Medical Sciences Opportunities at PAREXEL
Project SpecialistJob ID 52033BR Hyderabad, Telangana, India
Provide Study Archival and CD burning support during the study closures in SIS.
Upload the project related reports in PMED.
Develop, validate, install, implement, and train on all technical aspects within Safety Services.
Ensure safety database setup and administration, application and users support, training, documentation, validation and user acceptance per individual client project.
Work closely with Safety Services staff or vendor support to ensure proper analysis, resolution and closure of issues.
Coordinate software updates, change requests and application support for the safety database.
Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance,
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with
attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork.
• Excellent problem-solving skills.
Knowledge and Experience:
• Relevant experience in the PS/ or similar role desired.
• Specific experience in one or more of the following areas: ORACLE SQL or PL/SQL, VB and any other I.T. discipline that would be of value for safety databases.
• Understanding of the Clinical Research and development process including post-marketing approval, in
particular with respect to patient safety and regulatory reporting requirements.
• University/College degree with strong technology background.
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