Dev Ops Associate Engineer for Saama
hace 1 semana
AstraZeneca is currently looking for IT DevOps Engineer to join our R&D IT Solution Delivery Team to manage and maintain our SaaMa product, that is GxP compliant, part of Clinical Development Platforms and is used across late science teams across all therapeutic areas. You will be a part of our BizDevOps team therefore will be responsible to work cross functionally with other team members such as Product Lead, DevOps Lead and technical engineers.
**Key Responsibilities**:
- Build, Test, Deploy and release the fix by following the standard SDLC and ITIL process using Agile methodology.
- Take ownership of the assigned L2/L3 level tickets/tasks and drive it to closure.
- Provide resolution for the user reported issues within the defined timelines (as per the internal SLA/OLA standards).
- Proactive monitoring of the ticketing queues and other support channels to quickly acknowledge and respond the user reported issues. Should be able to meet the defined response SLA.
- Understand and debug the python programming code.
- Able to design and deploy reports via MicroStrategy and crystal reports.
- Send detailed and timely communication to users in case of planned/unplanned outage. Should be able to lead an outage call and drive it to resolution.
- Follow good documentation practices such as creating KBAs (Knowledge Base Articles) and publishing it for quicker and easier access to better address the issues/tickets.
- Create backlogs/Story/Epic in JIRA (as appropriate) and work on it based on the business priority.
- Should be good at Collaborator engagement.
- Constantly thrive to learn and upskill according to the organization’s goals and demands.
**Mandatory Skills**
- 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 7 years working experience in clinical standard and data collection, 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.
- Experience working in implementing IT Solutions Industry Standards (e.g., SDTM CDISC) in either the collection (CDASH) or tabulation (SDTM).
- Working knowledge of CDASH, SDTM, ADaM, and CDISC controlled Terminology 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
- Understanding of Rave EDC terminologies and eCRF data variables, matrices, Rave database and Rave report modules
- Experience in data reporting and analytics programming using **Visual Studio Cystal Report and MicroStrategy.**:
- Knowledge in SQL and/or python programming
- Knowledge of relational databases and experience using multiple clinical data management systems.
- Working knowledge of clinical trial terminology and Architect Loader Specification.
- Assisted in specialized analysis and reporting standards development activities (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.)
- Experience of change management process in GxP validated SaaS environment.
- Excellent written, verbal communication and relationship management skills
- Able to work independently with minimum supervision
- Knowledge of Agile/Scrum methodology
- Experience working with JIRA, Confluence, BitBucket
- Expertise and engineering mindset to help design and implement a Clinical Data Solutions adhering to Products on Platform delivery model
- 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.
- Some Knowledge of using/creating build tools and CI/CD (MAVEN, ANT, Sonar or similar tools).
- Experience with Cloud Platforms such as AWS, AZURE
- 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
**Preferred Skills**
- EDC build (Rave)/Inform and global library maintenance support experience a plus
- Previous experience with SaaMa/any clinical vendor is a plus
- Self-motivation and an ability to contribute to rapidly evolving programs
- Worked in a global organization where stakeho
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