Senior Clinical Research Associate

🔥 5 minutes ago

🇫🇷 France – Remote

💵 €49.4k - €61.8k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 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

• Execute clinical monitoring activities at clinical trial sites in accordance with ICH guidelines, GCP, local regulations, and SOPs • Monitor oncology/onco-hematology clinical trials through site selection, initiation, conduct, recruitment, data collection, and closeout • Perform onsite and remote pre-study, initiation, routine monitoring, and closeout visits • Conduct co-monitoring visits when required • Provide protocol and study training to assigned sites • Create and maintain site management documentation, visit reports, follow-up letters, and action plans • Track regulatory submissions, recruitment, CRF completion, and data query resolution • Maintain site documents for the Trial Master File and verify Investigator Site File compliance • Ensure study and site inspection readiness • Communicate site progress, issues, risks, and proposed actions to Clinical Operations • Collaborate with Country and Regional Clinical Study Teams to deliver study milestones • Facilitate compliance visits, audits, and inspections • Evaluate site practices and escalate quality or GCP issues • Identify site issues, propose corrective and preventative actions, and promote operational improvement • Mentor junior CRAs and act as an escalation point for site-related issues • Review visit reports and communicate significant risks and proposed actions to Clinical Study Managers • 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 CRA monitoring experience in the pharmaceutical or CRO industry • Equivalent combination of education, training, and experience may be considered • Experience in oncology/onco-hematology global trials preferred • Advanced knowledge of Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and applicable clinical research regulatory requirements • 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 French • Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, laptop computers, and iPhone • Willingness and ability to travel up to 75–80%

🏖️ Benefits

• Equal opportunity employment • Professional training in therapeutic, protocol, clinical research, and CRA procedures • Mentoring and experience development with experienced clinical staff