Senior Study Start-Up Specialist
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Posted by BeOne Medicines (Canada) ULC on the hiring system it uses for its careers page; applications go straight to the company.
Can I apply?
- Full-time
- Remote from Canada
- Work permit not stated
Senior remote role in Canada for study start-up and submissions (site activation, ICF, central IRB, CTMS/eTMF) under ICH/GCP.
Requires at least 3 years of progressive clinical research/operations experience; a science or healthcare bachelor's degree is preferred, not required.
Salary listed as 76,000–95,000 CAD with no pay period stated.
Posted as full-time; no work authorization or security clearance requirements are stated.
From the posting
- workplace
ATS location says remote: Canada Remote
- locations
ATS location: Canada Remote
- remote eligible countries
Canada Remote
- employment types
full_time
- salary
76,000.00 CAD - 95,000.00 CAD
- seniority
Senior Study Start-Up Specialist
- job function
Responsible for the delivery of study start-up, initial and ongoing submissions
- role family
Minimum of 3 years of progressive experience in clinical research and clinical operations
- skills
Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
- skills
Complete SSU data entry in CTMS
- skills
Complete timely and quality eTMF filing
- years experience min
Minimum of 3 years of progressive experience in clinical research and clinical operations
- education required
Bachelor’s degree or higher in a scientific or healthcare discipline preferred
- actionable
Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines
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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