Study Start-Up Specialist

🔥 29 minutes ago

🇨🇦 Canada – Remote

💵 $69.1k - $86.4k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

👻 Ghost score 1%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 42 days.

Apply Now

Find Similar Remote Jobs

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

• Support delivery of study start-up, initial and ongoing submissions within established timelines and quality standards • Contribute to feasibility discussions during site selection • Drive kick-off and completion of tasks from site selection through activation, including timeline input for site activations • Leverage site partnership data to execute start-up efficiently and reduce cycle times • Manage and negotiate documents to achieve submission targets from start-up through close-out • Prepare and submit documents to central IRB for timely reviews • Support 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 improvement of SSU infrastructure in North America • Perform additional tasks as assigned to achieve project, functional, departmental, or corporate goals

🎯 Requirements

• Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs • Bachelor’s degree or higher degree in a scientific or healthcare discipline preferred • Minimum of 2 years of progressive experience in clinical research and clinical operations • Experience preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment • Skilled in driving kick-off and completion of site start-up tasks from selection through activation • Skilled in document management, negotiation, document preparation, and submission to central IRB • Ability to support collection and review of essential documents • Ability to complete SSU data entry in CTMS • Ability to complete timely and quality eTMF filing • Understanding of ICH/GCP and local regulations

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume