4 Metadata Repository Jobs

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, our most valuable asset is our people. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers, and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning; bold ideas; courage and passion to drive life-changing impact to ZS. At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systemsthe ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are part of your success here. Learn more about our diversity, equity, and inclusion efforts and the networks ZS supports to assist our ZSers in cultivating community spaces, obtaining the resources they need to thrive, and sharing the messages they are passionate about. **What You'll Do** - Design & implement various innovative solutions in the realms of clinical trial, data management, analytics. - Work in designing a common data model based on clinical standards like SDTM / ADaM / ISS / ISE. - Design safety data mart for cross-study analysis and exploratory analysis. - Build analysis-ready datasets that serve various safety and exploratory use cases across clinical trials. - Experience in building use cases 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. - Support leaders in engaging with clients to review clinical data models, determining requirements, establishing safety use cases, and delivering solutions that have a significant impact. - Lead requirements gathering activities and collaborate with the product owner to prioritize and groom the backlog to ensure an appropriate level of detail is captured at the right time. - Review and author high-level user stories and develop related tasks, acceptance criteria, and review test cases. - Work closely with project teams in creating requirement specifications, requirement traceability metrics, user guides, and other project requirement documents. - Plan and facilitate various requirement gathering, solution meetings, and artifacts. - Create process flows based on client and internal project discussions. - Perform business process modeling, data flow, user experience modeling, and basic solution architecture diagramming. - Build 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 the Life Science Domain as a 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 use cases 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 the 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 programs is required. - Exposure to programming languages like R, Python, and SAS is preferred. **Perks & Benefits** ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth, and professional development. Our robust skills development programs, multiple career progression options, and internal mobility paths and collaborative culture empower you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. **Travel** Travel is a requirement at ZS for client-facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. **Considering applying ** At ZS, we're building a diverse and inclusive company where people bring their passions to inspire life-changing impact and deliver better outcomes for all. We are most interested in finding the best candidate for the job and recognize the value that candidates with all backgrounds, including non-traditional ones, bring. If you are interested in joining us, we encourage you to apply even if you don't meet 100% of the requirements listed above. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. **To Complete Your Application** Candidates must possess or be able to obtain work authorization for their intended country of employment. An online application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. **Find Out More At:** www.zs.com,

Job Title: Clinical Standard and Bio Stats Job Location: Pan India (Preferrable: Delhi or Mumbai) Exp Range: 10 - 18 Years Job Description: Roles and Responsibility: Contributes in building Product and solutions in Digital Data Flow, along with Product Team by providing Subject Matter expertise and knowledge on Industry Trends. Contributes to build differentiated Product offerings to maximize Sales and increase number of customers on Product. Co-leads the global strategic positioning & roadmap from a business view for Clinical Standards, Digital Data Flow, Metadata Repository, Biometrics e.g. SDTM, ADaM, Regulatory Submission Packages and Data Management (EDC, non-CRF, eDTA), TFLs, SDR, USDM (e.g. STDM, ADaM.) Co-leads the design & development for these solutions from a business view Co-leads thought leaderships and external visibility (e.g. articles, webinars, conferences, cross-industry meetings), initiates advisory boards Supports business development team with customer presentations, RFI/RFP requests and go-to-market strategy. Initiates customer leaderships connects and strategic partnerships. Description: At least 7-18 years of global drug development experience in Digital Data Flow, metadata repository, clinical data standards, biometrics, EDC, eDTA, gained preferably at top-15 pharma companies or clinical research organizations (CROs) Extensive hands-on experience with Digital Data Flow, data collection standards, biostatistical programming, STDM, ADaM, TFL and regulatory submission packages, including innovative tools and strategies for automation. Experience in applying AI in standardization, SDTM, ADaM and TFL generation. Experience in strategy setting for generating EDC build from study protocol, SDR Model, USDM Experience in innovative ways to automate testing and validation Track record of building respect and trust with customers, employees and other internal and external stakeholders and partners. Broad cross-pharma senior management network & preferably cross-industry forum expertise (e.g. CDISC, Transcelerate, IMI) Outstanding communication skills with ability to translate technology in a clear & easy-to-understand language Strong interpersonal skills including negotiation skills, facilitation skills and ability to drive for clarity and results when faced with ambiguity. Masters degree in sciences (e.g. biology, biomedical, pharmacist, statistics) or equivalent by expertise. PhD is an advantage

What you’ll do You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, 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 lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases Your team 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 Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules 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. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required. 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. 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. Additional Skills Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences. 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. Perks & Benefits ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Considering applying At ZS, we're building a diverse and inclusive company where people bring their passions to inspire life-changing impact and deliver better outcomes for all. We are most interested in finding the best candidate for the job and recognize the value that candidates with all backgrounds, including non-traditional ones, bring. If you are interested in joining us, we encourage you to apply even if you don't meet 100% of the requirements listed above. To Complete Your Application Candidates must possess work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. Find Out More At www.zs.com

What you’ll do - 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.