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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Statistics / Analytics |
| EmploymentType | Full-time |
The Associate System Set-up Analyst (aSSA) supports the SSA in the implementation of the eClinical platform and ensures quality delivery. For assigned trials, the aSSA creates User Acceptance Test scripts, prepares testing environment, executes tests or QC. The aSSA sets-up trial technologies if appropriate.This role requires understanding the detailed needs of the study, the technical capabilities of technology. The aSSA will keep current on the latest developments and technology options through training and mentorship opportunities provided by System Set-up Analyst.Key Accountabilities Support User Acceptance Test to validate system configuration on study level Create Test scripts, prepare testing environment, execute UAT and QC Support system set-up configuration Stay updated on technology and clinical trial process developments and requirements within ParexelSkills Communicationo Excellent verbal and written communication skills.o Strong customer focus (internal and external) Coordinating global virtual teams around trial technology set-upo Proven ability to manage independently competing priorities with attention to detail Technical and data standard experienceo Experience in clinical trial systems (e.g, CTMS, EDC, IRT)o Develop detailed awareness of Parexel and external vendor software and tools with practical knowledge of how these applications worko Demonstrated adeptness in learning new systems and function in an evolving technical environment Business processo In depth understanding and experience of clinical trial processeso Knowledge of SOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application. Generalo Commitment to quality and quality management.o Commitment to operational efficiencyo Flexibility to change.QualificationsEducation Education in life sciences and/or computer sciences and / or equivalent experience.Language Skills Excellent English written and oral communication skills.Minimum Work Experience Substantial experience in the Clinical Trial business, understanding the process steps and contributors involved Experience of configuring technology for Clinical Trials (Systems Development Experience not required) Experience in requirements documentation IRT or Digital Health Experience is a plus,
Keyskills :
clinical trials21 cfrvirtual teamstest scriptsuser acceptanceinternational regulationswritten communicationsystem configurationlife sciencescustomer focusoral communicationlife cycleclinical trial