Site Quality Risk Management Specialist
Miejsce pracy: Warszawa (mazowieckie, Polska)
Nr ref.: 1110560
Forma zatrudnienia: pełen etat
AstraZeneca is one of the world’s most exciting bio-pharmaceutical companies. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that improve patients’ lives and benefit society. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world.
SQRM Specialist is a member of Site Quality Risk Management (SQRM) Enabling Team and is responsible for set up and maintenance of SQRM dashboards used by SQRM Enabling Team and local study teams to conduct SQRM.
SQRM Specialist collaborates with CM IT Specialist and CM System Owner to maintain SQRM dashboards in a validated state and trains end users on their use. Person in this role may substitute SQRM Associates in their core activities (i.e. SDX configuration in EDC system in accordance to site risk levels) if needed.
SQRM Specialist will also be responsible for SQRM tools improvement projects.
This role is located within Clinical Operations in Global Medicines Development (GMD) and reports to SQRM Enabling Team Manager.
- Sets up and maintains SQRM dashboards used by SQRM Enabling Team and local study teams to conduct SQRM, e.g. maps dashboards to study data sources, establishes and maintains connections to data sources, coordinates migrations between different environments of the systems, manages accesses and technical incidents
- Collaborates with CM IT Specialist and CM System Owner to maintain SQRM dashboards in a validated state (in accordance to the most current validation requirements)
- Trains end users on SQRM dashboards
- May substitute SQRM Associates in their core activities (SDX configuration in EDC system in accordance to site risk levels) if needed
- Is responsible for SQRM tools improvement project
- Enables business continuity and development for: SQRM processes, systems/tools, procedural documentation and training materials
- Provides support to user communities including facilitating knowledge sharing and establishing of best practice
- Works in compliance with ICH-GCP, AZ SOPs and other dedicated procedural documents
- Bachelor’s degree or higher (degree in informatics / computer sciences is an advantage)
- Basic programming skills (SQL)
- Good knowledge of spoken and written English
- Attention to details and strong focus on delivery with high quality
- Proven organizational and analytical skills
- Good communication skills
- Exhibit of AZ Values and Behaviours
- Cultural Awareness: Is aware of and sensitive to cultural differences and their impact on communication, expectations and performance
- Previous experience of working with BI tools (e.g. Spotfire, QlikView, Power BI, Tableau)
- Experience of designing and building web applications
- Knowledge of programming in R will be treated as an advantage
- Understanding of Clinical Operations technology, Data Management, Monitoring practices and regulations is an advantage
We offer stable employment conditions, wide benefit package and the opportunity to participate in building a new team.
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