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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

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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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

Categories

  • Healthcare
  • Science & Research

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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