Manager, Data Management Program Lead – Hematology

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🔥 9 minutes ago

🇺🇸 United States – Remote

💵 $123.2k - $163.2k / year

⏰ Full Time

🟠 Senior

📊 Data Scientist

👻 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

• Lead multiple clinical studies and/or programs from the Data Management perspective • Lead process development and process improvement activities to ensure quality, compliance, consistency, and operational efficiency • Influence Clinical Study Teams with Data Management expertise to mitigate study risks • Oversee technical performance of data managers and ensure timelines and data quality requirements are met • Participate in Clinical Development taskforces and initiatives focused on standardization and technology • Collaborate with other Data Management Program Leads to ensure consistency in data handling and team management • Liaise with CROs, central laboratories, and other third-party vendors on timelines and data-related deliverables • Work with database builders to develop EDC databases, edit checks, and reports • Review and query clinical trial data according to Data Validation Specifications and Integrated Data Review Plans • Review and provide feedback on protocols, Statistical Analysis Plans, CSRs, and other documents • Lead products or programs within Data Management as needed • Support Data Management standards, process improvement initiatives, and process documentation • Develop and deliver training on SOPs, processes, and standards • Drive inspection readiness, quality compliance, and training initiatives • Serve as a Data Management point of contact for study team members and vendor partners • Oversee day-to-day activities of data managers • Serve as an active member of Clinical Study Teams • Manage timelines and Data Management deadlines with cross-functional functions • Create and maintain study-specific Data Management documentation • Identify and troubleshoot operational problems, issues, obstacles, and barriers • Ensure consistency within the Data Management practice while working with other Data Management Program Leads • Perform other duties as assigned

🎯 Requirements

• 8+ years of experience in clinical data management in the pharmaceutical/biotechnology industry • Excellent experience working in cross-functional team-oriented environments • Strong oncology experience required • Strong project management skills • 5+ years of experience as Lead Data Manager • Experience developing Data Management standards • Good understanding of ICH and regulatory environment as it pertains to data management • Ability to influence others in decision-making processes with Clinical Study Teams and cross-functional teams • Microsoft Applications (Outlook, Word, Excel, PowerPoint, Project) • Working knowledge of more than three EDC systems • Medidata Rave required • SAS Viewer • Competencies in visualization tools • Ability to travel domestically and internationally • Bachelor’s degree or equivalent in a health-related field preferred

🏖️ Benefits

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