Study Start-Up Specialist

🕒 Yesterday

🇩🇪 Germany – Remote

💵 €55.1k - €68.9k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👻 Ghost score 0%

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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

• 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%