223 Veeva Jobs - Page 7

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for? Adaptable and flexible Ability to perform under pressure Problem-solving skills Detail orientation Ability to establish strong client relationship Roles and Responsibilities: Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred.

Experience in Life Sciences, Pharmaceuticals, or Healthcare industry. Agile and veeva vault

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Hi, We are hiring for ITES Company for SDTM Programmer Role. Job description: Minimum 2 years of experience for Senior Statistical programming is a mandate. Having strong understanding of SAS Base/Macros/GTL and experience of SDTM/ADAM/TLFs creation as per CDISC standards. Associate should be able to manage communication with customers, track and ensure quality on-time deliverables Implementation of process improvements for enhanced quality and efficiency gains, institute robust processes to ensure consistent outcomes with quicker turn-around time. Experience in SDTM, ADAM & TLF Experience in EDC & VEEVA Expertise in Base and Advance SAS programming. Expertise in developing macros and developing generalized programs. Development of the complex SAS macros that can be utilized across TAs in multiple studies, review of the developed SAS programs. Expertise in SQL, SAS Macros, Functions, SAS GTL, SAS, and other advanced SAS components. Mentor and supervise developers to build generic standard macros, generic listings or other ad-hoc requests in accordance with business requirements Key Skills: a) Minimum 2 years of Experience in SDTM, ADAM & TLF is must b) Any Graduate To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Indore Search : Job Code # 228 b) For Position in Ahmedabad Search : Job Code # 229

Hi, We are hiring for Leading ITES Company for Validation Associate Profile. Job Description Minimum 3 years as a Validation Associate is required. 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification (DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through the entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failures. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenarios. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare the InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slice variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets Document inconsistencies Key Skills: a) Min 2 years of experience in eDC or non eDC b) Edit checks validation & script creation in any eDC systems like InForm, Veeva, Rave is required c) Any Graduate WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 173 b) For Position in Ahmedabad Search : Job Code # 175

Databriks + Pyspark About The Role 1 Skill:Databriks + Pyspark Exp 5 to 8 yr Location Any PSL , Bangalore, Delhi, Pune , Chennai Dont look for Hyderabad Location Azure Data bricks,PySpark,Oracle PL SQL,ETL,SQL,Data Integration Data Engineer - Data AnalystSummaryStrategically manages and maintains corporate global clinical data for all major business units, while ensuring data quality and integrity. Provides system support, testing, and training for applications accessing clinical data.Proven 2-5 years work experience as a Data Analyst in Clinical data Identifies, investigates, and resolves data quality issues, communicating with business units and IT and performing root cause analysis as necessary.Experience in Clinical data Veeva, CTMS, EDC and other clinical applicationsExperience in Azure Databricks Pyspark, ETL Dev.Strong Knowledge of in SQL, Relational data models and data movementResponsible for validating new and updated Clinical data as it feeds into the Warehouse from applications to ensure accuracy, including company research, cleansing, and merging data.Performs ongoing profiling and analysis of the clinical data and serves as a subject matter expert for clinical data.Drives initiatives to improve enterprise data integrity and process efficiencyCollaborates with IT to support the development and implementation of changes, issue resolution, enhancements, and data integration projects. Location - Chandigarh,Dadra & Nagar Haveli,Daman,Diu,Goa,Haveli,Jammu,Lakshadweep,Nagar,New Delhi,Puducherry,Sikkim

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva CRM Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : B E Summary :As an Application Developer, you will be responsible for designing, building, and configuring applications to meet business process and application requirements using Veeva CRM. Your typical day will involve collaborating with cross-functional teams, analyzing business requirements, and developing solutions to meet those requirements. Roles & Responsibilities: Design, build, and configure applications to meet business process and application requirements using Veeva CRM. Collaborate with cross-functional teams to analyze business requirements and develop solutions to meet those requirements. Develop and maintain technical documentation related to application development. Provide technical support and troubleshooting for applications developed using Veeva CRM. Stay updated with the latest advancements in Veeva CRM and related technologies. Professional & Technical Skills: Must To Have Skills:Strong experience in Veeva CRM. Good To Have Skills:Experience in Salesforce CRM, Apex, and Visualforce. Experience in designing, building, and configuring applications using Veeva CRM. Strong understanding of software development life cycle (SDLC) and agile methodologies. Experience in developing and maintaining technical documentation. Excellent problem-solving and troubleshooting skills. Additional Information: The candidate should have a minimum of 5 years of experience in Veeva CRM. The ideal candidate will possess a strong educational background in computer science or a related field, along with a proven track record of delivering impactful solutions using Veeva CRM. This position is based at our Chennai office. Qualification B E

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva CRM Good to have skills : NA Minimum 2 year(s) of experience is required Educational Qualification : Regular 15 years of education Summary :As an Application Developer, you will be responsible for designing, building, and configuring applications to meet business process and application requirements using Veeva CRM. Your typical day will involve collaborating with cross-functional teams, developing and testing software solutions, and ensuring the quality of the final product. Roles & Responsibilities: Design, develop, and test software solutions using Veeva CRM to meet business process and application requirements. Collaborate with cross-functional teams to identify and prioritize software requirements. Ensure the quality of the final product by conducting thorough testing and debugging. Stay updated with the latest advancements in Veeva CRM and related technologies, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Proficiency in Veeva CRM. Good To Have Skills:Experience with Salesforce, Apex, and Visualforce. Strong understanding of software development principles and methodologies. Experience with Agile development methodologies. Solid grasp of software testing and debugging techniques. Additional Information: The candidate should have a minimum of 2 years of experience in Veeva CRM. The ideal candidate will possess a strong educational background in computer science or a related field, along with a proven track record of delivering impactful software solutions. This position is based at our Hyderabad office. Qualifications Regular 15 years of education

Project Role : User Experience Lead Project Role Description : Lead prototype work and other software engineering solutions that create an optimized user experience. Translate design concepts to prototype solutions as quickly and tangibly as possible, with a balanced understanding of technical feasibility implications and design intent. Must have skills : Veeva CRM Good to have skills : NA Minimum 7.5 year(s) of experience is required Educational Qualification : Graduate Summary :As a User Experience Lead for Packaged Application Development, you will be responsible for leading prototype work and other software engineering solutions that create an optimized user experience. Your typical day will involve translating design concepts to prototype solutions as quickly and tangibly as possible, with a balanced understanding of technical feasibility implications and design intent using Veeva CRM. Roles & Responsibilities: Lead the design and development of user-centered software solutions using Veeva CRM. Collaborate with cross-functional teams to ensure the delivery of high-quality software solutions that meet user needs and business requirements. Translate design concepts to prototype solutions as quickly and tangibly as possible, with a balanced understanding of technical feasibility implications and design intent. Provide technical leadership and mentorship to team members, ensuring adherence to best practices and standards for software development. Stay updated with the latest advancements in user experience design and development, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Veeva CRM. Good To Have Skills:Experience with other CRM platforms. Strong understanding of user experience design principles and best practices. Experience with software development methodologies and tools, including Agile and JIRA. Excellent communication and collaboration skills, with the ability to work effectively in a team environment. Additional Information: The candidate should have a minimum of 7.5 years of experience in Veeva CRM. The ideal candidate will possess a strong educational background in computer science, human-computer interaction, or a related field, along with a proven track record of delivering impactful user-centered software solutions. This position is based at our Bengaluru office. Qualifications Graduate

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva Vault Good to have skills : NA Minimum 3 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Developer, you will be responsible for designing, building, and configuring applications to meet business process and application requirements. You will work closely with the team to ensure the successful delivery of high-quality solutions. Your typical day will involve collaborating with stakeholders to gather requirements, designing and developing application components, and conducting testing and debugging to ensure optimal performance and functionality. Roles & Responsibilities: Expected to perform independently and become an SME. Required active participation/contribution in team discussions. Contribute in providing solutions to work related problems. Collaborate with stakeholders to gather and analyze requirements. Design and develop application components based on business process and application requirements. Conduct testing and debugging to ensure optimal performance and functionality. Provide technical guidance and support to team members. Stay updated with the latest industry trends and technologies. Assist in troubleshooting and resolving application issues. Ensure adherence to coding standards and best practices. Professional & Technical Skills: Must To Have Skills:Proficiency in Veeva Vault. Strong understanding of software development principles and methodologies. Experience in designing and building applications. Knowledge of database management systems and SQL. Familiarity with web technologies such as HTML, CSS, and JavaScript. Additional Information: The candidate should have a minimum of 3 years of experience in Veeva Vault. This position is based at our Bengaluru office. A 15 years full time education is required. Qualification 15 years full time education

Job description Good experience in Veeva Vault CRM, Objects configurations and Access Control Management. Strong experience in Veeva vault API integrations and Authentication mechanisms. Good understanding of HCP Engage Services, Data Integrations and Publish expertise. Review of asset metadata and related configurations in Veeva DAMS Experience in Packaging, Completeness and follow internal specifications (naming conventions, size, etc..). Good understanding of Veeva vault best practices and integration standards. Maintenance of Digital Assets/Objects in Veeva vault • Tracking of expired assets • Expiry management • licensing extension • Keyword management A White belt certified On Veeva Vault platform will be a plus.

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva CRM Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : BTech Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. Your typical day will involve collaborating with the team to develop and implement solutions, ensuring the applications are aligned with business needs and requirements. You will also be responsible for troubleshooting and resolving any application issues that arise, as well as staying up-to-date with the latest industry trends and technologies to continuously improve the applications. Roles & Responsibilities: Expected to be an SME, collaborate and manage the team to perform. Responsible for team decisions. Engage with multiple teams and contribute on key decisions. Provide solutions to problems for their immediate team and across multiple teams. Develop and maintain high-quality software code. Participate in code reviews to ensure code quality and adherence to coding standards. Collaborate with cross-functional teams to gather requirements and design solutions. Conduct unit testing and debugging of applications to ensure proper functionality. Professional & Technical Skills: Must To Have Skills:Proficiency in Veeva CRM. Strong understanding of software development principles and methodologies. Experience in designing and developing applications using Veeva CRM. Knowledge of web technologies such as HTML, CSS, and JavaScript. Familiarity with relational databases and SQL. Good To Have Skills:Experience with Salesforce CRM. Experience with agile development methodologies. Knowledge of integration technologies such as REST and SOAP APIs. Additional Information: The candidate should have a minimum of 5 years of experience in Veeva CRM. This position is based at our Kolkata office. A BTech degree is required. Qualification BTech

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva CRM Good to have skills : NA Minimum 3 year(s) of experience is required Educational Qualification : Regular 15 Years of education Summary :As an Application Developer for Veeva CRM, you will be responsible for designing, building, and configuring applications to meet business process and application requirements. Your typical day will involve working with Veeva CRM, collaborating with cross-functional teams, and delivering impactful solutions to meet business needs. Roles & Responsibilities: Lead the design, development, and implementation of Veeva CRM applications to meet business process and application requirements. Collaborate with cross-functional teams to identify and prioritize business needs, and develop solutions that meet those needs. Configure and customize Veeva CRM applications to meet specific business requirements. Provide technical expertise and guidance to team members, and ensure that best practices are followed throughout the development process. Professional & Technical Skills: Must To Have Skills:Strong experience in Veeva CRM development. Good To Have Skills:Experience with Salesforce, Apex, and Visualforce. Solid understanding of software development life cycle (SDLC) methodologies. Experience with Agile development methodologies. Strong problem-solving and analytical skills. Additional Information: The candidate should have a minimum of 3 years of experience in Veeva CRM development. The ideal candidate will possess a strong educational background in computer science or a related field, along with a proven track record of delivering impactful solutions. This position is based at our Bengaluru office. Qualification Regular 15 Years of education

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva CRM Good to have skills : NA Minimum 3 year(s) of experience is required Educational Qualification : Regular 15 Years of education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. You will be responsible for developing and implementing software solutions using Veeva CRM. Your typical day will involve collaborating with cross-functional teams, analyzing business requirements, and designing and coding applications to enhance business processes and improve user experience. Roles & Responsibilities: Expected to perform independently and become an SME. Required active participation/contribution in team discussions. Contribute in providing solutions to work-related problems. Design, develop, and test Veeva CRM applications based on business requirements. Collaborate with cross-functional teams to gather and analyze business requirements. Participate in code reviews and provide feedback to improve code quality. Troubleshoot and debug application issues to ensure smooth functionality. Document technical specifications and user guides for developed applications. Stay updated with the latest industry trends and technologies related to Veeva CRM. Provide technical support and guidance to end-users. Assist in the deployment and maintenance of Veeva CRM applications. Professional & Technical Skills: Must To Have Skills:Proficiency in Veeva CRM. Good To Have Skills:Experience with Salesforce CRM. Strong understanding of software development principles and methodologies. Experience in designing and developing applications using Veeva CRM. Knowledge of Veeva CRM configuration and customization. Familiarity with Veeva CRM data model and integration capabilities. Experience in troubleshooting and resolving Veeva CRM application issues. Excellent problem-solving and analytical skills. Additional Information: The candidate should have a minimum of 3 years of experience in Veeva CRM. This position is based at our Hyderabad office. A Regular 15 Years of education is required. Qualification Regular 15 Years of education

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva CRM Good to have skills : NA Minimum 3 year(s) of experience is required Educational Qualification : Regular 15 Years of education Summary :As an Application Developer, you will design, build, and configure applications to meet business process and application requirements. You will be responsible for developing and implementing software solutions using Veeva CRM. Your typical day will involve collaborating with cross-functional teams, analyzing business requirements, and designing and coding applications to enhance business processes and improve user experience. Roles & Responsibilities: Expected to perform independently and become an SME. Required active participation/contribution in team discussions. Contribute in providing solutions to work-related problems. Design, develop, and test Veeva CRM applications based on business requirements. Collaborate with cross-functional teams to gather and analyze business requirements. Participate in code reviews and provide feedback to improve code quality. Troubleshoot and debug application issues to ensure smooth functionality. Document technical specifications and user guides for developed applications. Professional & Technical Skills: Must To Have Skills:Proficiency in Veeva CRM. Good To Have Skills:Experience with Salesforce CRM. Strong understanding of software development principles and methodologies. Experience in designing and developing applications using Veeva CRM. Knowledge of web technologies such as HTML, CSS, and JavaScript. Familiarity with relational databases and SQL. Ability to troubleshoot and debug complex software applications. Excellent problem-solving and analytical skills. Additional Information: The candidate should have a minimum of 3 years of experience in Veeva CRM. This position is based at our Hyderabad office. A Regular 15 Years of education is required. Qualifications Regular 15 Years of education

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Veeva CRM Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : Regular 15 years of education Summary :As an Application Lead for Veeva CRM, you will be responsible for leading the effort to design, build, and configure applications. You will act as the primary point of contact and work closely with cross-functional teams to ensure successful project delivery. Your typical day will involve utilizing your expertise in Veeva CRM to develop and implement solutions that meet business requirements. Roles & Responsibilities: Lead the design, development, and implementation of Veeva CRM solutions, ensuring adherence to best practices and standards. Act as the primary point of contact for all Veeva CRM-related activities, collaborating with cross-functional teams to ensure successful project delivery. Provide technical guidance and mentorship to team members, ensuring the development of high-quality solutions that meet business requirements. Develop and maintain project plans, timelines, and budgets, ensuring timely and successful project delivery. Stay up-to-date with the latest advancements in Veeva CRM and related technologies, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Veeva CRM. Good To Have Skills:Experience with Salesforce.com, Apex, and Visualforce. Strong understanding of software development methodologies, including Agile and Waterfall. Experience with project management tools such as JIRA or Trello. Excellent communication and interpersonal skills, with the ability to effectively communicate technical information to both technical and non-technical stakeholders. Additional Information: The candidate should have a minimum of 5 years of experience in Veeva CRM. The ideal candidate will possess a strong educational background in computer science or a related field, along with a proven track record of delivering impactful solutions. This position is based at our Bengaluru office. Qualifications Regular 15 years of education

SAP ATTP Functional Consultant Roles and Responsibilities Experience with Pharma industry Global Track and Trace Serialization system and deployments, including hands on experience implementing SAP ATTP. Minimum 3 years of working Exposure in SAP ATTP configurations, Master Data management, Supply Chain Notification, Regulatory Reporting and ECC Integration. Business process Knowledge Pharmaceutical products packaging, aggregation, Barcode printing, and verification. Working experience on CMO & MAH onboardings. Integration Knowledge from ECC to ATTP system (Master Data, Batch & Transaction Data integration). Knowledge in GS1 standards (GTIN, SGTIN, GLN, SGLN, SSCC, GCP). Good understanding of ECC modules SD & WM. Good understanding of the generic reporting functionality in ATTP system. Perform detailed analysis of complex business process requirements and provide appropriate system solutions; identify, interpret, validate and document customer requirements. Map client business requirements, processes and objectives; develops necessary product modifications to satisfy clients' needs. Documentation of functional designs, test cases and results Design, customize, configure and testing of the module. Handle changes or emergency transports as needed for high priority issues. Working Exposure in BAU Support project/understanding SLA process and Ticket handling Skill Requirement Minimum of 3 years exp in SAP ATTP module working experience and key integration points between the other SAP modules (SD and WM experience is an asset). Experience with one implementation project will add an asset. Integration Knowledge with middleware systems SAP ICH & SAP PO Tools Veeva, ALM, Solman, Service Now Good Understanding of ITIL concepts (Incident, Change, Problem, Request Management) Pharmaceutical Experience is preferred. Good Communication Skills Handling Customer Escalations Good Collaboration with external stakeholders

ZS life science R&D team partners with client to discover and develop innovative medicines that improve patient's lives. Our work spans across consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professional that are delivering R&D programs, $100MM+ invested in R&D data, analytics and technology assets and 100+ clients on R&D programs. Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in the 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. 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, 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 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 Youll Bring Bachelors degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Masters 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.

Working with Us Challenging Meaningful Life-changing Those aren't words that are usually associated with a job But working at Bristol Myers Squibb is anything but usual Here, uniquely interesting work happens every day, in every department From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity Take your career farther than you thought possible Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives Read more: careers bms com/working-with-us ETMF SpecialistJob Description Date Modified:05 November 2024 Job Title: eTMF Specialist Division: Research & Development Functional Area Description: Global Development Operations / Trial Delivery Support / TMF & Transparency Position Summary /Objective This individual contributor role has the main responsibility for document upload and management in the electronic Trial Master File (eTMF) in support of BMS Clinical Trials across the enterprise Position Responsibilities Responsible for managing and executing centralized activities supporting global trials with emphasis on clinical documentation Upload and perform rigorous quality reviews of electronic documents residing in the eTMF system to ensure they are inspection-ready and are compliant with the ALCOA Plus principles Apply filing attributes/metadata as appropriate/required to documents to facilitate classification, management, identification, and accessibility to retrieve files Provide immediate feedback for any quality Issue findings Interact with regional roles, the study team and other functional areas within BMS to manage document quality, timeliness and completeness and provide support to the study team throughout the study duration (start-up, maintenance, and close-out of clinical studies) Develops and maintains collaborative working relationships with clinical study teams Review of essential regulatory documentation, including submission of final documents to the eTMF May provide a level of quality control of start-up activities Act as a single point of contact for the study team for centralized activities related to document management Ongoing maintenance and tracking of essential records and collection of updated/outstanding documentation Proactively resolve issues related to missing or expired documents Ongoing communication with study teams regarding centralized document management activities Other duties are assigned to support Clinical Trials Degree Requirements Minimum of a bachelor's degree in Life science, Business Administration, or equivalent experience Advance degree a plus Experience Requirements 1-2 years of relevant experience in clinical trial documentation management or a Clinically related or relevant field Demonstrated knowledge of ICH / GCP and regulatory guidelines/directives, understanding of drug development process and Pharma Experience in the use of industry Clinical Trial Master File Systems or equivalent Experience with Veeva Vault Clinical preferred Experience with MS office suite, SharePoint, etc CTMS (Veeva Vault experience preferred), knowledge of portals, databases and other Clinical Trial enabling technologies Proven experience in managing key internal and external stakeholders effectively by frequently soliciting input and gathering and incorporating feedback into processes as appropriate Key Competency Requirements Strong organizational, time-management, analytical and decision-making skills to efficiently evaluate, plan and accomplish work goals Effective management or support of cross-functional, multi-cultural teams and demonstrated ability to work and influence within a matrix structure Proven time management skills and ability to be flexible to meet job demands, manage multiple priorities, and take on new initiatives and improvement efforts Ability to sustain high levels of performance in a constantly changing environment Demonstrates a high level of adaptability in dealing with ambiguous and complex work environment and balances multiple demands on role in a responsive and professional manner Ability to prioritize work and assess risk to meet the needs of the organization Demonstrated ability to work independently and seek out support when needed Proactive, adaptable and able to modify personal and organizational work style to meet the needs of the business Exceptional written and oral communication skills " Travel Required: No Describe Exposure to Any Hazards/Disagreeable Conditions in the Work Environment: N/A If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway You could be one step away from work that will transform your life and career Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as Transforming patients' lives through science, every BMS employee plays an integral role in work that goes far beyond ordinary Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues On-site Protocol Responsibilities BMS has a diverse occupancy structure that determines where an employee is required to conduct their work This structure includes site-essential, site-by-design, field-based and remote-by-design jobs The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms com Visit careers bms com/ eeo -accessibility to access our complete Equal Employment Opportunity statement BMS cares about your well-being and the well-being of our staff, customers, patients, and communities As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers bms com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations

Hiring For Top Brand For EDC Veeva Programmer Must Have Experience in Veeva with edit checks programming Experience Required : 2 to 8 Years Of Experience Location : Hyderabad Education : Life Science Graduates Only Required Candidate profile Candidate with Experience in Veeva with edit checks programming. WhatsApp CV to Bhavya - 8287377768 and mention EDC

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : Veeva CRM Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : Regular 15 years of education Summary :As an Application Lead for Veeva CRM, you will be responsible for leading the effort to design, build, and configure applications. You will act as the primary point of contact and work closely with cross-functional teams to ensure successful project delivery. Your typical day will involve utilizing your expertise in Veeva CRM to develop and implement solutions that meet business requirements. Roles & Responsibilities: Lead the design, development, and implementation of Veeva CRM solutions, ensuring adherence to best practices and standards. Act as the primary point of contact for all Veeva CRM-related activities, collaborating with cross-functional teams to ensure successful project delivery. Provide technical guidance and mentorship to team members, ensuring the development of high-quality solutions that meet business requirements. Develop and maintain project plans, timelines, and budgets, ensuring timely and successful project delivery. Stay up-to-date with the latest advancements in Veeva CRM and related technologies, integrating innovative approaches for sustained competitive advantage. Professional & Technical Skills: Must To Have Skills:Expertise in Veeva CRM. Good To Have Skills:Experience with Salesforce.com, Apex, and Visualforce. Strong understanding of software development methodologies, including Agile and Waterfall. Experience with project management tools such as JIRA or Trello. Excellent communication and interpersonal skills, with the ability to effectively communicate technical information to both technical and non-technical stakeholders. Additional Information: The candidate should have a minimum of 5 years of experience in Veeva CRM. The ideal candidate will possess a strong educational background in computer science or a related field, along with a proven track record of delivering impactful solutions. This position is based at our Bengaluru office. Qualification Regular 15 years of education

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva CRM Good to have skills : NA Minimum 3 year(s) of experience is required Educational Qualification : Regular 15 Years of education Summary :As an Application Developer for Veeva CRM, you will be responsible for designing, building, and configuring applications to meet business process and application requirements. Your typical day will involve working with Veeva CRM, collaborating with cross-functional teams, and delivering impactful solutions to meet business needs. Roles & Responsibilities: Lead the design, development, and implementation of Veeva CRM applications to meet business process and application requirements. Collaborate with cross-functional teams to identify and prioritize business needs, and develop solutions that meet those needs. Configure and customize Veeva CRM applications to meet specific business requirements. Provide technical expertise and guidance to team members, and ensure that best practices are followed throughout the development process. Professional & Technical Skills: Must To Have Skills:Strong experience in Veeva CRM development. Good To Have Skills:Experience with Salesforce, Apex, and Visualforce. Solid understanding of software development life cycle (SDLC) methodologies. Experience with Agile development methodologies. Strong problem-solving and analytical skills. Additional Information: The candidate should have a minimum of 3 years of experience in Veeva CRM development. The ideal candidate will possess a strong educational background in computer science or a related field, along with a proven track record of delivering impactful solutions. This position is based at our Bengaluru office. Qualification Regular 15 Years of education

Project Role : Integration Engineer Project Role Description : Provide consultative Business and System Integration services to help clients implement effective solutions. Understand and translate customer needs into business and technology solutions. Drive discussions and consult on transformation, the customer journey, functional/application designs and ensure technology and business solutions represent business requirements. Must have skills : Veeva Vault Good to have skills : NA Minimum 5 year(s) of experience is required Educational Qualification : NA Summary :As an Integration Engineer, you will be responsible for providing consultative Business and System Integration services to help clients implement effective solutions. Your typical day will involve understanding and translating customer needs into business and technology solutions, driving discussions and consult on transformation, the customer journey, functional/application designs and ensuring technology and business solutions represent business requirements. Roles & Responsibilities: Lead the design, development, and implementation of Veeva Vault solutions for clients. Provide technical expertise and guidance to clients on Veeva Vault integration with other systems. Collaborate with cross-functional teams to ensure successful delivery of Veeva Vault solutions. Develop and maintain technical documentation related to Veeva Vault solutions. Professional & Technical Skills: Must To Have Skills:Strong experience in Veeva Vault. Good To Have Skills:Experience in other Life Sciences applications such as Salesforce, Oracle Clinical, or Argus Safety. Experience in designing and implementing Veeva Vault solutions. Strong understanding of Veeva Vault integration with other systems. Experience in developing technical documentation related to Veeva Vault solutions. Additional Information: The candidate should have a minimum of 5 years of experience in Veeva Vault. The ideal candidate will possess a strong educational background in Computer Science or a related field, along with a proven track record of delivering impactful Veeva Vault solutions. This position is based at our Bengaluru office. Qualifications NA

Key Responsibilities and Core Competencies: You will be responsible for managing and delivering multiple Pharma projects. Leading a team of atleast 8 members, resolving their technical and business related problems and other queries. Responsible for client interaction; requirements gathering, creating required documents, development, quality assurance of the deliverables. Good collaboration with onshore and Senior folks. Should have fair understanding of Data Capabilities (Data Management, Data Quality, Master and Reference Data). Exposure to Project management methodologies including Agile and Waterfall. Experience working in RFPs would be a plus. Required Technical Skills: Proficient in Python, Pyspark, SQL Extensive hands-on experience in big data processing and cloud technologies like AWS and Azure services, Databricks etc. Strong experience working with cloud data warehouses like Snowflake, Redshift, Azure etc. Good experience in ETL, Data Modelling, building ETL Pipelines. Conceptual knowledge of Relational database technologies, Data Lake, Lake Houses etc. Sound knowledge in Data operations, quality and data governance. Preferred Qualifications: Bachelors or masters Engineering/ MCA or equivalent degree. 7-9 years of experience as Data Engineer, with atleast 2 years in managing medium to large scale programs. Minimum 5 years of Pharma and Life Science domain exposure in IQVIA, Veeva, Symphony, IMS etc. High motivation, good work ethic, maturity, self-organized and personal initiative. Ability to work collaboratively and providing the support to the team. Excellent written and verbal communication skills. Strong analytical and problem-solving skills.

Project Role : Application Developer Project Role Description : Design, build and configure applications to meet business process and application requirements. Must have skills : Veeva CRM Good to have skills : NA Minimum 3 year(s) of experience is required Educational Qualification : Regular 15 Years of education Summary :As an Application Developer for Veeva CRM, you will be responsible for designing, building, and configuring applications to meet business process and application requirements. Your typical day will involve working with Veeva CRM, collaborating with cross-functional teams, and delivering impactful solutions to meet business needs. Roles & Responsibilities: Lead the design, development, and implementation of Veeva CRM applications to meet business process and application requirements. Collaborate with cross-functional teams to identify and prioritize business needs, and develop solutions that meet those needs. Configure and customize Veeva CRM applications to meet specific business requirements. Provide technical expertise and guidance to team members, and ensure that best practices are followed throughout the development process. Professional & Technical Skills: Must To Have Skills:Strong experience in Veeva CRM development. Good To Have Skills:Experience with Salesforce, Apex, and Visualforce. Solid understanding of software development life cycle (SDLC) methodologies. Experience with Agile development methodologies. Strong problem-solving and analytical skills. Additional Information: The candidate should have a minimum of 3 years of experience in Veeva CRM development. The ideal candidate will possess a strong educational background in computer science or a related field, along with a proven track record of delivering impactful solutions. This position is based at our Bengaluru office. Qualifications Regular 15 Years of education