Director, Data Management Reporting

Company: Daiichi Sankyo, Inc.
Location: Basking Ridge
Posted on: April 8, 2025

Job Description:

Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.Job Summary:The Director of Data Management (DM) Reporting provides leadership in Data Management Operations for the Data Validation and Reporting function by collaborating with internal and external stakeholders to oversee the development and delivery of clinical data programming, reporting, data visualizations, external data acquisition and validation, and tools to support project portfolio across drug programs. This role is responsible for ensuring the quality and timely delivery of programming deliverables, including integrated data review plan (IDRP), study data listings and exception reports, sample data reconciliation, external data acquisition, validation, and reconciliation, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements that adhere to programming standards and specifications across clinical studies. This position involves managing direct reports and/or leading multidisciplinary teams, as well as overseeing functional service providers to achieve business objectives. It requires extensive knowledge of clinical data programming, external data handling, techniques, standards, methodologies, and skills in working with internal and external systems, CROs, and vendors. Excellent verbal/written communication, analytical, organizational, and interpersonal skills are essential for effective collaboration with individuals at different levels and from diverse disciplines and cultures. Line management experience, the ability to manage and coach people, and the capability to lead multiple projects concurrently are crucial for this role. Advanced knowledge of Data Management, Biostatistics, Clinical Operations, Pharmacovigilance, handling and processing of raw data and external data, CDASH/SDTM, industry best practices, and relevant regulatory requirements is essential. This position demands significant skills in working in fast-paced environment, continuous improvement, project management, change management, and risk management.Responsibilities:Leadership, Direction, and Strategy:Is accountable for the management and oversight of all DM programming, reporting, and external data acquisition and validation deliverables for all studies consistent with IDRP, study data listings, exception data listings, sample reconciliation, external data acceptance and reconciliation reports, study data protection, operational metrics, and clinical trial quality and risk management reporting requirements. Oversees the execution of external data - acceptance, storage, and delivery activities to ensure complete, high-quality data is available for use by clinical study teams in a timely manner. Provides oversight for external data validation and quality control process for verification of the data structures in line with data transfer agreements. Manage and oversee the DM programming staff and Functional Service Provider subject matter experts at the functional level to support project portfolio milestones, and/or initiatives to achieve/exceed departmental quality/time/cost objectives.Leads development and implementation of DM reporting strategy and solutions at the program level to achieve/exceed quality, time, and cost objectives embracing agile programming methodologies, novel approaches, and industry best practices. Drives execution of the DM programming, reporting, and data visualization activities across all studies to ensure on-time delivery of accurate and high-quality programming deliverables.Champions and facilitates change management through providing rationales, describing improved outcomes and increased efficiencies to achieve programming operational excellence. Provides strategic input, develops tactical approaches, and proposals to advance DM Data Validation and Reporting initiatives. Leads or participates in departmental and/or multidisciplinary teams working on continuous process improvements and other initiatives. Proactively identifies and manages risks to data quality, data integrity, programming and reporting deliverables, and timelines. Collaborates with various Governance/Steering Committees, Functional Line Management, and multidisciplinary teams to develop, implement, and promote efficient programming methodologies and techniques, optimizing programs and outputs for quality, efficiency, and positively influencing daily operations.Functions as the DM Operations Data Validation and Reporting escalation point for all programming, reporting and external data validation deliverables across all studies; proactively develops solutions within and across functions and resolves complex issues and conflicts in a timely manner. Identifies Data Validation and Reporting staffing needs, prepares annual resource projections, monitors staff utilization, participates in assessment and hiring of candidates. Performs line management duties (provides feedback, conducts formal reviews, confirms training completion, and drives career development) for direct reports, and mentors DM Operations Data Validation and Reporting staff. Directs programming representation in audits and regulatory inspections to provide relevant programming and reporting information as needed. Provides input for DM questions in health authority information requests. Builds and maintains positive business relationships with other line functions, vendors, and partners; is an ambassador and advocate for the data operations programming function with key internal and external stakeholders. Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings. Represents Daiichi Sankyo DM at professional conferences/meetings.Project Management:Is accountable for the completion of DM programming, reporting, external data acquisition, processing, and validation activities for drug programs under the outsourcing and in-house operating models. Is accountable for the quality, integrity, and timely delivery of all external data in line with the established data transfer agreements. Is accountable for oversight for DM Data Validation and Reporting resources, CROs, and vendors to ensure compliance with the programming standards and practices, SOPs, external/internal data standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines. Accountable for inspection readiness of DM programming documentation filed/archived according to applicable Daiichi Sankyo and regulatory requirements.Communicates with Data Operations leadership, asset leads, DM staff, and cross-functional team leads regarding goals, expectations, timelines, overall status, risks, data trends, and issues. Proactively responds to the needs of the asset leads, DM staff, and cross-functional teams and influences appropriately to ensure successful delivery of the programming deliverables aligned to business priorities. Leads prioritization and planning with the teams to ensure outcomes meet expectations.Functional Expertise:Assesses vendor Scope of Work for Data Validation and Reporting needs; engages in vendor meetings; reviews and evaluates RFPs; contributes to the proposals for contracted programming external data services; manages vendor relationships by coordinating at the governance level. Instills incorporation of industry DM programming best practices, reporting technologies, and discipline to achieve operational excellence. Accountable for adherence to DM programming standards, methodologies, data standards, and reporting technologies ensuring quality delivery of DM programming and reporting services. Provides guidance and expertise on programming of complex data listings and reports, usage of tools and technologies, data extraction mechanisms, data visualizations, and automation to advance the maturation of programming, reporting, and external data validation capabilities. Expertise in code optimization, frameworks/libraries, testing strategies, ETL/ELT capabilities, optimizing data flows, data normalization, reporting processes; data and programming standards; emerging data capabilities and methods. Implements quality-by-design approaches to confirm the quality, integrity, and fit-for-use of the external data based on appropriate and/or established data-cut-off as a pre-requisite for database lock.Operational Efficiency / Continuous Improvement:Provides leadership for operational efficiencies and productivity gains through improved programming standards, code optimization and reuse, data capabilities and methods, and automation. Challenges the status quo, encourages innovation, takes suitable risks to drive improved outcomes through agile programming methodologies, novel approaches, and technology aimed at improving quality and efficiencies. Evaluates repetitive tasks, programming errors, testing strategies, and expedites the delivery of high-quality outputs through automation. Establishes key performance indicators and continuously monitors them to detect trends and pinpoint areas for enhancements. Leads or participates in cross-functional process improvement initiatives. Maintains awareness of and disseminates information about emerging trends, best practices, data standards, clinical programming methods, techniques, and technology recommendations to enhance business capabilities, improve compliance and achieve operational efficiencies. Develops and maintains networks with thought leaders in DM and related areas.Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.Education:Bachelor's degree in life sciences or related field requiredMaster's degree in life sciences or related field preferredExperience:11 or more years of experience with Bachelors (or 9 with Master's degree). Experience includes database and data validation programming and/or related work experience in a medical device, biotech, or pharmaceutical company, or similar environment (e.g., CRO); knowledge of industry standard clinical technologies, data standards, raw data handling and processing, external data acquisition, validation, reconciliation, and data visualizations/analytics experience required5 + years managing people required5+ managing initiatives requiredDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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