
10,000+ employees
Founded 2010
đ§Ź Biotechnology
đĽ Healthcare
đ 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.
đĽ 18 minutes ago
đŠđŞ Germany â Remote
đľ âŹ55.1k - âŹ68.9k / year
â° Full Time
đ˘ Junior
đĄ Mid-level
đŹ Research Analyst
đŁď¸đŠđŞ German Required
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10,000+ employees
Founded 2010
đ§Ź Biotechnology
đĽ Healthcare
đ 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.
⢠Execute clinical monitoring activities at clinical trial sites in accordance with ICH guidelines, GCP, local regulations, and SOPs ⢠Perform feasibility, site identification, selection, and evaluation ⢠Support site recruitment targets and provide protocol and study training ⢠Conduct pre-study, initiation, routine monitoring, closeout, and co-monitoring visits as required ⢠Complete monitoring visit reports ⢠Manage site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution ⢠Communicate site progress, issues, and proposed actions to Clinical Operations ⢠Ensure inspection readiness of studies and sites ⢠Collaborate with the Regional Clinical Operations Manager and clinical sites to deliver study milestones ⢠Facilitate study oversight visits, site audits, and inspections as required ⢠Evaluate site practice quality and integrity, escalating quality or GCP issues ⢠Identify site issues, propose corrective and preventative actions, and identify improvement opportunities ⢠Promote operating excellence and innovation
⢠BS in a relevant scientific discipline ⢠Minimum 2 years of clinical monitoring experience ⢠At least 2 years of CRA monitoring experience in the pharmaceutical or CRO industry ⢠Experience in oncology global trials preferred ⢠Experience in oncology/hematology trials preferred ⢠Thorough knowledge of clinical trial processes, ICH, and associated regulatory guidelines ⢠Excellent communication and interpersonal skills ⢠Excellent organizational skills and ability to prioritize and multitask ⢠Fluent in English and German, written and spoken ⢠Efficient in Microsoft Word, Excel, MS Project, PowerPoint, and Outlook ⢠Willingness to travel up to 60%
⢠Remote work arrangement ⢠Equal opportunity employment
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