Job Description
What you’ll do
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You will design & implement various innovative solutions in the realms of clinical trial, data management, analytics You will work in designing common data model based on clinical standards like SDTM / ADAM/ I ISS/ ISE . You will work on designing safety data mart for cross study analysis and exploratory analysis You will work on building analysis ready datasets which serves various safety and exploratory use cases across clinical trials. You have experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration As a solution lead, your role will involve planning, offering tech consultancy, conducting assessments,and executing technology projects. You will support leaders in engaging with clients to review clinical data models , determining requirements, establishing safety usecases, and delivering solutions that have significant impact. 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 You will review and author high-level user stories and develop related tasks, acceptance criteria and review test cases Your will work closely with project teams in creating requirement Specifications, requirement traceability metrics, user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community.
What You’ll Bring
Bachelor’s degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Master’s degree in business analyst, Engineering or Science preferred. Experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of clinical data standards like CDISC (SDTM, ADaM), Safety data marts is required Experience of FHIR, HL7, USDM is preferred. Experience of Data mapping and transformation in clinical data using various tools like TAMR ,Oracle LSH etc Experience of generating SDTM, ADaM datasets as part of statistical programming deliverables of clinical trials. Experience of designing clinical data models as part of SDTM, ADaM or safety data marts for submission or exploratory analysis Experience of building usecases like safety signal detection, reverse translation research, combination therapy exploration for exploratory analysis for clinical data of cross study Experience of working in any of Clinical trial design, data management, analytics, 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 preferred. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams 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 Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred.
