Data IT Product Lead - Clinical Standards

AstraZeneca UK

Location: Cheshire East, Gaithersburg, Maryland

Job Type: Full time


Data IT Product Lead - Clinical Standards

Role Overview:

As a Clinical Data IT Product lead, you will be key member of the Clinical Standards Product IT DevOps team which will be core product feeding into downstream products such as EDC, Clinical Data Review & Monitoring landscape to ensure data is capture, transform, and publish in adherence to CDISC standards (CDASH, SDTM, ADaM, TFL Automation) in conformed and harmonized way.

The IT Product lead will have the opportunity to collaborate with Platform Manager, Product Manager/Owner, Senior Platform Engineers, DevOps Leads, Release Engineers, and Solution/Integration Architects within AZ to establish best practices for software development and engineering, business analysis, solution designs, enterprise software integration and project management within BizDevOps IT Platform Delivery Model.

Work in partnership with the IT Platform Manager, Business Product Director/Manager you will lead and oversight the value stream enabled cross product/platform initiatives and work closely with Platform Manager/other IT product leads and stakeholders to achieve your goals. The Platform consist of a wide range of product and technology components where we are harmonizing both backend and frontend solutions into a service catalogue of solutions enabled within Platform framework.

Assesses business and technical requirements and business priorities as well as leads high-level investigations or analysis aligned to the strategy.

Leads, Coaches and Mentors a team of Lead Engineer, Release Manager, DevOps Lead, Senior technical Platform Engineers and Release Engineers while applying business acumen to deliver high-valued results.

Influence the designs for sophisticated technical solutions in a balanced and manageable way using existing and new platforms, in close collaboration with enterprise and solution architecture and software engineering practice.

Contributes as a technology advisor identifying technical implications and providing strategic and technical recommendations to support business objectives in line with overall Platform Strategy.

Accountable for implementing strategies covering testing, release, and documentation for applicable IT Product working through respective Platform lead and DevOps Platform team.

This role requires a hybrid set of technical, business domain, and leadership skills. You are encouraged to perform as a leader-doer with the ability to encourage and motivate an agile and diverse team of authorities in a complex matrix organization. This role is a mix of leading a team and building a relationship of trust with our partners, anchored by good technical and domain expertise and continuous learning and development.

Building strong strategic relationships with complex customer groups and senior stakeholders, developing a deep understanding of the short-term and long-term business direction & IT strategy.

Facilitating accurate IT Platform demand forecasting, planning, and delivery collaboratively with respective Platform Teams under scope of the Operational Clinical Development Value Stream.

Leading technical impact assessments, identifying risks and issues that may affect current and future solutions within the Platform framework.

Presenting and gaining buy-in from senior leaders for IT initiatives, leveraging domain knowledge to gain credibility, trust, and commitment.

Perform the hands-on Technology Lead role across multiple initiatives, taking on IT Ownership for identified platforms/systems and collaborating closely with various business departments, other IT resources and our vendors both to develop, maintain and support the IT Platform E2E through offshore delivery centers.

Accountable for delivery of current-state system improvements and future-state requirements driving innovation and seeking new technical solutions contributing to the Applications portfolio realignment and thereby consolidating the existing applications into targeted platform framework.

Role Related Key Activities:

  • Analyzing: Assess and document platform composition and condition, identify stakeholders and expectations on run (i.e., operations), exploit (e.g., requests) and new and current projects and issues.
  • Defining: Define and develop the platform strategic, roadmap, Long term Planning including relevant performance measures, addressing current issues and challenges, future for changes and opportunities for improvement.
  • Engaging: Proactively socialize the platform roadmap with business functions using the platform and with other platform, process, and partnership across IT. Collect feedback for improvement, ensure alignment and coordination, and avoid redundancy or conflicting demands.
  • Operating: Execute on the platform roadmap, actively manage the platform as a set of interconnected assets and manage cross-platform dependencies. Present financial show back and planning associated with platform roadmaps in collaboration with IT Capability, Business Partners.
  • Evaluating: Assess the health and operational performance of the platform against established metrics. Achieve and improve operational service metrics and/or targets associated with platforms.
  • Problem Solver/Critical Thinker: This role requires someone who can understand the issues, the broader context, and help to develop strategic and specific solutions.
  • Technology Savvy: This role will be benefitted by an individual who is a quick learner and able to utilize different software technologies.
  • Process Implementation & Improvement Experience: The ideal candidate will have experience creating, implementing, and improving global processes, particularly within Clinical Data Management.
  • Executive Communication. Must communicate and present at the executive level: proficiency in stakeholder buy in, strong cross functional communication, organizational navigation, building rapport across functions and levels of management.
  • Improving: Identify and realize opportunities to increase the value of the platform by extending cost-effective use and/or reducing platform costs through rationalization, consolidation, streamlining, and price negotiation.

Key Responsibilities:

What You'll Do

  • Lead and Participate in the development and maintenance of IT Platform responsible for global clinical data standards, including operational (CRF and non-CRF) CDISC Study Data Tabulation Model (SDTM), controlled terminology, non-CRF standard data mappings (e.g., lab or ECG), and other applicable industry standards. This could include automated creation of the metadata and mappings between the standards (operational and SDTM, TLFs), and documentation of the use of the standard.
  • Participate in IT solutioning to provide inputs for standards components, such as CRF design, CRF Completion Guidelines, programmed edit checks, Data transfer specifications, SDTM mapping specifications and SDTM annotated CRF per Standards Product Roadmap.
  • Act as SME on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology.
  • Act as a consulting resource for project teams regarding the validation of SDTM domains, which may include output from industry standard software tools and BMS custom validation programs.
  • Work with standards management systems and software, such as Metadata Repository, Change Request systems, SDTM validation systems, and issues tracking systems, in the development of systems and processes for creation and maintenance of data standards, including specifications, mappings between standards, and checking adherence to these data standards.
  • Ensure Technical support to Study Standards Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files).
  • To Collaborate with external vendors and CROs to support EDC integrations with third party platform (ePRO, IRT etc.)
  • Working with engineers and enterprise domain and technical architects to design and build scalable Clinical Standards and data platform components and frameworks.
  • Co-own the roadmap, working with Clinical Standards product manager/owners to enable features per release planning in Platform Operating Model.
  • Ensure successful product adoption by evangelizing and supporting the use of the Platform.
  • Manage software implementation projects and customers during the lifecycle of an implementation focusing on project planning, gap analyses, workshop delivery, requirements gathering, configuration, validation, migration, integration, training, and go-live activities.
  • Guide our customers through successful implementations from inception through adoption, ensuring alignment of processes to system design and functionality. Think critically about business requirements to ensure the solution reflects business requirements and focuses on customer success and adoption.
  • Serve as the primary customer liaison managing communication, risks, and project reporting between the project team, customer, and internal stakeholders.
  • Mentor DevOps team members consultants in the platform team to provide technical leadership for Platform team.
  • Collaborate cross-functionally with Platform governance and Community of Practice at all level and with other teams across the company around strategic enterprise initiatives.
  • Design easy to use, scalable, and highly performant features to ensure customer success from beginning to end of the engagement life cycle.
  • Provide release management, technical cutover, environment management and infrastructure automation services.
  • Provide technical expertise to execute and manage deployment activities for each sprint.
  • Manage risks and resolve issues that affect release scope, schedule, and quality.
  • Collaborate with key Development and Quality Assurance stakeholders in developing and executing a robust test and release process.
  • Facilitate resolution of deployment problems with Development, Quality Assurance and Technical Operations.
  • Proactively identify, recommend, and implement software release process improvements to maximize efficiency adopting CI/CD framework and toolkits both in functional and integration components of the platform.
  • Provide technical oversight on configuration, customization, UX Configuration for product releases and projects.
  • Provide technical expertise on integration technologies to release and project scrum teams working on the development, implementation, maintenance and improvement of Integration designs and solutions.
  • Generate and implement ideas to simplify / streamline our integration landscape in alignment with integration design and patterns.
  • Responsible to ensure that technical specification and design documents are updated as changes are configured within the Platform landscape.

Essential Skills/Experience Required:

Clinical Data Technology Domain:

  • Bachelor’s or master’s degree in relevant field such as Health Sciences, Life Sciences, Data Management, Information Technology or Biostatistics or equivalent experience.
  • Minimum 5 years working experience in clinical data management, clinical data conversion or clinical data programming. Submission experience is a plus.
  • Accredited Certifications from SCDM/ACDM or any vendor offered data management trainings.
  • End to end knowledge of clinical trial development processes and its associated system landscape.
  • Strong experience in implementing Industry Standards (e.g., SDTM CDISC) in either the collection (CDASH) or tabulation (SDTM).
  • Knowledge or experience with standard terminology systems such as MedDRA, SNOMED, ICD-9/10, LOINC, NCI-EVS, CDISC terminology, HL7/FHIR, etc.
  • Strong understanding of FDA/ICH guidelines for clinical study data
  • Should be able to work effectively as a member of multi-functional teams across programming, biostatistics, data management and clinical sciences.
  • EDC build (Rave)/Inform and global library maintenance support experience a plus
  • Previous experience with a COTS MDR system from Entimo, Formedix, Sycamore technology clinical vendors.
  • Knowledge of relational databases and experience using multiple clinical data management systems.
  • Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
  • Working knowledge of CDASH, SDTM, SEND or ADaM, and CDISC controlled Terminology.
  • Working knowledge of clinical trial terminology and Architect Loader Specification.
  • Expertise in specialized analysis and reporting standards development skills (e.g., clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) or expertise in Biometrics functions (e.g., Programming, or Statistics)
  • Experience with external vendors and CROs to support Standards or EDC integrations with third party platform (Central Lab, ePRO, IRT, Data Review/Monitoring, etc.)

IT Engineering:

  • Expertise and engineering mindset to help design and implement a Clinical Data Solutions adhering to Products on Platform Strategy.
  • Proven ability to manage diverse stakeholders and ensure delivery to a high degree of satisfaction.
  • Proven ability to work independently in a dynamic, fast-moving environment.
  • Confidently communicate and interpersonal skills to lead customers, from technical personnel to senior stakeholders, in urgent or critical situations.
  • Knowledge of Identity management solution based on OKTA, Oauth, Ping Federate/AD technologies.
  • Experience in development of Interfaces/Integration between on-premises and SaaS Platform enabled Products using API’s, Web Services (MuleSoft) and ETL (SnapLogic) tech enablers.
  • Some Knowledge of using/creating build tools and CI/CD (maven, ant, gradle, Sonar or similar tools).
  • Experience with Cloud Platforms such as AWS, AZURE.
  • Experience working with JIRA, Confluence, Bitbucket, Automated Testing tools.
  • Experience of working in agile teams using methodologies such as SCRUM and SAFe.
  • Experience programming in Java or other object-oriented programming languages.
  • Experience delivering or developing workshop material, training, gap analyses, or requirements gathering sessions with business and system stakeholders.
  • Proven track record leading high-impact system implementations and the ability to collaborate and manage diverse stakeholders in clinical standards and data management functions and ensure delivery to a high degree of satisfaction.
  • Ability to act with speed to understand requirements, create corresponding solutions, and willingness to “roll up your sleeves” to design and implement the clinical data standards landscape including downstream interfaces to Data Capture, Automated data conformance validation and ingestion.

Why join us

Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Make the impossible possible by building partnerships and ecosystems, creating new ways of working and driving scale and speed to deliver exponential growth. Focused and committed, and backed with the investment to succeed, we’re driving cross-company change to disrupt the entire industry.


Are you up for an exciting challenge and ready for making a difference? If so, hit Apply today - we can't wait to hear from you!

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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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