Senior Study Start-Up Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $83.8k - $113.8k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 1%

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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

• Deliver study start-up, initial and ongoing submissions within established timelines and with high quality, in accordance with ICH/GCP, BeOne’s SOPs, and local regulations • Contribute to feasibility discussions during site selection • Drive kick-off and completion of site start-up tasks from selection through activation • Provide timeline input for site activations • Leverage and build upon existing site partnership data to execute start-up efficiently and reduce cycle times • Manage and negotiate documents and leverage site relationships 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

• 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 • Familiarity with ICH/GCP, relevant country regulations/guidelines, and SOPs • Skilled in driving kick-off and completion of site start-up tasks from selection through activation • Skilled in document management and negotiation • Skilled in document preparation and submission to central IRB • Ability to ensure collection and review of essential documents • Ability to complete SSU data entry in CTMS • Ability to complete timely and quality eTMF filing

🏖️ Benefits

• Annual bonus plan for non-commercial roles • Incentive compensation plan for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness