Company Profile:

At AstraZeneca's Oncology Business Unit, we’re all here to make an impact – to achieve our bold ambition of eliminating cancer as a cause of death. We relentlessly follow the science, challenging the status quo to deliver more effective treatments to patients in need. Our dedication means we purposefully push back the limits of knowledge to change the practice of medicine. To ensure no patient is left behind, no matter what stage of disease. We’re brave disruptors – entrepreneurial, adventurous and pioneering in our approach. Here you have the opportunity to step up, take personal accountability and lead changes in our ever-evolving environment.

Job description:

Job Title - Senior Consultant - Platform Engi

Career Level - D2

 

Leverage technology to impact patients and ultimately save lives

Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!

 

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.

 

ABOUT OUR IT TEAM

It’s a dynamic and results-oriented environment to work in – but that’s why we like it. There are countless opportunities to learn and grow, whether that’s exploring new technologies in hackathons, or redefining the roles and work of colleagues, forever. Shape your own path, with support all the way. Diverse minds that work cross- functionally and broadly together.

 

About the role

AstraZeneca is currently looking for IT Functional 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:

The role of our ideal candidate will include but not limited to

• Build, Test, Deploy and release the fix by following the standard SDLC and ITIL process using Agile methodology.

• Should be able to work on application enhancements, application upgrades when vital. Should be open to work on exciting tasks/requirements when needed.

• Take ownership of the assigned L2/L3 level tickets/tasks and drive it to closure.

• Fix application issues by referring the application logs and by a dry run of the application code. Should be able to spot and provide a fix through application code changes if vital.

• 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.

• Should be able to liaise with other internal teams/vendors (third-party suppliers) as applicable for addressing an application issue and in case of any project need.

• 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

• 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 stakeholders and project team members are geographically dispersed.

 

Educational Requirements

• Bachelor or master’s degree in computer science or life science related discipline with IT/CRO/Pharma experience with total of 7+ years of experience