Senior Clinical Research Associate

🕒 October 20

🇩🇪 Germany – Remote

💵 €66.2k - €82.8k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Execute clinical monitoring activities at clinical trial sites in accordance with ICH guidelines, GCP, local regulations, and SOPs • Perform site selection and evaluation and support recruitment targets • Provide protocol and study training to assigned sites • Conduct onsite and remote pre-study, initiation, routine monitoring, and closeout visits • Conduct co-monitoring visits when required • Prepare visit reports, follow-up letters, action plans, and other study documentation • Manage site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution • Maintain Trial Master File and Investigator's Site File documentation and ensure inspection readiness • Report site progress, issues, and proposed actions to Clinical Operations • Collaborate with Country and Regional Clinical Study Managers and clinical study sites to deliver study milestones • Facilitate compliance visits, site audits, and inspections • Evaluate site quality and integrity and escalate GCP issues • Identify site issues, propose corrective and preventative actions, and promote operational excellence • Mentor junior staff and act as escalation point for site-related issues • Review visit reports, follow up on issue resolution, and communicate significant risks and proposed actions • Serve as a subject matter expert for clinical operations, country regulations, and monitoring activities when assigned

🎯 Requirements

• BS in a scientific or healthcare discipline preferred • At least 3–5 years of monitoring experience • 5+ years of CRA monitoring experience in the pharmaceutical or CRO industry • Equivalent combination of education, training, and experience may be considered • Advanced knowledge of applicable clinical research regulatory requirements, including GCP and ICH guidelines • Experience in oncology/onco-hematology trials preferred • Excellent communication and interpersonal skills • Ability to establish and maintain effective working relationships with coworkers, managers, and internal/external stakeholders • Excellent organizational and problem-solving skills; ability to prioritize and multitask • Effective time management skills • Good command of English and German • Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, laptop computer, and iPhone • Willingness to travel up to 80%

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