Study Start-Up Specialist
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Job Description
Study Start-Up Specialist supporting BeOne’s oncology clinical-trial activation across Germany and Austria. Managing regulatory submissions, site documentation, contracts, and start-up milestones.
Responsibilities:
- Responsible for start-up activities in Germany and Austria and provides local expertise
- Identify gaps and areas for improvement and propose CAPA
- Collaborate with the Regional Clinical Study Manager/Start-up Lead to ensure study timelines and quality standards
- Provide country-specific study start-up expertise and support budget and contract negotiations
- Follow or support AMG or GCP-V requirements under German/Austrian laws
- Retrieve essential documents and perform essential document site file reconciliation
- Perform independent quality review of submission packages and submit packages to EC/HA or support CTIS submission
- Review and translate drug labels, ICF, site-specific recruitment materials, and other applicable documents
- Manage sites and site performance by tracking regulatory submissions and milestones
- Ensure inspection readiness of start-up study and site documentation
- Collaborate with clinical study sites to deliver start-up milestones on time
- Evaluate site practices and escalate quality or GCP issues
- Anticipate and identify site issues; propose corrective and preventative actions
- Initiate, support, or lead process improvement initiatives
- Promote operating excellence, innovation, and continuous improvement
Requirements:
- BS or equivalent in a relevant scientific discipline
- Experience in oncology global trials preferred
- Thorough knowledge of clinical trial processes, ICH, and associated regulatory guidelines
- 2-5 years of Start-up experience in the pharmaceutical or CRO industry
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multitask
- Fluent in German
- English writing and speaking
- Proficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook
- Willingness to travel up to 15%
Benefits:
- Equal opportunity employment
- Travel up to 15%
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