RBQM Programmer job vacancy

AL2S3 LTD

Overview: RBQM Programmer job vacancy in Not Specified recruiting now

Ref: 1401561
Employer: AL2S3 LTD
Location: Not Specified, United Kingdom
Salary:
Employment Type: Permanent

Job Details:

*JOB DESCRIPTION*

George Higginson & AL Solutions are pleased to kick-start the summer of 2022 by offering an incredibly rare opportunity to be exclusively partnered with a global, international full-service CRO. This modern company is consistently expanding, consistently collaborating with a globally known Pharma’s and Biotech’s, and therefore, are looking for a RBQM Programmer (Risk Based Quality Management).

*RBQM+ Programmer (Risk Based Quality Management)*

The *RBQM+ Programmer *will.

* Review and understand the clinical protocol to support CDRA/RBQM+ LEAD in the identification critical data and processes, safety and data integrity risks related to protocol execution Support cross-functional study team and RBQM+ LEAD in Protocol Risk Assessment, risk identification and evaluation, and development of the Integrated Risk Management Plan, as required Perform all programming related activities in the set up and maintenance of the Risk-Based Quality Management (RBQM) system based on study team requirements, data sources and structure, in collaboration with the Clinical Data Risk Analyst (CDRA). This will include transforming data in SAS to for use by the RBQM system and developing and maintaining RBQM system dashboards and robust data analyses. Perform peer reviews of study setup in RBQM software, as required Implement the tailored Key Risk Indicators (KRIs) and Quality Tolerance Limit parameters (QTLs) specifications for each study in the RBQM system, ensuring consistency with applicable standards, in collaboration with the CDRA/RBQM+ LEAD Provide programming support to deliver timely and high-quality risk-based monitoring data analytics for the cross-functional study team; partner with the CDRA and RBQM+ LEAD to identify and resolve issues as required Support CDRA/RBQM+ LEAD during risk review sessions with cross-functional study team throughout clinical trials lifecycle Support CDRA/RBQM+ LEAD in conducting end of trial summarization of risk management activities, including QTL and other issue findings summaries, in preparation for inclusion to clinical study report. Provide support to ensure inspection readiness for clinical risk management and clinical data risk analysis scope of activities Champion programming component of RBQM within the company and participates in continuous improvement and development of risk management processes and system

*Qualifications*

* Proven experience in a pharmaceutical/biologics/biotechnology company BS/BA preferably in a scientific or technical discipline Thorough knowledge of Good Clinical Practice/ICH E6 (R2+) Guidelines and/or other applicable regulatory requirements for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management

*Skills *

* Knowledge of clinical trials and strong technical experience in using SAS including SAS Macros to report the results of clinical trials and/or integrated analysis for submission Strong critical thinking, programming and analytical skills and aptitude for data analytics including mathematical and statistical concepts Experience with data analytics and data visualization technologies Familiarity / knowledge of clinical trials risk management concepts and principles in the Pharma or CRO industry High degree of accuracy and attention to detail Experience and understanding of clinical trial data from various sources (e.g. Clinical devices, SDTM, RAVE, IRT, CTMS, etc.) Ability to work collaboratively in a team environment whilst managing changing priorities to achieve goals/targets.

* Excellent oral and written communication skills

*How To Apply*

AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies –

*George Higginson*

*AL Solutions*

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