Regional Clinical Trial Management Associate

🔥 43 minutes ago

🇮🇹 Italy – Remote

💵 €37k - €46.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Clinical Trial Associate

👻 Ghost score 1%

infoinfo
Apply Now
Find Similar Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Logo of BeOne Medicines

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

• Support the Regional Clinical Study Manager in regional study delivery, ensuring delegated clinical study components meet quality, timeline, and budget expectations • Support feasibility assessment, study start-up, document generation and review, sample tracking, and participant enrollment • Interpret and implement clinical research regulations and ICH guidelines • Support regional team meeting setup and logistics • Collaborate with the Regional Clinical Study Manager, Global Study Management Associate, CRAs, and regional and global stakeholders • Prepare monitoring visit materials and file documents in the TMF • Create and maintain regional/country SharePoint folders and study distribution lists • Set up and maintain countries and sites in eTMF, CTMS, and other systems • Support system access requests and user account management • Assist with local adaptation and review of study-related documents • Support regional/country study start-up and investigator meetings • Create, maintain, review, and quality-check country/site-level TMF documents • Resolve regional/country clinical supply issues with stakeholders • Support data cleaning and follow-up of outstanding information • Prepare site newsletters and study correspondence • Assist with routine study questions from clinical trial sites • Support maintenance of regional/country information in public registries such as CT.gov • Provide regional/country information for Clinical Study Reports • Support operational risk identification, quality assurance audits, inspections, process improvements, local/regional tools, work instructions, and SOPs • Support regional vendor setup and regional study budget and purchase order management

🎯 Requirements

• Bachelor’s Degree in a scientific or healthcare discipline required • Higher Degree preferred • Exceptions might be made for candidates with relevant clinical operations experience • MS Office • Knowledge of clinical operations methodologies and understanding of operational aspects of clinical study processes • 1 or more years of experience in clinical research within biotech, pharma or CRO industry • Limited travel might be required

Apply Now