Senior Study Start-Up Specialist

BeiGene; United States; Remote; USD 54,000 - 67,000; Full time

Job summary

BeOne seeks a Clinical Start-Up Specialist to manage site start-up and submission tasks across North America. The role emphasizes ICH/GCP adherence, regulatory compliance, and document management to ensure timely activations.

Responsibilities include coordinating IRB submissions, maintaining CTMS SSU data, and improving start-up processes. A bachelor’s degree and 3+ years in clinical research are required for this position.

Qualifications

• Bachelor’s degree in science or healthcare required or equivalent
• Minimum 3 years in clinical research/clinical operations in biotech/pharma/CRO/site environment
• Familiar with ICH/GCP and local regulations
• Strong document management and negotiation skills

Responsibilities

• Lead site start-up activities and activation timelines
• Manage ICF/submissions and IRB coordination
• Maintain SSU data entry in CTMS and timely eTMF filing
• Support development of local workflows to improve output
• Contribute to SSU infrastructure improvements in North America
• Perform additional tasks to meet project goals

Skills

ICH/GCP knowledge

Regulatory compliance

SOP adherence

CTMS data entry

eTMF filing

Site start-up

Documentation management

Education

Bachelor’s degree in scientific/healthcare discipline

Tools

CTMS

eTMF systems

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.