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Associate Director, Clinical Data Standards

3 months ago

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

Join a Legacy of Innovation 110 Years and Counting

Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.

Summary

The Associate Director, Clinical Data Standards, is responsible for the development, maintenance, and enforcement of data standards through extensive collaborations with Daiichi Sankyo's internal and external stakeholders. Proven experiences in Oncology Therapeutic area with Medical / Scientific acumen in Solid and Liquid tumors, understanding of the CDISC (SDTM, ODM.XML, CDASH) industry standards, Metadata management and Data Mappings and are some of the key requirements of this role.

This role also requires leadership for the continued development and enforcement of data standards, demonstrated knowledge of industry standards related regulatory requirements (CDISC), FDA & ICH, PMDA, EU & ICH, CRP and being influential in reaching prompt decision making to support DS Program developments. This position provides expertise within the Biostatistics and Data Management teams by having the Medical / Scientific knowledge for designing of CRFs, efficient Data Collection methods, Codelist / Dictionary Managements including Non-CRF Data Mappings (ex: External Data) for data submissions and relative processes.

Working knowledge of early and late-stage submissions per local/regulatory requirements, 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. In addition, significant experiences in the use of data management systems (EDC, MDR, CDR), knowledge of data management processes, tools, methodologies, and scientific know how for overall data collection strategy is a must for the sustainability of the Daiichi Sankyo R&D pipeline.

Responsibilities

- Leadership, Direction, and Strategy:

  • Leads implementation of Therapeutic level clinical data collection requirements including cross-functional standards initiatives by partnering with Internal (BDM, Non-BDM Functions) and External stakeholders to drive consistency of data acquisition, processing, reporting to ensure coherence of standards initiatives across organization.
  • Establishes the Data Standards Governance Framework, related processes and develops metrics for continuous improvement opportunities; responsible for driving preliminary data processes related to new Indication areas, requiring creation of standards from scratch rather than updating or changing existing standards.
  • Drive the Standards Governance Committee sessions including related Data Governance bodies to ensure DS Data Standards are aligned therapeutically with regulatory requirements.
  • Partner with functional area stewards, organize standards topics to be reviewed and ensuring decisions are made in a timely manner and ensure that data transfer processes comply with CDASH and SDTM standards, facilitating efficient data analysis and reporting.
  • Promote Daiichi Sankyo values and quality workplace culture by nurturing collaboration in cross-functional and multicultural settings including leading implementation of data standards practices within vendor relationships.

- Project Management:

  • Accountable for developing and promoting the strategy and infrastructure for the creation, maintenance, and implementation of clinical data standards across all therapeutic areas across Daiichi Sankyo’s RD pipeline.
  • Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.
  • Standardize upstream data collection methodologies for faster EDC design and build aligning with protocol data collection objectives.
  • Responsible for the development and maintenance of Daiichi Sankyo’s Clinical Data Standards libraries, Data Standards packages, Standards Charter, Reporting Inventories, Standards Templates and Guidelines, including standards GSOP for continuous improvement opportunities.
  • Communicate and reinforce content and interpretation of Daiichi Sankyo’s Clinical Data Standards to DS Project and Study teams, to ensure consistency in understanding and implementation of standards across a project.
  • 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.

- Functional Expertise:

  • Lead data standardization initiatives to ensure DS Programs and Protocols comply with Therapeutic standards, complying to CDSIC SDTM standards, any regulatory requirements as well as the established DS clinical data standards framework.
  • Define, manage, and govern clinical data standards; Global Libraries, Standards Packages, Reporting Suites, etc. to optimize standards efficiencies for clinical data collection. Support filing and submission readiness activities ensuring alignment with regulatory requirements.
  • Responsible for the creation and/or maintenance, and peer review of key Daiichi Sankyo procedural documents (SOPs/SOIs), including standards templates, guidelines, etc. to ensure data standardization across programs.
  • Contributes/participates in the selection of functional technologies, (MDR, CDR, EDC) thereby developing optimal approaches to support the collection of diverse clinical data.
  • 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.

- Operational Efficiency / Continuous Improvement:

  • Promotes value of data standards and builds network of data driven methodologies for collection of quality data complying to industry standards CDISC (SDTM).
  • Ensures coherence of standards initiative cross-functionally and externally.
  • Attend study and project team meetings (when needed) as Standards SME and provide input for standards components for designed eCRFs, programmed Edit Checks, Reporting Library, etc.
  • Develop training strategy for companywide adoption of Clinical Data Standards, initiate Data Standards Workshops, cultivate Standards driven Framework to utilize standards at all levels (CRF Non-CRF), create Data Standards newsletters, best practices, etc. for successful adoption of standards.
  • Remain abrased with and disseminate information about data collection trends, industry advancements, regulatory requirements, and emerging technology innovations to optimize Daiichi Sankyo’s clinical data standard 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

  • 7 or more years experience in a pharmaceutical, biotech company, or similar environment with extensive Clinical Data Management (CDM) and Standards experience, hands-on experiences in all aspects of data activities required
  • 7 or more years experience in Oncology trials with an understanding of the complex and interdependent relationships between protocol development, data collection, CRF designing, analysis and reporting preferred
  • 4 or more years experience with combined people and initiatives management 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.