions
Essential Document Collection and Review
CTMS Data Entry
eTMF Filing
ICH/GCP Compliance
Local Regulations
Workflow Development
Site Relationship Management

Visa sponsorship

Not detected in the job text

Keywords

Clinical Research
Clinical Operations
Study Start-Up
Site Selection
Site Activation
Feasibility
ICH/GCP
Local Regulations
Standard Operating Procedures
Regulatory Submissions
Informed Consent Forms
Central IRB
Essential Documents
CTMS
eTMF
Document Management
Site Partnerships
Clinical Trials
Biotechnology
Pharmaceuticals
CRO
Workflow Development
Cycle Time Reduction

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