Senior Clinical Research Associate

🔥 1 hour ago

🇩🇪 Germany – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 Description

• Monitor clinical trials and observational studies for protocol adherence, site activities, data collection, and data integrity • Perform remote and on-site monitoring according to project timelines • Schedule travel and submit expense reports according to UBC policies • Attend project team, department, and manager meetings • Complete site monitoring reports and follow-up letters with minimal corrections • Follow up on site issues and action items within required timelines • Enter site visits, monitoring reports, follow-up dates, and site contacts into the CTMS • Monitor EDC data entry and assist sites with eCRF resolution • Review Investigator Site Files and reconcile Investigational Product • Maintain regular contact with assigned sites • Complete SOP reviews, training assessments, and required documentation • Perform European monitoring activities, including patient information and informed consent review, regulatory submissions, CTIS tracking, ethics committee submissions, contract negotiations, payment confirmation, eTMF maintenance, essential document tracking, and study feasibility assessments • Perform Site Management and Monitoring activities according to project plans and timelines • Assist with other duties as assigned

🎯 Requirements

• Bachelor’s degree – Life Science preferred or equivalent years of industry and clinical research experience • Minimum of 24 months’ clinical research experience, specifically in site management and remote monitoring • Preferably at least 6 months’ on-site monitoring experience • Knowledge of medical terminology and regulatory guidelines, including local legislation • Strong attention to detail and excellent organizational skills • Effective communication, critical thinking, and resolution skills • Ability to deliver accurate work and adhere to deadlines in a fast-paced environment • Good written and verbal communication skills in English and local language, as applicable • Experience with CTMS, eTMF, EDC, and Microsoft Office applications • Willingness/ability to travel up to 50% in the European region

🏖️ Benefits

• Equal opportunity employer committed to a diverse, equitable and inclusive culture • Inclusive workplace that fosters creativity • Career growth and meaningful impact opportunities