Senior Study Start-Up Specialist

🔥 16 hours ago

🇨🇦 Canada – Remote

💵 $76k - $95k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 1%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations • Contribute to discussions during the feasibility stage of site selection • Drive kick-off and completion of tasks from selection through activation, including providing timeline input for site activations • Leverage and build upon existing site partnership data to execute start-up efficiently and reduce cycle times • Manage document preparation, negotiation, and submission to achieve submission targets from start-up through close-out • Prepare and submit documents to central IRB to ensure timely reviews • Ensure collection and review of essential documents • Complete SSU data entry in CTMS • Complete timely and quality eTMF filing • Support development of local workflows to streamline output and deliverables • Contribute to ongoing improvement of SSU infrastructure in North America • Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals

🎯 Requirements

• Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs • Bachelor’s degree or higher in a scientific or healthcare discipline preferred • Minimum of 3 years of progressive experience in clinical research and clinical operations, preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment