Manager, Data Management Program Lead – Hematology

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the execution of various clinical studies and programs from a Data Management perspective.

• Drive the development and enhancement of processes to ensure quality, compliance, consistency, and operational efficiency.

• Leverage Data Management expertise to guide Clinical Study Teams in minimizing study risks.

• Supervise the technical performance of data managers, ensuring adherence to timelines and data quality standards.

• Engage in Clinical Development taskforces and initiatives aimed at standardization and technological advancements.

• Collaborate with fellow Data Management Program Leads to promote consistency in data handling and team oversight.

• Act as a liaison with CROs, central laboratories, and other external vendors regarding timelines and data-related deliverables.

• Work alongside database developers to create EDC databases, implement edit checks, and generate reports.

• Review and query clinical trial data in accordance with Data Validation Specifications and Integrated Data Review Plans.

• Provide feedback on protocols, Statistical Analysis Plans, Clinical Study Reports, and other relevant documents.

• Lead specific products or programs within the Data Management scope as necessary.

• Support Data Management standards, process enhancement initiatives, and the documentation of processes.

• Create and conduct training sessions on Standard Operating Procedures (SOPs), processes, and standards.

• Foster inspection readiness, quality compliance, and training initiatives.

• Serve as a point of contact for study team members and vendor partners in Data Management.

• Oversee the daily operations of data managers.

• Participate actively as a member of Clinical Study Teams.

• Manage timelines and Data Management deadlines in collaboration with cross-functional teams.

• Develop and maintain study-specific Data Management documentation.

• Identify and resolve operational challenges, issues, and barriers.

• Ensure uniformity within the Data Management practice while coordinating with other Data Management Program Leads.

• Perform additional duties as assigned.

⛳️ Requirements

• A minimum of 8 years of experience in clinical data management within the pharmaceutical or biotechnology industry.

• Proven experience in cross-functional team environments.

• Extensive experience in oncology is required.

• Strong project management capabilities.

• At least 5 years of experience as a Lead Data Manager.

• Experience in developing Data Management standards.

• Solid understanding of ICH guidelines and the regulatory landscape related to data management.

• Capability to influence decision-making processes within Clinical Study Teams and cross-functional teams.

• Proficiency in Microsoft Applications (Outlook, Word, Excel, PowerPoint, Project).

• Familiarity with more than three EDC systems.

• Experience with Medidata Rave is required.

• Knowledge of SAS Viewer.

• Competence in visualization tools.

• Willingness to travel domestically and internationally.

• A Bachelor’s degree or equivalent in a health-related field is preferred.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Participation in an incentive compensation plan for commercial roles.

• Access to discretionary equity awards.

• Option to voluntarily participate in the Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance.

• 401(k) retirement plan.

• Flexible Spending Account (FSA)/Health Savings Account (HSA).

• Life insurance benefits.

• Paid Time Off (PTO).

• Wellness programs.