Astellas Pharma Data Standards Manager in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing a Data Standards Manager opportunity in Northbrook, IL.
Purpose & Scope:
The position will contribute to the development, management and maintenance of Astellas clinical trial data standards (CTDS). The position is responsible for ensuring that CTDS are developed according to established processes and procedures, maintaining agreed upon CTDS content, and helping to ensure global adoption and organizational accountability for adherence to CTDS. This position will contribute to the overall objectives of the Global Data Management Operational Support team.
- Responsible for maintenance of the CTDS within the data standards repository.
- Contributes to the process for management of CTDS, ensuring clinical study team accountability for adherence to global standards. Proactively identifies standards related issues and proposes resolution.
- Manages the existing CTDS and processes requests for new CTDS as submitted by project/study teams. Assists with the review and approval process for new and modified standards.
- Drives the process for development of CTDS content with study teams and key stakeholders.
- Participates in the CTDS development in project/study teams; develops and executes processes to ensure consistent development across teams.
- Communicates regularly with the Team Lead to assure alignment on CTDS across teams and functions.
- Responsible for standardizing the structure and content of all existing and proposed CTDS and maintaining this content consistently in the data standards repository.
- Responsible for quality assurance for standards based deliverables.
- Contributes to the development and maintenance of SOPs for CTDS processes and related tools.
- Assists with the overall training plan and develops training materials related to CTDS content, tools and the process for development, management and use of CTDS.
- Responsible for delivery of standards related training content.
- Supports efforts to integrate standardization into current processes throughout the global clinical trial process.
- Reports to the Team Lead, Data Standards and is a member of the Data Management Operational Support team.
- Contributes to the implementation of the Global Data Science (GDS) mission and objectives for implementation of the overall CTDS plan for GDS.
- Influences stakeholders across functional lines and management levels to assure support for and conformance to data standards initiatives.
Essential Job Responsibilities
Provides subject matter expertise by overseeing or acting as a technical expert with the following responsibilities:
- Awareness and understanding of data standards (CDASH, SDTM, ADaM).
- Ability to share data standards knowledge across functions and study teams.
- Participates in industry standards development organizations and shares current thinking, best practices and key decisions internally.
- Subject matter expertise of work processes and practices in one or more functional areas - data management, clinical programming or biostatistics.
- Manages content and updates to the data standards repository. Manages development of data standards.
- Understands the need to build an external network to support industry level data standardization initiatives.
- Works with any vendors providing support to Astellas data standards implementation and maintenance.
People Development Management
Helps educate members of cross-functional teams with regard to standards training and processes.
Performance and Resource Management
- Works to established timelines and key performance indicator goals. Suggests improvements as appropriate.
- Works to timelines, standards, processes and quality targets for work assigned to data standards.
- Monitors adherence to standards related processes including governance and change control. Escalates deviations from standards processes as necessary to Team Lead.
- Contributes to global process, standards harmonization and process improvement efforts.
- Monitors adherence to standards related processes including governance. Works with Astellas clinical study teams to assist with data standards selection and use of data standards.
- Maintains data standards and related processes for GDS overall.
- Works with study teams to select applicable data standards for individual studies. Works to ensure consistent application of data standards across a drug program. Assists study team members as required.
- Serves as member of the internal review teams within GDS in regards to new or improved GDS applications/software tools, with a focus on applications supporting the use of standards and automation of key business processes.
- Remains informed regarding technical solutions that support data standards.
- Participates in meetings with therapeutic area leads in support of therapeutic area data standards development.
- Records development of standards and processes for the collection and communication of human safety information.
- Ability to communicate with peers and global colleagues in the same function and other peers and management inside and outside of GDO.
- Contributes to data standards and data standards repository training materials.
- Consistently supports the use of data standards.
- Continually seeks to help others understand and use standards.
- Supports the GDS organization of approximately 100 individuals and the Astellas Pharma Global Development (APGD) organization of approximately 300 additional individuals as well as members of Medical Affairs, by offering consultation, advice, and subject matter expertise regarding data standards and supporting processes.
- Global responsibility for maintenance of approximately 25 controlled data standards quality documents (e.g., SOPs, Working Practice Documents, etc.) within the GDS organization. Acts as subject matter expert, as necessary, to develop any required updates.
- Collaborates with 20-30 study teams across Phases I-IV to develop data standards and consult on the application of data standards to specific therapeutic areas and studies.
- Supports standards training sessions 2-4 times annually to members of APGD, Medical Affairs and other stakeholder groups.
Reports to the Team Lead, Data Standards and is a member of the Data Management Operations team.
- BS or MS degree in Life Sciences, Computer Science, Informatics or related discipline. Minimum of 5 years in pharmaceutical industry or CRO, with minimum of 2-3 years experience using data standards. Combination of formal training and experience equivalent to the above may be considered.
- Industry level experience with CDISC, including understanding of CDASH, SDTM and ADaM, and related industry and health authority initiatives.
- At least 2 years experience in working on global projects or process and system initiatives.
- Understanding of clinical development and processes within data management, clinical programming, and biostatistics.
- Must be a strong and effective strategic thinker and problem solver, requiring the ability to both recognize and anticipate problems.
- Strong computer skills required, including clinical database management systems and/or SAS clinical programming experience.
- Is recognized as a key contributor and technical expert within the data science disciplines.
- Excellent verbal and written communication skills and is capable of working with individuals across multiple disciplines, projects, cultures and regions.
- Displays the highest level of personal commitment to the Astellas Code of Ethics. Inspires while holding all appropriately accountable. Commits through co-accountability to the growth and health of GDO, APGD, and Astellas
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Global Development Operations