Senior Manager, Data Management Program Lead, Hematology

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

📋 Description

• Oversee multiple clinical studies and/or programs from a Data Management perspective.

• Lead the development of processes and improvement initiatives to ensure quality, compliance, consistency, and operational efficiency.

• Utilize data management expertise to influence Clinical Study Teams in mitigating study risks.

• Supervise the technical performance of data managers, timelines, and ensure high-quality data finalization.

• Engage in Clinical Development taskforces along with standardization and technology initiatives.

• Collaborate with other Data Management program leaders to maintain consistency in data handling and team management.

• Coordinate with CROs, central laboratories, and other third-party vendors regarding timelines and data deliverables.

• Collaborate with database developers to create EDC databases, edit checks, and reports.

• Examine and query clinical trial data in accordance with validation specifications and integrated data review plans.

• Assess and provide insights on protocols, Statistical Analysis Plans, Clinical Study Reports, and other documentation.

• Manage local products or programs within Data Management as necessary.

• Promote Data Management standards, process enhancement initiatives, and documentation processes.

• Develop and conduct training on SOPs, processes, and standards.

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

• Act as the Data Management point of contact for study team members and vendor partners.

• Oversee the daily activities of data managers.

• Participate actively in Clinical Study Teams.

• Manage timelines and Data Management deadlines in collaboration with other functions.

• Create and maintain study-specific Data Management documentation.

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

• Ensure consistency within the Data Management practice while collaborating 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/biotechnology sector.

• Proven experience working in cross-functional, team-oriented settings.

• Strong expertise in oncology is essential.

• Excellent 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 concerning data management.

• Ability to influence decision-making within Clinical Study Teams and cross-functional groups.

• Proficient in Microsoft Applications: Outlook, Word, Excel, PowerPoint, Project.

• Working knowledge of more than three EDC systems.

• Experience with Medidata Rave is mandatory.

• Competencies in SAS Viewer.

• Skills in visualization tools.

• Willingness to travel domestically and internationally.

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

🏝️ Benefits

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

• Eligibility for an incentive compensation plan for commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• Flexible Spending Account/Health Savings Account.

• Life Insurance.

• Paid Time Off.

• Wellness programs.