Senior Study Start-up Specialist

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(