Study Start-Up Specialist

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Conduct study start-up activities in Germany and Austria and provide local expertise • Identify gaps and areas for improvement and propose CAPA • Collaborate with the Regional Clinical Study Manager/Start-up Lead to meet study timelines and quality standards • Provide country-specific study start-up expertise and support budget and contract negotiations • Follow or support AMG and GCP-V requirements under German and Austrian laws • Retrieve essential documents from study sites and perform essential document site file reconciliation • Review submission packages and submit them to Ethics Committees and Health Authorities or support CTIS submissions • Review and translate drug labels, ICFs, site-specific recruitment materials, and other applicable documents • Track regulatory submissions and milestones to manage site performance • Ensure inspection readiness of study and site start-up documentation • Collaborate with study managers, start-up leads, and clinical study sites to deliver milestones on time • Evaluate site practices and escalate quality or GCP issues • Anticipate and identify site issues, propose corrective and preventative actions, and identify gaps • Support operating excellence, innovation, and process improvement initiatives

🎯 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 with ability to prioritize and multitask • Fluent German required • English writing and speaking skills • Proficiency in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook • Willingness to travel up to 15%

🏖️ Benefits

• Remote work arrangement • Equal opportunity employment