Resultados de la búsqueda: 5 vacantes
...action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient...
...Ensures user acceptance test is not a defect discovery exercise.
• Ensures all test deliverables and artifacts adhere to QA SOP and WI.
Qualifications
What we’re looking for
• Bachelor’s degree or equivalent
• Experience testing GxP applications...
....
Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
Triages ICSRs, evaluates... ...are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the...
.... May serve as a voting statistician on DSMBs and/or DMCs.
• Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation...
...• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records... ...are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
Responsible for one or more of the following...
