Vacancy expired!
Job Req #: 21-12538Job Description: Application Support/Safety Support AnalystLocation: RemoteJob Type: Contract Key Responsibilities:
- Defines project requirements for Argus system release activities by identifying key deliverables, phases and acceptance criteria, to guide stakeholders and vendors to configure, validation and implement.
- Performs detailed data requirements gathering and analysis to provide high quality and detailed requirements, ensuring the closest involvement and agreement from the user community. Responsible for overall requirements matching to business solution expectations/ needs.
- Consults with multiple stakeholders (e.g. the business owner /business lead / System owner) to construct the system requirements
- Be a go to Subject Matter Expert (SME) for end-to-end Argus functionalities, database, queries, report generation and requirements.
- Create other SLC documents as needed, work with compliance and quality team to get them reviewed and route for approvals
- Create, update and maintain a Change Requests, BRS, Configuration Spec, Requirements Traceability Matrix, IT System Admin SOP, OQs and PQs
- Responsible for the management of the safety data-related activities but not limited to, generating reports, listings from the Argus database, database queries, coordinating Argus user access and database changes
- Participation in Argus release implementation, validation of system changes
- Responsible for providing operational support, triaging the Argus support tickets, assign and follow-up with vendor to bring the tickets/requests to closure
- Support MedDRA and WHODD upgrade activities
- This role is remote based anywhere in the US.
- Must have experience performing business configurations in Argus Safety database
- Must have prior experience with executing System testing(OQ) and User Acceptance Testing(PQ) scripts
- Prior experience with computerized systems validation, GxP and SLC process and documentation
- Prior experience working with external vendors
- Must have experience with SQL and relational databases.
- Must be proficient in Microsoft Excel, Word, and PowerPoint
- Must have strong analytical and problem-solving skills, with the associated curiosity to enable solving complex problems with little assistance.
- Must be self-motivated, detail oriented and able to multi-task.
- Must possess excellent communication (oral and written) skill regarding both medical and technical topics.
- Must have strong interpersonal/organizational skills.
- Must maintain superior end user support at all times with all users.
- Must possess the ability to work in a team environment and follow written policies/procedures.
- Experience working with business partners and CROs is a plus
Vacancy expired!