Manager, Clinical Data Standards

2 weeks ago

Basking Ridge NJ United States Daiichi Sankyo, Inc. Full time

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.

Summary

The Manager, Clinical Data Standards is responsible for the development and sustainability of the Global Clinical Data Standards for quality submissions and success of the Daiichi Sankyo R&D pipeline by managing activities associated with standards development, management, and implementations for DS Therapeutic areas. This position provides expertise within Data Management by partnering with diverse cross functional stakeholders to optimize data collection services for Daiichi Sankyo Programs. The position will also help in defining standards collection and mapping data definitions thereby ensuring alignment with industry (CDISC) standards for Health Authority regulations. Working knowledge of various data types, data collection methods (EDC & Non-EDC), and direct experience implementing industry standards (e.g., Controlled Terminologies, CDISC CDASH, SDTM, ADaM, etc.) for data submissions and relative processes is a must. Demonstrated ability to self-start, be solution-oriented with an innovative spirit, and be accountable for results by working in a fast-paced environment are some of the requirements of this role. Leading-edge skills in clinical data standards, expertise in Study Data Tabulation Model (SDTM), excellent verbal/written skills, analytical, and interpersonal skills for working effectively with people at different levels are also some of the requirements of this role. The Manager, Clinical Data Standards should be a subject matter expert in clinical data standards as it relates to developing clinical data collection tools.

Responsibilities

  • Leadership, Direction, and Strategy: Leads implementation of Program / Therapeutic level clinical data collection requirements by partnering will Internal (BDM, Non-BDM Functions) and External stakeholders (Central Labs, Vendors, Specialty Labs, etc.) to drive consistency of data acquisition, processing, and reporting of diverse external data across DS Programs. The individual may be responsible for leading and coordinating preliminary data processes related to new Indication areas, which may require creation of standards from scratch rather than updating or changing existing standards.
Serve as the subject matter expert from Data Standards standpoint, collaborate with Head of Data Standards, Standards Governance Committee and Data Governance bodies to ensure DS Data Standards are aligned with regulatory requirements and the organizational policies and procedures. Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings, and builds and maintains positive relationships with internal/external stakeholders/vendors/partners.

  • Project Management: Provides guidance and technical knowledge for collection of new and existing data standards for assigned DS Program / Studies by employing subject matter expertise. Ensures modern core data sources (ex : Biomarker Data, Medical Devices Data, etc.) are effectively developed in compliance with CDISC / SDTM industry standards for diverse DS Programs operating under the outsourced and in-house operating models. Help in developing and tracking Therapeutic Area specific Data Standards metrics including identify standards gaps, data standards awareness, standards adoption and developing trends. Responsible for the development and maintenance Daiichi Sankyo’s Clinical Data Standards as well as the procedural documents and charters relating to global data standards and governance processes for continuous improvement opportunities. Complies with the protocol, Policies, SOPs, external/internal standards, pertinent Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines.

  • Functional Expertise: Process clinical data change requests for new or existing metadata, propose standards driven changes complying to CDISC SDTM as applicable, and ensure that the request is processed through the appropriate levels of the Standards framework.
Participate in review of Protocols, Global Clinical Libraries, Standards package, etc. to enhance efficiencies and forward-looking in standardizing eCRFs, data checks, reports/listings, etc. Lead, facilitate and participate in the committees of the Clinical Data Standards, partner with functional area stewards, organize standards topics to be reviewed and ensuring decisions are made in a timely manner. Act as a consulting resource for Study Data Managers, project teams regarding the collection of new and existing clinical data. Reinforce data content and interpretations of Daiichi data standards to project teams to ensure consistency in understanding and implementation across Programs. Participate in data standards team meetings and provide input for standards components such as CRF Design, CRF Completion Guidelines, Programmed Edit Checks, Data Transfer Specifications, SDTM mapping and annotated eCRFs. Accountable for the maintenance, and peer review of key Daiichi Sankyo procedural documents (SOPs/SOIs), including standards templates, guidelines, etc. to ensure data standardization across programs.

  • Operational Efficiency / Continuous Improvement:
Responsible for developing and promoting the strategy and infrastructure for creation, maintenance, and implementation of clinical data standards across all Therapeutic areas across Daiichi’s portfolio. Helps in building relationships across the Daiichi Sankyo organization for establishing the standards vision and implementation to collect robust clinical data across each therapeutic area. Ensure coherence of standards initiative cross-functionally and externally. Contributes/participates in the selection of functional technologies, (MDR, CDR, EDC) thereby developing optimal approaches to support the collection of diverse clinical data. Develop necessary training materials, sessions, and facilitate lessons learned discussions within the department. Share new industry standards, best practices within department as required. Remains current with and disseminates information about external data trends and advancements, regulatory requirements, and emerging technology innovations to optimize Daiichi Sankyo external data processes.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

  • Bachelor's degree In life sciences or related field required

Experience Qualifications

  • 4+ years clinical data management experience required

  • 5+ years in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease therapeutic area experience required

  • Working knowledge of Clinical trial data systems such as Medidata Rave (EDC), Metadata Repository (MDR) and CDR required
  • 4+ years Clinical Data Standards background, expertise in data models, formats, structures including data definitions. Knowledge of CDASH, CDISC / SDTM and industry standard data collection practices. Critical thinking and analytical skills, including attention to details required

Daiichi 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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