SQRM Associate is a member of Site Quality Risk Management Enabling Team and is responsible for translation of source data verification and review strategy defined in study documents into settings of EDC system (RAVE). SQRM Associate is also responsible for adjustments of these settings in accordance to the actual site risk level assigned by local study team. All SQRM Associate activities will be commenced after EDC is declared live. 

SQRM Associate will be involved in SQRM tools maintenance and improvement projects.

SQRM Associate will engage SQRM Specialist and SQRM Enabling Team Manager when needed.

This role is located within Clinical Operations in Global Medicines Development (GMD) and reports to SQRM Enabling Team Manager.

Typical Accountabilities | Job Responsibilities

• Sets up and updates SDX (SDV/SDR) configuration in EDC system (after it is declared live) to reflect site risk levels assessed by local study team
• Performs quality checks and documents modifications to SDX configuration related to SQRM process
• May be involved in SQRM tools maintenance and improvement project
• Supports business continuity 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 predominantly independently occasionally engaging SQRM Specialist, SQRM Enabling Team Manager and SMM Lead for technical and process expertise and study related questions
• Work in compliance with ICH-GCP, AZ SOPs and other dedicated procedural documents

Education, Qualifications, Skills and Experience

• Bachelor’s degree or higher
• Solid computer skills (e.g. MS Office)
• Attention to details and strong focus on delivery with high quality
• Good knowledge of spoken and written English
• Exhibit of AZ Values and Behaviours
• Cultural Awareness: Is aware of and sensitive to cultural differences and their impact on communication, expectations and performance
• Understanding of Clinical Operations technology, Data Management, Monitoring practices and regulations is an advantage

Date Posted

Closing Date

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.