Project Data Manager

🕒 September 16

🇺🇸 United States – Remote

💵 $123.2k - $163.2k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

📊 Data Scientist

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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 studies within a program • Oversee data managers and CRO/FSP resources working on assigned studies • Serve as an active member of Clinical Study Teams • Collaborate cross-functionally to develop timelines and ensure clinical data management deadlines are met • Define external data transfer specifications and work with external vendors • Review and reconcile laboratory data with lab normal ranges • Develop or oversee development of eCRF and edit check specifications • Work with database builders on EDC databases, edit checks and reports • Drive and perform User Acceptance Testing activities for clinical trial database builds and modifications • Develop or oversee study-specific eCRF Completion Guidelines and Data Management Plans • Create and maintain data management documentation • Ensure data cleaning activities comply with Data Validation Specifications and Data Management Plans • Coordinate with coding groups on clinical study coding • Define listings for data management, clinical and medical review • Identify and troubleshoot operational problems using metrics, audit reports and project team input • Drive data review activities and escalate potential data issues to LDM • Train personnel on eCRFs and EDC as needed • Coordinate with Pharmacovigilance on serious adverse event reconciliation • Review and provide feedback on protocols, Statistical Analysis Plans, CSRs and other documents • Support process improvement and development and maintenance of SOPs and work instructions • Collaborate with program leads and other functions to ensure high-quality, on-time data delivery • Mentor junior Clinical Data Managers as needed • Perform other duties as assigned

🎯 Requirements

• 6+ years of experience in clinical data management in the pharmaceutical/biotechnology industry • Oncology experience preferred • Ability to work in cross-functional team-oriented environments • Understanding of ICH and regulatory environment as it pertains to data management • Experience with SDTM/CDASH • Strong project management skills • Excellent written, verbal and organizational skills • Must be detail-oriented • Proficient computer skills, including Microsoft Office applications • Working knowledge of at least one EDC system; Medidata Rave preferred • Ability to travel domestically and internationally as required • 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 • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness benefits • Reasonable accommodation for individuals protected by applicable laws