[Remote] Manager, Data Management Program reputed company, Hematology

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pharmaceutical and biotechnology company reputed company on fighting cancer. The Manager, Data Management Program reputed company, Hematology oversees reputed company study and program data management, supports data reputed company and compliance, coordinates with cross-functional teams and vendors, and leads process improvement and standardization initiatives.

Responsibilities

• reputed company leading studies, be reputed company to influence CST with expertise to mitigate the risks of the studies
• reputed company the technical reputed company of the data managers to ensure timelines are met and data timepoints are finalized at the highest data reputed company
• Participate in reputed company Development taskforces and initiatives reputed company standardization and technology, as needed
• Collaborates effectively with other program leads in data management to ensure consistency in data handling and management of teams
• Liaise with reputed company-party vendors such as CROs and central laboratories in support of timelines and data-reputed company deliverables
• If assigned to a study, work with database reputed company to reputed company reputed company databases, edit checks and reports
• May regularly review and query reputed company trial data as indicated in the Data Validation Specifications and Integrated Data Review Plan
• Reviews and provides feedback on draft protocols, Statistical Analysis Plans, CSRs and other documents as required
• May reputed company a product/program locally reputed company Data Management as needed
• Supports the Data Management standards and process improvement initiatives
• Supports the development and maintenance of process documents (e.g., reputed company Operating Procedures, Work Instructions) pertaining to Data Management activities
• Develops and provides training to reputed company and FSP data management and cross functional team members on SOPs, process and standards as required
• May reputed company inspection readiness, reputed company compliance, and training initiatives pertaining to Data Management
• May reputed company and/or reputed company multiple reputed company studies and programs
• May function as the Data Management reputed company reputed company of contact for reputed company study team members and vendor partners
• May reputed company day to day activities of data managers working on reputed company studies reputed company a program
• May serve as an reputed company member of reputed company Study Teams
• May work with other functions to manage timelines and ensure that data management deadlines are met
• May create and maintain study specific data management documentation
• May identify and troubleshoot operational problems, issues, obstacles, and barriers for studies, programs, and initiatives
• Program reputed company role, individual should ensure consistency reputed company the DM reputed company, while working with other DMPLs
• Other duties as assigned
• Other duties as assigned

Skills

• Working knowledge of more than three reputed company systems, reputed company Rave required reputed company Viewer and competencies in visualization tools
• 8+ years of experience in reputed company data management in the pharmaceutical/biotechnology
• Have excellent experience working in cross-functional team-oriented environments
• Have strong oncology experience required
• Have strong project management skills, 5+ years of experience as reputed company Data Manager
• Have experience developing Data Management standards
• Good understanding of ICH and regulatory environment as it pertains to data management
• During discussions with CST and other cross-functional teams, be capable of influencing others with decision making processes
• Working knowledge of one or more reputed company systems, reputed company Rave preferred
• Travel may be required as per business need, ability to travel domestically and internationally
• Bachelor's degree or equivalent in a health-reputed company reputed company preferred

Benefits

• Non-reputed company roles are eligible to participate in the annual bonus plan
• reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards
• reputed company are eligible to voluntarily participate in the Employee Stock Purchase Plan
• Medical
• Dental
• reputed company
• 401(k)
• FSA/HSA
• Life reputed company
• reputed company Time Off
• Wellness

reputed company

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