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IT Platform Manager - Operational Clinical Development - (AZ0686)

Местоположение Гейтерсберг, Мэриленд, США Идентификатор вакансии R-088242 Дата публикации 08/06/2020

Job Description:

AstraZeneca is making significant investments in our IT Platform Capabilities to lead business demand around IT solutions and deliver value faster adopting Agile DevOps delivery model specifically tailored towards individual platform requirements for Operational Clinical Development Value Stream.

As part of this capability built we are looking for the individual to lead the Operational Clinical Development Value stream and its associated Platform teams creating a delivery organization focused on delivering unified clinical trial platform supporting the trial set-up, initiate, execute, conduct and closer phase of any clinical trial in digitalized and adoptive approach!

This role will ensure that common architecture and technology landscape decisions support both business and IT capability strategy, and thus the platform enabled solution deliverables are aligned with relevant AZ architecture and software engineering standards, blueprints and roadmaps. The role will assess and review the work of Platform lead and their respective teams and create a balance between the immediate and the strategic priorities based on the overall IT strategic blueprint and Platform roadmap strategies!

Our vision is to deliver the best R&D IT capabilities for Clinical Development, which we define as agile, responsive and fit-for-future. Our goal is to engage with our stakeholders as a strategic partner in delivering life-changing medicines to our patients. The desired effect of this role is to take accountability as a leader for delivering a ‘Best in Class’ IT experience for the Clinical Operations and Data management organization both in TA specific and Development Operations Stakeholders and Users.

Role Overview:

What you´ll do

  • As a Platform Manager for Operational Clinical Development Value Stream you will be responsible to own the platform strategies and related roadmaps in close collaboration with respective IT Platform Lead, Product Managers and associated Capability team consisting of Business Relationship Managers, Capability Leads, Domain Solution and Information Architecture.
  • The Operational Clinical Development Value Stream IT Platform Manager will have the opportunity to collaborate with Platform Leads, Senior Platform Engineers, DevOps Leads, Release Engineers, and Solution/Integration Architects within AZ to establish standard methodologies for software development and engineering, business analysis, solution designs, enterprise software integration and project management delivery practice adopted for the platform ways for working in Agile DevOps Delivery Model.
  • Work in partnership with the Business Product Directors/Managers you will lead and oversight the value stream enabled cross platform initiatives and work closely with Platform Lead(s) and BRM to achieve your goals. The Platform consist of a wide range of product 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 Platform Leads, Release Managers, DevOps Leads, 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.
  • Supplies 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 platforms 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 empower an agile and team with varied strengths of authorities in a sophisticated matrix organization. This role is a mix of leading a team and establishing a relationship of trust with our partners, anchored by good technical and domain expertise and continuous learning and development.
  • Building strong strategic relationships with sophisticated 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.
  • Partnering with key stakeholders such as Product Directors, Capability leads and BRMs on the proactive development of detailed Platform Roadmap working with Platform Lead.
  • Presenting and gaining agreement from senior leaders for IT initiatives, demonstrating domain knowledge to gain credibility, trust, and commitment.
  • Responsible for technical supplier/vendor assessment and review of SoW and Purchase Orders on behalf of Delivery and Capability leadership team.
  • 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.

Major Role Key Activities

  • Analyzing: Assess and document platform composition and condition, identify partners 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, LRP Planning including relevant performance measures, addressing current issues and challenges, future plans 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 managers across IT. Collect feedback for improvement, ensure alignment and coordination, and avoid duplication or conflicting demands.
  • Operating: Execute on the platform roadmap, actively lead the platform as a set of interconnected assets and lead cross-platform dependencies. Present financial show back and planning associated with platform roadmaps in collaboration with IT Capability, BRMs.
  • 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 Operations and Data Management.
  • Executive Communication. Must communicate and present at the executive level: proficiency in partner buy in, strong multi-functional communication, organizational navigation, establishing 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.

Essential Skills/Experience:

This role requires cross IT technical expertise/knowledge and familiarity in all 3 core areas of Operational Clinical Development Value Stream consists of IT Product Platforms for Clinical Trial Operations, Clinical Data Management (EDC) and Biometrics Operations.

Technical/Management Expertise:

  • Consistent track record to collaborate with teams to help them understand the product’s key capabilities and benefits; understand their needs to enhance adoption of IT Solutions.
  • Worked with customers and leaders to help in validating technical concepts, vision, and roadmaps.
  • Experience working with the team to specify technical requirements for current and future products.
  • Maintained program objectives, success measurements or key performance indicators (KPIs).
  • Participated in release planning, demonstrations, and retrospectives with development teams.
  • Previous experience in Agile Methodology for backlog tracking, burndown metrics, velocity, and task definition.
  • Familiarity with common SaFe Agile practices, service-oriented environments, and better development practice.
  • Mastery of sophisticated facilitation and dependency management techniques (cross team, cross department).
  • Led cross team, ART and departmental impediments, planning, collaboration, and coordination.
  • Driven delivery and continuous improvement by utilizing feedback and metrics (quality, delivery rate, etc.) to identify areas of opportunity.
  • Experience working in IT GxP Validated environment adhering to good practices for – CSV (21 CFR Part 11, Annex 11 EU GMP, GAMP 5).
  • Consistent track record of working experience across different technology stack ranging for COTs, SaaS vs On-prem, LAMP vs WAMP, SQL vs NoSQL, Multi-tier architecture Solutions.
  • Experience working or knowledge related to TOGAF architecture and Ajax Web Development Framework.

2.Biometrics:

  • Proven understanding of clinical research with emphasis on statistical programming such as SAS. Experience with SAS Grid and Entimo Suite of Applications.
  • knowledge of ICH, FDA, and GCP regulations and guidelines; strong well-rounded technical skills, SAS, SDTM/ADaM and CDISC and Data Exchange Standards.
  • Proven success owning the statistical IT strategy to design, build and deploy enterprise level Biometrics Solution as SAS Grid or Entimo Clinical Data Analysis Suite.
  • Experience providing technical leadership for Clinical Data management Systems such as CTMS EDC), statistical environment (SAS/R/Pinnacle 21), and clinical pharmacology modeling environment (NONMEM, PsN, R, Phoenix).
  • Experience with High Performance Computing Environment based on Opensource/LAMP Tech stack including cluster filesystem and HA/ Resilient solution design, Cloud enabled infrastructure Solutions.

3.Clinical Operations

  • Direct experience with clinical operational tasks, clinical operation applications, and/or GCP compliance as it pertains to clinical trial conduct.
  • Ability to hold significant conversations with heads of clinical operations and IT regarding the eClinical applications and their use within clinical operational execution.
  • Understanding of global drug development, clinical trial process and ICH/GCP guidelines
  • Experience in, or deep understanding of, Clinical Operations functions within pharmaceutical, biotech, medical device and CRO organizations.
  • Direct experience with systems such as Veeva Vault, Oracle Siebel and goBalto, BioClinica CTMS, Medidata Rave CTMS/Strategic Monitoring, PAREXEL IMPACT, Bio-Optronics Clinical Conductor, PhlexEview, Trial Interactive, Complion, Florence eBinders, Forte Oncore and eReg, Veeva Vault, NextDocs, Documentum, SharePoint, and other clinical technologies.
  • Lead life sciences customers in the rapid configuration and implementation of applications to support clinical trial and content management (Vault CTMS, Vault eTMF, Vault Study Startup, Vault Investigator Portal).

4.Clinical Data Management

  • Direct experience with systems such as Medidata RAVE, Oracle/Phase Forward InForm, Medidata Balance, Oracle IRT, IVRS, coding applications, eSource, and other clinical technologies.
  • Familiarity with CDISC, ODM and other data management industry standards. Enterprise experience and knowledge transfer for running clinical trials with EDC.
  • Defined Data collection/extraction strategy and alignment with clinical protocol / industry data standards. Including oversight of CRO-led implementation, execution and delivery of clinical data.
  • Contributed to Strategic planning, resourcing, oversight of data deliverables including design and implementation of data capture tools, data processing, coding, validation, data quality.
  • Experience with sophisticated study designs with data coming from multiple data sources from external vendors.
  • Contributed to the design of data flow across EDC and non-EDC data sources across vendor network to ensure accuracy, completeness and compliance (including CDISC)
  • Accountable for defining the requirements for collection forms for new study protocols to ensure protocol required data for study are collected on eCRF. Worked with EDC vendor to resolve any issues.
  • Experience validating the prototype EDC and review eCRF flow dynamics and edit check specifications created by EDC vendor.
  • Reviewed and approved data transfer plan for any external data that are imported into EDC (e.g. central lab and biomarker data).
  • Run and lead the design and implementation of CDM processes with vendors, including supervising vendors responsible for creating EDC systems and transferring external data into EDC.
  • Supervised the development of study specific database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
  • Assisted in reconciling AE/SAE data in Safety DB and/or other Data Management DB, including but not limited to, performing MedDRA and/or WHO coding.

Education Requirements:

Bachelor’s/Master’s degree in Life Sciences, Computer Engineering, Electrical Engineering, Computer Science, Information Technology, or equivalent experience of 10-12 years in IT technical role related to R&D, Clinical Operations and Data Management is preferred.



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 authorisation and employment eligibility verification requirements.

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