Clinical Research Manager

🕒 September 24

🇧🇪 Belgium – Remote

💵 €83.2k - €104k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 2%

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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

• Act as line manager for trial monitoring staff (CRAs) in Belgium • Plan, assign, and direct work; assess performance and guide professional development of direct reports • Participate in hiring selection and allocate resources to clinical research projects • Assign staff to clinical studies based on experience and training • Ensure clinical trial protocols are executed according to ICH/GCP, local regulations, and applicable SOPs • Collaborate with the Regional Clinical Operations Manager to maintain study timelines and quality standards • Support study start-up and provide local expertise • Manage study start-up and trial monitoring staff in accordance with company policies and regulations • Ensure onboarding and training of new employees and oversee training plans • Manage quality of assigned staff's clinical work through regular review and evaluation • Provide country-specific study start-up expertise and review study documents, drug labels, ICFs, and templates • Develop and review site-specific recruitment materials and tools • Collaborate with study teams and clinical sites on IRB/EC submissions, TMF completeness, site activation, enrollment, and inspection readiness • Contribute to feasibility, site identification, selection, and evaluation • Perform accompanied CRA visits and assess performance • Review visit reports, follow up on issue resolution, and communicate significant risks and proposed actions • Monitor workload and quality metrics through regular review and reporting • Anticipate and identify site issues, propose CAPAs, identify gaps, and leverage opportunities • Promote operating excellence and innovation • Contribute to Clinical Operations strategy and performance against key metrics • Mentor and manage junior staff and Clinical Research Associates • Act as escalation point for CRA site-related issues • Conduct mid-year and year-end performance appraisals for direct reports

🎯 Requirements

• Bachelor’s degree (or equivalent) or higher in a scientific, medical or healthcare discipline • Minimum 5-7 years progressive experience in clinical operations within the biotech/pharmaceutical sector • Prior clinical trial experience including experience in a management/leadership capacity • Experience in oncology is highly recommended • Ability to work independently and effectively handle multiple priorities in a fast-paced environment • Minimum 5-7 years progressive experience in clinical operations, preferably including at least 2 years of line management in the pharmaceutical or CRO industry • Excellent interpersonal skills and strong organizational skills • Fluent in German & the country language (writing and speaking) • Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook • Willingness to travel up to 30-40%

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