Manager, Data Management Program Lead, Hematology

Accountabilities

• Lead data management activities across multiple clinical studies and/or programs, ensuring high-quality deliverables, appropriate timelines, and effective risk mitigation.
• Provide technical and functional guidance to data managers and oversee day-to-day activities to ensure study milestones and data timepoints are completed successfully.
• Serve as a key data management point of contact for clinical study teams, cross-functional stakeholders, CROs, central laboratories, and other external partners.
• Collaborate with database builders on EDC database development, edit checks, reports, and other study-specific data management requirements.
• Review and query clinical trial data in accordance with data validation specifications and integrated data review plans, as appropriate.
• Review and provide input on protocols, Statistical Analysis Plans, Clinical Study Reports, and other clinical development documentation.
• Partner with other Data Management Program Leads to promote consistency, standardization, and effective data handling practices across programs.
• Support the development, maintenance, and implementation of data management standards, processes, SOPs, work instructions, and related documentation.
• Identify opportunities for process improvement, technology adoption, and greater operational efficiency within Data Management.
• Develop and deliver training on data management processes, standards, and procedures to internal, outsourced, and cross-functional teams.
• Support inspection readiness, quality compliance, and training initiatives related to Data Management.
• Troubleshoot operational issues, risks, obstacles, and barriers affecting studies, programs, or strategic initiatives.
• Contribute to Clinical Development taskforces and initiatives focused on standardization, technology, and continuous improvement.
• Ensure data management deadlines are aligned with broader clinical development timelines and program objectives.
• Lead or oversee multiple studies and programs while maintaining consistency and quality across the Data Management practice.
• Perform other duties and responsibilities as assigned.

Requirements

• Bachelor’s degree or equivalent, preferably in a health-related field.
• 8+ years of experience in clinical data management within the pharmaceutical or biotechnology industry.
• Strong oncology experience, with hematology experience highly relevant to the role.
• At least 5 years of experience working as a Lead Data Manager or in a comparable clinical data management leadership capacity.
• Demonstrated experience working effectively in cross-functional, team-oriented environments.
• Strong project management capabilities, including the ability to manage multiple studies, programs, timelines, and stakeholders simultaneously.
• Experience developing and implementing Data Management standards, processes, and best practices.
• Solid understanding of ICH guidelines and the regulatory environment applicable to clinical data management.
• Ability to influence cross-functional stakeholders and contribute confidently to decision-making and risk mitigation discussions.
• Experience with multiple EDC platforms; working knowledge of more than three EDC systems is preferred, with Medidata Rave required/preferred.
• Proficiency with Microsoft applications, including Outlook, Word, Excel, PowerPoint, and Project.
• Working knowledge of SAS Viewer and competencies with data visualization tools.
• Strong analytical and data interpretation skills, with a detail-oriented and quality-focused approach.
• Excellent communication, collaboration, problem-solving, and stakeholder management skills.
• Demonstrated initiative, adaptability, continuous learning, and a results-oriented mindset.
• Willingness and ability to travel domestically and internationally when required by business needs.

Benefits

• Annual base salary: $123,200–$163,200, with actual compensation determined by factors such as experience, skills, education, certifications, and work location.
• Eligibility for an annual bonus plan for non-commercial roles.
• Opportunity to receive discretionary equity awards and participate voluntarily in an Employee Stock Purchase Plan.
• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan.
• FSA/HSA options.
• Life insurance coverage.
• Paid time off and wellness benefits.
• Remote work opportunity within the United States.
• Opportunities to contribute to innovative clinical development programs and improve data management practices at scale.
• Collaborative, cross-functional environment with exposure to global clinical development activities.