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:
The Senior Startup Specialist will be responsible for managing and coordinating all activities related to the startup of clinical trials at multiple sites.
This role is crucial to ensure that trials are initiated efficiently and meet regulatory and quality requirements.
Essential Functions of the job:
Plan, coordinate, and oversee the start-up process of clinical studies, ensuring that deadlines are met and quality standards are upheld. Collaborate with the Regional Submission Lead to ensure the timely delivery of start-up milestones.
Provide country-specific study start-up expertise, assist in start-up activities, and provide support in budget and contract negotiations
Review, manage, and translate the Informed Consent Form, adapting the Study template to Country requirements.
Work closely with investigators, physicians, and other research team members to retrieve essential documents from study sites and perform essential document site file reconciliation
Perform independent quality review of submission packages, submit package to EC (and HA), if required,
Review and translate site-specific recruitment materials and other applicable documents.
Oversee and execute amendments to study protocols during the lifecycle of the study, ensuring timely communication and compliance with regulatory requirements
Ensure inspection readiness of start-up study and site documentation.
Evaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.
Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question the status quo, and promote innovation.
Manage and coordinate the startup activities specific to In Vitro Diagnostic Regulation (IVDR) studies, ensuring compliance with relevant regulations and standards, if applicable.
Notify HAs of the study's conclusion and other required milestones as mandated.
Supervisory Responsibilities:
Mentor and manage junior SSU staff.
Acts as the escalation point person for SSUS(s) with site-related issues and concerns.
May serve as subject matter expert for clinical operations, country regulations and SSU-related activities
Education Required:
Bachelor's degree in Life Sciences, Pharmacy, Biomedicine, or a related field (*exceptions might be made for candidates with relevant clinical operations experience)
Minimum of 5 years of experience in the pharmaceutical industry, preferably in a startup role
Solid understanding of regulatory processes and compliance in clinical research.
Computer Skills: Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Other Qualifications:
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English and Italian
Travel: Travel might be required as per business need
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.
Top Skills
What We Do
BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 8,500 colleagues spans five continents, with administrative offices in Beijing, China; Cambridge, U.S.; and Basel, Switzerland. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
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