Senior Lead R&D Solutions Architect

ZS life science R&D team partners with clients to discover and develop innovative medicines that improve patient lives. Our work spans across consulting, analytics and technology (services and platforms) projects across several domains. We have 3,500+ professionals delivering R&D programs, invested in R&D data, analytics and technology assets, and 100+ clients on R&D programs.

Clinical/Drug Development Division

We display a substantial history of contributing to numerous client projects with significant results in drug development. The Drug Development R&D Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting.

Team Expertise

Our team is well-versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. We specialize in designing bespoke solutions or product implementation for clinical design, data management, and analytics systems.

Key Technologies

• Rave
• Veeva
• InForm
• eClinical elluminate
• SAS LSAF
• Oracle LSH
• Nurocor
• Sycamore
• Formedix
• Domino
• Sas Viya systems

Role Responsibilities

1. You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics, and RBQM.
2. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader.
3. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact.
4. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time.
5. You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases.
6. Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents.
7. You will plan and facilitate various requirement gathering, solution meetings and artefacts.
8. You will work on creating process flows based on client and internal project discussions.
9. You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming.
10. Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules.
11. You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community.

Requirements

1. Bachelor degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines.
2. Masters degree in business analyst, Engineering or Science preferred.
3. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required.
4. Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required.
5. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams.
6. Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required.
7. Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred.
8. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required.
9. Experience in building and delivering GxP compliant solutions for large enterprise program is required.
10. Exposure to programming language like R, Python and SAS is preferred.

Benefits

• Significant supervisory, coaching and hands-on project management skills.
• Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects.
• Willingness to travel to other global offices as needed to work with client or other internal project teams.
• In-silico, digital twin, and/or modeling experience.

Position Details

• Industry Type: Analytics / KPO / Research
• Department: Data Science & Analytics
• Employment Type: Full Time, Permanent
• Role Category: Data Science & Machine Learning
• Education
• UG: Any Graduate
• PG: Any Postgraduate
• Key Skills
• RSAPython
• CDR SAS LSAFOracle LSHePRO
• RaveInFormeClinical elluminateVeevaLABeCOA