Job Title：Software Validation Engineer

Department：Software Validation

Essential Function：

• Devise and design test strategies, test plans,
• And test scripts to support project validation efforts.
• Operate with moderate direction,
• Interfacing Development, Product and Project Management,
• Quality and other project team members.

Key Accountabilities：

• Develop and executes detailed test specifications. Records and tracks detailed results.
• Maintain test scenarios and test data for projects under test.
• Work closely with project team members throughout the entire software development life cycle.
• Participate in requirements and functional specification reviews, documentation reviews, and project walk-troughs.
• Participate in software defect review meetings. Monitor and maintains software defect tracking database.
• Review all pertinent project documentation.
• Assist in the creation / maintenance of Standard Operating Procedures.
• Respond to all inquiries regarding the project under test.
• Track issues in defect tracking system. Prepares defect metrics reports. Analyzes defect metrics for trends and progress.
• Reports on project testing to management.

Job Title ：Associate Software Validation Engineer

Department：Software Validation：

• Essential Function：
• Operate with direction, interfacing with Product and Project Managers,
• Development, and Quality,
• Application Development and Project Management and other project team members.
  
  

Key Accountabilities：

• Execute detailed test specifications. Records and tracks detailed results.
• Work closely with project team leaders throughout the entire software development life cycle.
• Review all pertinent project documentation.
• Respond to all inquiries regarding the project under test.
• Track issues in defect tracking system.
• Reports on Project testing status to Project team leaders.
• Clinical Research Associate (临床监察员)

1.To perform clinical monitoring activities of designated projects in accordance with the APEX SOPs.
2. Accountable for detecting, analyzing and solving technical, procedural and/or motivational problems that may affect the progress of the project.

Pre-Study Stage
1.Participate in the identification and selection of potential investigators to ensure that the sites have adequate time and can fulfill their obligations to the study.

2.Assist or support those involved in regulatory and ethics committee/IRB submissions and in the generation of Financial Agreements according to standard and local country practices. Ensure that documents are collected in a timely manner to meet regulatory and ethics committee/IRB submission dates.

Study Initiation Stage
3.Initiate investigational sites to ensure that they have a thorough understanding of the clinical protocol and the requirements of the study, and that they can fulfill their obligations to conduct the study accurately.

4.Ensure the effective and timely co-ordination of the supply of clinical materials to the site.

In-Study Stage
5.Perform site visits to ensure that the site personnel are conducting the study in accordance with the protocol and ensure that any issues arising from the visit are documented in a visit report and addressed with the site timely. Escalate Concerns or ongoing issues to the direct supervisor and the Project Manager.

6.Provide ongoing training to the site personnel to ensure the quality and integrity of the data.

7.Ensure that the principal investigator complies with the serious adverse event reporting requirements as defined by both the client and regulatory authorities.

Administrative Tasks
8.Prepare and submit visit reports and complete routine administrative tasks in a timely manner.

9.Perform ongoing on site data management/collection to ensure that any issues are communicated to the site personnel timely. Maintain close contact with Data Management.

10.Maintain project tracking system on an ongoing basis to ensure that progress regarding the sites can be tracked and reported to the Project Manager as required.

11.Assist with the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures.

12.Attend staff meetings and training sessions as required to complete the Training Modules in a timely manner.

Study Files
13.Interact with investigators to obtain necessary documentation and information before, during and after the study. Ensure accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete and can be used as a source of reference.