Product Owner
Job Summary
Job Description
This role requires a Product Owner with over 15 years of experience in the clinical domain and at least 5 years in SAS programming for SDTM, ADM, TLF generation, and submission package preparation. The candidate must have a comprehensive understanding of the end-to-end clinical process from drug discovery to regulatory approval. Experience as a Business Analyst or Product Manager in Clinical Systems development is essential, with a preference for those with experience in Statistical Computing environments. Responsibilities include solution design, conducting demos, collaborating with stakeholders, and writing requirement specifications using the latest SDLC processes and tools. The role also involves guiding BAs, testers, and developers, providing test data, performing user acceptance testing, and demonstrating team and people management skills. Flexibility in a global work environment and awareness of clinical/life sciences industry innovations, including the application of Gen AI, are highly valued.
Must have:
- 15+ years in clinical domain
- 5+ years in SAS programming (SDTM, ADM, TLF)
- End-to-end clinical domain understanding
- Experience as BA/PM in Clinical Systems
- Solution design and demo skills
- Stakeholder collaboration
- Requirement specification writing
- SDLC process knowledge
- Team guidance and test data support
- User acceptance testing
- Team player and people management skills
- Global work environment flexibility
Good to have:
- Experience in Statistical Computing environments
- Understanding of Gen AI in clinical use cases
4 skills required
Job Details
15+ years of experience in the field of clinical domain and must have at least 5+ years of experience in the field of SAS programing in generating SDTM, ADM, TLF and complete submission package preparation.
Must have a solid understanding of end to end clinical domain from Drug discovery to Regulatory approval process.
Must have worked as an Business Analyst or Product Manager on Clinical Systems development. Having experience in Statistical Computing environments will be of great advantage.
Proficiency in solution design within the clinical business, conduct demos to internal and external stakeholders.
Very good in collaboration with Customers and internal technical stake holders.
Ability to ideate and write requirement specifications and thorough hands on with the latest SDLC process and tools used in the application development.
Must have a solid understanding of end to end clinical domain from Drug discovery to Regulatory approval process.
Must have worked as an Business Analyst or Product Manager on Clinical Systems development. Having experience in Statistical Computing environments will be of great advantage.
Proficiency in solution design within the clinical business, conduct demos to internal and external stakeholders.
Very good in collaboration with Customers and internal technical stake holders.
Ability to ideate and write requirement specifications and thorough hands on with the latest SDLC process and tools used in the application development.
Ability to manage and guide the BAs, Testers and developers in all the functional aspects and provide Test data support.
Ability to perform user acceptance testing as per the business use cases and report the issues.
An excellent team player and people management skills to manage the teams as needed.
Must be flexible working in the global work environments.
Must be abreast of latest news and innovations in the Clinical / Life Sciences industry
Understanding of application of Gen AI on clinical use cases, problem solving ability using Gen AI will be of great advantage
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