Clinical Data Manager
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Update day: 26-03-2024
Category: Administrative / Clerical / Assistant IT - Hardware / Networking Information Technology Arts / Design Executive management Serving / Cleaner / Maids PG / PB / Reception
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Job content
Your responsibilities will include:
Design and develop eCRFs and eCRF completion guidelines and/or user guidance
Configure the EDC system to the requirements of a specific trial
Perform / oversee user acceptance testing, user training, database release activities
Program edit checks and data queries
Program status/metric reports
Develop Data Management (DM) related documentation (e.g. DM plan, Data base (DB) validation plan, DB release forms…)
Develop and implement data transfer agreements with third parties
Provide support to end users
Review DM Standard Operating Procedures
Ensure study timelines are met and data quality conforms to high industry standards
Lock, transfer and archive databases.
Profile required:
Master’s degree in computer science, physics, mathematics or equivalent in experience
At least two years of clinical database development experience
Experience using Electronic Data Capture (EDC) system(s)
Experience working with Oracle and clinical database application
Knowledge of SQL, PL-SQL - SAS and CDISC is a plus
Fluency in English (oral and written)
Understanding of the clinical research environment and good knowledge of global regulatory requirements such as ICH GCP and CFR 21 part 11
An analytical mindset with problem-solving skills
Detail-oriented with excellent organizational and communication skills
Deadline: 10-05-2024
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