BeOne Medicines
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.
Study Start-up Specialist
🔥 2 hours ago
🗣️🇳🇱 Dutch Required
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BeOne Medicines
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
• Responsible for study start-up activities in the Netherlands and provides local expertise • Identify gaps and areas for improvement and propose CAPA • Collaborate with the Regional Clinical Operations Manager/Start-up Lead to adhere to study timelines and maintain quality standards • Provide country-specific study start-up expertise and assist with start-up activities • Support budget and contract negotiations • Retrieve essential documents from study sites and perform essential document site file reconciliation • Perform independent quality reviews of submission packages and submit packages to EC and HA when required • Review and translate drug labels, ICFs, site-specific recruitment materials, and other applicable documents • Manage sites and site performance by tracking regulatory submissions and relevant milestones • Ensure inspection readiness of start-up study and site documentation • Collaborate with the Regional Clinical Operations Manager/Start-up Lead and clinical study sites to deliver start-up milestones on time • Evaluate the quality and integrity of site practices and escalate quality or GCP issues as appropriate • Anticipate and identify site issues, propose corrective and preventative actions, identify gaps, and utilize opportunities • Strive for operating excellence, challenge the status quo, and promote innovation
🎯 Requirements
• BS in a relevant scientific discipline • 1–2 years of start-up experience • Experience in oncology global trials preferred • Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook • Thorough understanding of clinical trial processes • Thorough knowledge of ICH and associated regulatory guidelines • 1–2 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 English and Dutch, in writing and speaking
🏖️ Benefits
• Remote work in Denmark • Travel up to 15%
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