This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. As a TMF Speciality you will be required to become familiar with Trial Master File documentation and document management activities in support of client services contracts and internal ICON business needs in accordance with client requirements and ICON procedures, as applicable.
Job Title – Clinical Validation Analyst II
Reference – 043687
Location – India-Chennai
- Performs test script execution and completes validation documentation for simple edit checks.
- Reviews listing output and completes validation documentation for simple listings
Graduate or Post graduate in life science.
Note: life science with Clinical research course completion would be an added advantage
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- US/LATAM/CAN: No prior experience in software testing required.
- EU/APAC: No prior experience in software testing required.
- Successfully manage multiple tasks and timelines.
- Liaise professionally with team members and system users.
- Perform assigned tasks with moderate supervision.
- Team player with strong verbal and written communication skills.
- Demonstrated ability to learn new technologies, applications and techniques.
- Understanding of the software development life cycle.
- Understanding of database concepts.
- Recognize, exemplify and adhere to ICON’s values which center around our commitment to People, Clients and Performance.
- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
- Travel (approximately 0%) domestic and/or international.
*Performs validation/testing activities according to relevant ICON/Sponsor SOP’s and appropriate regulations.
*Reviews Data Validation Specification (DVS) document created by study team.
*Tests the clinical study database, as per procedure.
*Executes formal test scripts and reports test results accurately in a timely manner.
*Reviews Listing Validation Specification document created by study team.
*Validates listing outputs as per the study/sponsor requirements.
*Maintains and completes study documentation in a timely manner following ICON or Sponsor procedures, as applicable.
- Communicates with test lead and/or team regarding system testing progress and issues.
- Works closely with other supporting departments to ensure all testing issues are resolved in a timely manner and study timelines are met.
- Completes assigned tasks within budget and timeline constraints and reports any quality issues to lead or manager in a timely manner.
- Attends sponsor audits and assists with in-progress audits, as needed.
Participates in and contributes to internal user group meetings to share knowledge and provides latest update/features. Participates in Data Management department initiatives.
Benefits of Working in ICON
Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package.We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.
If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.