Orion Innovation is a premier, award-winning, global business and technology services firm. Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity. We work with a wide range of clients across many industries including financial services, professional services, telecommunications and media, consumer products, automotive, industrial automation, professional sports and entertainment, life sciences, ecommerce, and education.
With our constant expansion and growth, we are currently looking for a new candidate to join our team in our office in Serbia as a contractor, working fully remotely as a Process Analyst/Business Analyst
Our client is one of world's largest pharmaceutical companies, working in human pharmaceuticals, and biopharmaceuticals dedicated to bringing greater treatments to patients.
Essential Job Responsibilities:
- Work with business teams to define gaps, facilitate discussions to develop migration specifications.
- Own alignment of business requirement changes with IT and business stakeholders.
- Liaise among business and IT stakeholders to define future state business processes and user
requirements.
- Create and update appropriate documentation following SDLC standards and templates
- Participate in requirement sessions
- Make any updates to the process narratives and requirements based on these sessions
- Provides input towards validating and testing, and updating project documentation
- Validate that the solution design meets business and functional requirements
- Review test plans and testing results while maintaining traceability of end user requirements
- Assist end-users in preparation and execution of User Acceptance testing
- Domain Knowledge: Understands Pharmaceutical or Life Sciences domain, Regulatory and how
technology solutions can improve or enhance existing processes and overall business results.
- Business Requirements Analysis/Documentation: Facilitating workshops and interviews, defining,
documenting, and communicating business processes and requirements.
- Requirements Testability and Traceability: Verifying that requirements used in test cases match
those requirements used in the development process
- Veeva experience highly preferred.
Required skills:
- 4-5+ years’ experience with clinical data management system implementation or related support
- Client side experience or experience supporting/driving a CDMS/EDC implementation
- Experience with Vault CDMS, Medidata RAVE
- Understanding of the E2E clinical data management processes for Study Build and Study Conduct, CDMS Integrations, CDMS analytics and reporting
- Experience drafting user requirements, validation strategy and test cases for CDMS initial implementations
- Experience conducting gap analysis on client procedural documents and drafting training materials, procedural documents, etc for end users based on CDMS process defined
- Establish and maintain relationships with stakeholders
- Manage deliverables across multiple workstreams
- Strong business process modeler skills with experience in as-is/to-be business process analysis and
- Strong BA skills able to develop BRD and the ability to quickly learn and understand the
system and process based on current requirements.
- Very strong written and oral communication skills
- Skills-Self-starter, Understanding of Regulatory business processes…
What we offer:
- Dynamic and supporting international teams.
- Fully remote work
- Flexible day schedule
- Equipment for work, laptop and all necessary additions.
- The service agreement contract
- Access to trainings and courses
Orion is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, citizenship status, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
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