
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 0 minutes ago
đŞđ¸ Spain â Remote
đľ âŹ41.4k - âŹ51.8k / year
â° Full Time
đ˘ Junior
đĄ Mid-level
đ§Ş Clinical Research
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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 and GCP, local regulations, and applicable SOPs ⢠Perform monitoring activities related to selection, initiation, conduct, recruitment, quality data collection, and timely completion of oncology/hematology clinical trials ⢠Collaborate with the Regional Clinical Operations Manager to ensure study timelines and quality standards are maintained ⢠Identify gaps and areas for improvement and propose CAPA ⢠Support study startup and provide local expertise ⢠Perform feasibility, site identification, selection, and evaluation ⢠Provide protocol and related study training to assigned sites ⢠Conduct pre-study, initiation, routine monitoring, closeout, and co-monitoring visits as required ⢠Complete monitoring visit reports in accordance with ICH-GCP, BeiGene standards, and SOPs ⢠Manage sites and site performance by tracking regulatory submissions, recruitment, CRF completion, and data query resolution ⢠Establish regular communication with sites and report site progress, issues, and proposed actions to Clinical Operations ⢠Ensure inspection readiness of the study and sites ⢠Collaborate with the Regional Clinical Operations Manager and clinical study sites to deliver study milestones ⢠Attend disease indication project-specific training and general CRA training as required ⢠Facilitate Study Oversight Visits, site audits, and/or inspections as required ⢠Evaluate site practices and escalate quality and/or GCP issues appropriately ⢠Anticipate and identify site issues; propose corrective and preventative actions; identify gaps and promote innovation
⢠Sciences degree ⢠Master in Monitoring and Management of Clinical Trials ⢠Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook ⢠Willingness and ability to travel ⢠SSU experience is considered a plus
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