Site Quality Risk Management Associate
Warszawa Site Quality Risk Management Associate
Warszawa
NR REF.: 1110564
About us
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.
The role
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.
Main responsibilities:
Essential Requirements
Aby uzyskać więcej informacji lub zobaczyć inne oferty tej firmy, odwiedź naszą specjalną stronę internetową https://www.hays.pl/featured-employers/astrazeneca-1874875
Warszawa
NR REF.: 1110564
About us
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.
The role
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.
Main 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
- Works predominantly independently occasionally engaging SQRM Specialist, SQRM Enabling Team Manager and SMM Lead for technical and process expertise and study related questions
Essential Requirements
- 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
Aby uzyskać więcej informacji lub zobaczyć inne oferty tej firmy, odwiedź naszą specjalną stronę internetową https://www.hays.pl/featured-employers/astrazeneca-1874875
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
