Manager, Data Management Program Lead, Hematology
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, Data Management Program Lead, Hematology based in the United States.
This is an impactful individual contributor role supporting clinical development programs from a data management perspective.
You will lead and oversee data management activities across multiple clinical studies and programs, with a strong focus on hematology and oncology.
The role combines strategic oversight, technical expertise, cross-functional collaboration, and operational leadership.
You will help ensure clinical data is delivered on time, at high quality, and in compliance with applicable standards and regulations.
The position also offers opportunities to shape data management processes, standards, technology adoption, and operational improvements.
You will work closely with clinical study teams, data managers, vendors, CROs, laboratories, and other functional partners.
This is an environment suited to an experienced data management professional who enjoys influencing decisions and driving excellence across complex programs.
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.
- 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.
- 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.
Requirements
Benefits
Skills
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