Job
Description
Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in drug development. The Drug Development RD 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. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, Clinical data management, and analytics systems. Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process. What Youll Do: You will design implement various innovative solutions in the realms of Clinical data management, analytics Work in clinical data management and analytics area as part of strategy building, assessment and technology implementation project as business and data analyst Lead and participate in clinical business process discussions with clients, identify requirements and user stories Conduct online interviews and workshops to gather requirements to support the business needs of users Author high-level user stories and develop related tasks, acceptance criteria and review test cases Participate in clinical business process discussions with clients, identify requirements and user stories Work closely with project teams in creating Requirement Specifications, RTM and other project documents Plan and facilitate various Agile meetings and artefacts, including sprint planning, review retrospectives, daily stand-ups Perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules The ideal candidate will have a strong background in the project lifecycle, with experience in large and complex programs. They will have a track record of successfully managing people, and be able to provide support and escalation routes for queries, define and plan analysis deliverables, and agree on analysis approaches. Experience in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community is also essential. What Youll Bring Bachelors degree Pharma/ Bioinformatics / Medicine or related disciplines Master's degree in Business Analyst, Engineering or Science preferred. 5-10 years of experience working within Life Science Domain as solution architect / business analyst / data analys t is required. Experience of working in building solution around drug development - clinical data management areas like discrepancy management, clinical data repositories, clinical issue management, Operational data repositories, operational reports Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Experience working in Clinical data management area as BA or Subject matter expert Understand the end to end process for clinical data management and Analysis Exposure to clinical data coordination and clinical data management area. 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.
