single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; Overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). Essential Functions Gather Study Set up requirements through discussion and communication with relevant stakeholders. With Minimal guidance - support, overview of validation of new Device integrations. Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor. Ensure that all the deliverables are of expected quality standards and meet customer expectations. With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW). Support Training of New joiners. Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings. Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required. With Guidance manage & oversight the implementation of new technology / database revisions. Work closely with the programming team for process innovation and automation. Be compliant to trainings and eSOP reading. Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions. Communication with Line Manager, and other team members across functions should be collaborative. Perform other duties as directed by Line Manager. Qualifications Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req 3 -4 years direct Data Management experience, including a minimum of 1 year as a CDM project lead. Pref English Fluency Spoken and English Advanced Advanced computer applications like Microsoft excel, word, Inbox etc Advanced Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Job Overview Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Qualifications Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Job Title / Primary Skill: Clinical DB Validation Specialist Years of Experience: 2-5 Years Job Location: Kochi/Kolkata/Bangalore/Hyderabad Must Have Skills: data management, rave, start up, validation Good To Have Skills: Rave Job Description Conduct testing activities and provide comprehensive testing expertise to produce efficient, quality database that meets customer requirements. Provide support in creation of Test Plan and handling of validation projects. May act as Validation Team Lead. May undertake selected team leadership activities under supervision of Manager. Independently conduct testing activities to validate Edit Checks, other components, SAS listings, Transfer program and custom reports in platforms like Inform, RAVE, OCRDC, Oracle Clinical. Should have high expertise in Testing activities and excellent knowledge of Database. Advanced understanding of database structures. Perform eCRF and Time & Events QC as per QC checklist. Provide support to Validation Team Leads as required and contribute towards creation of test cases, documentation and communication with internal customers. Support Validation Team Lead in overall management of validation projects. May take complete responsibility for delivery of a validation project. Understand all the documentation requirements with regards to validation very well and update all relevant documents in a timely manner. May monitor documentation compliance for junior team members. Ensure validation processes and best practices are being followed strictly by self and team. May assist with creation/review of now processes/best practices. Communicate status of the projects to the Validation team Lead/Manager/ Data Team Lead/Programmer. Support Validation Team Lead/Manager with daily tasks allocation for validation projects. Escalate problems to the attention of the Validation team Lead or Manager. Conduct Quality Reviews of Testing projects on an ongoing basis as applicable. Conduct Knowledge Sharing and Lessons Learnt sessions regularly. Review and update relevant documents accurately and completely on time. May document all testing documentation in eDMSF. May serve as Subject Matter Expert (SME). Mentor Associate Validation Analysts/Validation Analysts in all validation activities. May provide metrics support to Validation Team Lead or Manager. • Professional Attributes Identify areas for process improvements continuously. Actively take part and contribute towards process improvement initiatives s assigned besides providing suggestions/ideas for continuous improvement of the process. Understand and comply with core Operating Procedures and Work Instructions (including Best Practice and Guidance documents). Meet project objectives as assigned by Validation Team Lead or Manager. Develop and maintain good communication and working relationships with validation teams across sites. Educational Qualification: Bachelor's Degree bachelor's in science/computer science/Information Technology or bachelor's in technology Req
Job Title / Primary Skill: Data Team Lead Years of Experience: 9-12 Years Job Location: Kochi/Kolkata Must Have Skills: Clinical data management, conduct, closeout, start up, SSU, Study lead Good To Have Skills: Rave Job Description 9+ of direct Data Management experience with a minimum of 2 year as a CDM project lead Pref Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Data Management (DM) team to provide high quality data management products that meet customer needs. Provide leadership to the team in the areas of project planning, execution, and close-out; Overview of financial management for data management activities; communications; and milestone deliverables. Perform role of Data Team Lead (DTL). • Gather Study Set up requirements through discussion and communication with relevant stakeholders. • With Minimal guidance - support, overview of validation of new Device integrations. • Oversight & Perform regular Data cleaning activities to ensure clean data with quality and timely deliverables to sponsor. • Ensure that all the deliverables are of expected quality standards and meet customer expectations. • With guidance, ensure service and quality meet agreed upon timelines and deliverables in contract/Scope of Work (SOW). • Support Training of New joiners. • Lead internal study meetings and internal/ sponsor audits and participate in Study Kick off meetings and other sponsor meetings. • Tracks and manages the projects, oversee project progress, identify risks and take corrective action to rectify any errors as recommended as required. • With Guidance manage & oversight the implementation of new technology / database revisions. • Work closely with the programming team for process innovation and automation. • Be compliant to trainings and eSOP reading. • Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions. • Communication with Line Manager, and other team members across functions should be collaborative. • Perform other duties as directed by Line Manager. Professional Attributes Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Advanced computer applications like Microsoft excel, word, Inbox etc Advanced Should have Advanced understanding of Drug development lifecycle and Overall Clinical research process Advanced Educational Qualification: Bachelor's Degree In health, clinical, biological or mathematical sciences, or related field with proven experience in Data Management Req
Job Title / Primary Skill: Clinical data specialist Years of Experience: 3.5-6 Years Job Location: Kochi/Kolkata Must Have Skills: Clinical data management, data management, rave, conduct, closeout, start up Good To Have Skills: Rave Job Description Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. Undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance. Serve in the role of back-up to a DOC or DTL. Conduct data review. Write and resolve data clarifications. Lead database audit team. Develop and test databases and edit specifications. Perform testing of programming. Perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team. Professional Attributes Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Educational Qualification: Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req • Equivalent combination of education, training and experience in lieu of degree.
Bengaluru, India | Full time | Hybrid | R1521116 RESPONSIBILITIES Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems with guidance from senior staff. Building new modules and maintaining global libraries for clinical trials. Working alongside Data Management to modify existing modules & Management of a global library for a large number of projects. Good Knowledge of Data Clinical Standards, Data Models and its implementation for database and GLIB development Identifying and resolving issues which may negatively impact delivery of global library objects. Escalating issues to leadership as needed. Building, maintaining and documenting the global library objects in order to facilitate the creation of Study Level databases to collect clinical trial data. Working with the Data Managers – Study Start Up and Database Developers to implement new or modified global library objects. Work with other global librarians (GL) to understand the data requirements for collection and submission under general supervision. Support more experienced GL with the creation of metadata specifications that define the data content and structures for collection, transformation, and CDISC SDTM submission requirements, with general direction. Contribute to the review of global SOPs and business guidance/user guides directly impacting the function and providing input when applicable. Document, develop, test and maintain CDMS validations and derivations procedures using (SQL, PL/SQL, C #, VB script, SAS). With general direction, work with the Data Standards Governance team, other GL’s and/or members of the metadata team to discuss technical issues with implementation of approved collection & SDTM data structures With general direction, develop, and test all new Global/Disease level Library objects needed for clinical studies in a provisional state or equivalent in CDMS. With general direction, document, develop, review, and maintain Global Library Copy Groups for reuse of standard pages for individual trials. Recommend newly discovered practices for consideration towards the maintenance of the Global Library Conventions document for data modeling/standards and Style Guide for CDMS implementation. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Minimum 2 years clinical database programming, setup of clinical databases and CRF design experience gained in the pharmaceutical industry or CRO as well as the following: Basic CDISC Understanding: Implementation of CDISC Standards. In depth experience with RAVE (Rave certified), Global Library maintenance and procedure building including custom function programming. Good Understanding of clinical data management systems and/or relational databases as applied to clinical trials: Input to requirements for eCRF Development. Preferable knowledge of Development of validation and derivation procedures. Preferable to have any scripting language experience. Attention to detail, quality, time management and customer focus Ability to translate technical concepts for nontechnical users in the areas of CRF and validation procedure implementation in CDMS. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor’s degree, or educational equivalence, in computer/life science or related field; or equivalent combination of education, training, and experience IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Chennai, India | Full time | Hybrid | R1511352 1. Create end-user documentation which will include User Manuals, How to Do instructional manuals, Quick Reference Guides, Online Help. 2. Format and check for English language usage when required. 3. Collaborate with SMEs in various teams for knowledge transfer, for reviewing the created documents. 4. Cross-functional support when needed. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Kochi, India | Full time | Hybrid | R1478911 Job available in additional locations Job Overview Provide a wide range of medical surveillance support (including monitoring of clinical laboratory data for subjects in clinical studies and composing medical narratives and interfacing with investigator sites.) Essential Functions Monitor, and evaluate laboratory results on a daily basis from sponsor-designated central laboratory Evaluating and analyzing laboratory data at agreed frequency from sponsor-designated data management system/eDC platform Conduct preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using relevant clinical laboratory experience and compares current results with prior laboratory values to evaluate or note clinically significant increases/decreases and contacts the investigator site for pertinent additional clinical contact for distribution to project team Serve as liaison between the Medical Services Department and sponsor-designated laboratory and the IQVIA Project Team Maintain up-to-date laboratory knowledge via continuing education activities or attendance at medical seminars Based on clinical laboratory and monitoring experience, identify potentially significant trends or shifts in laboratory results and alerts IQVIA Medical Advisors Interact with project team to convey critical information that may impact study objectives Work with central laboratory staff to facilitate appropriate monitoring and reporting of subject laboratory results Assists Lead Medical Surveillance Specialist with project set-up activities Attends project team meetings, as needed Performs other related duties as assigned Qualifications Bachelor's Degree Life Sciences or allied health sciences,ie pharmacy,biochemistry, microbiology, biotechnology,nursing, biotechnology, medical laboratory sciences, physiotherapy health care ie medical (allopathy, homeopathy,ayurveda), or dentistry, 2 to 6 years relevant experience with a minimum 2.5 years of medical surveillance experience (req). r equivalent combination of education, training and experience. Strong technical ability to comprehend and integrate scientific data from a variety of sources. Strong communication skills, both written and verbal. Demonstrated computer skills, especially word processing and data management. Strong analytical and organizational skills and attention to detail required. Ability to establish and maintain effective working relationships with coworkers, managers and clients IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Job Overview Provides high quality, timely development and on-time input to solutions for service delivery, managed services, or implementation oriented client projects. Assignments range in complexity from basic analysis and problem solving to assisting in the development of more complex solutions to leading small teams. Contributes to meeting client satisfaction objectives. Develops modules and low level designs while monitoring technical quality standards of onshore / offshore developers. Essential Functions Supporting the design and build of new technology solutions including; understanding business needs, determining product specifications, production timetables, pricing, and time-integrated plans for product introduction; developing marketing strategies Conducting market research; to understand business needs and generating product requirements Managing internal and external cross functional stakeholders to support product development Leveraging business experience and acumen in identifying strategic alternatives to client questions Working in a team of like-minded professionals to create reports, presentations, workshops with client employees, management teams and other stakeholders, under the guidance our “the best on the business” team leaders Developing broad knowledge of related consulting methodologies and pharmaceutical market through the delivery of consulting engagements and participation in formal and informal learning opportunities Working independently and as part of a team Assisting development and writing of proposals with senior support Attending, supporting and presenting at client meetings Contributing to learning, development and recruiting Qualifications Bachelor's Degree Life Sciences / Economics / Business Pref Or Master's Degree Life Sciences / Economics / Business Pref Or Ph.D. With commercial experience in the healthcare industry Pref Works willingly and effectively with others in and across the organization to accomplish team goals. Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision making, growth and decline. Knowledge of consulting methods, tools and techniques, related to one’s functional area. Knowledge of current events and developments within an industry and major competitors. Knowledge and understanding of the marketplace. Knowledge of professional/trade associations, key people and companies. Effective time management skills. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Job Overview Modifies applications programs from detailed specifications. Codes, tests, debugs, documents, and maintains those programs. Essential Functions Under direct supervision, participates in conducting analysis and implementation of computer based information systems to meet specified design requirements and specifications. Investigates standard systems applications, assists in the analysis of system specifications and program coding. May participate in systems software development and maintenance. Translates detailed design specifications into computer program instructions, debugs routine programs, prepares system test data and prepares program documentation. Modifies, maintains and updates existing programs of a standard nature. Reviews potential application of programs to user need and assists in preparing feasibility studies to evaluate requirements for new and revised programs. Assists in the preparation of detailed systems design specifications to meet defined requirements. Prepares some basic block diagrams, flow charts, and associated documentation. Applies standard logic for individual applications programs and writes program instructions in a program language. Assists in the preparation of supporting procedures, forms and documentation. May identify and implement root cause fixes to program, system and/or applications errors. Qualifications Bachelor's Degree Computer Science or related discipline, or equivalent experience Req Two (2) years experience in applications programming Req IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Job Overview Modifies applications programs from detailed specifications. Codes, tests, debugs, documents, and maintains those programs. Essential Functions Under direct supervision, participates in conducting analysis and implementation of computer based information systems to meet specified design requirements and specifications. Investigates standard systems applications, assists in the analysis of system specifications and program coding. May participate in systems software development and maintenance. Translates detailed design specifications into computer program instructions, debugs routine programs, prepares system test data and prepares program documentation. Modifies, maintains and updates existing programs of a standard nature. Reviews potential application of programs to user need and assists in preparing feasibility studies to evaluate requirements for new and revised programs. Assists in the preparation of detailed systems design specifications to meet defined requirements. Prepares some basic block diagrams, flow charts, and associated documentation. Applies standard logic for individual applications programs and writes program instructions in a program language. Assists in the preparation of supporting procedures, forms and documentation. May identify and implement root cause fixes to program, system and/or applications errors. Qualifications Bachelor's Degree Computer Science or related discipline, or equivalent experience Req Two (2) years' experience in applications programming Req IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Job Overview Provide a wide range of medical surveillance support (including monitoring of clinical laboratory data for subjects in clinical studies and composing medical narratives and interfacing with investigator sites.) Essential Functions Monitor, and evaluate laboratory results on a daily basis from sponsor-designated central laboratory Evaluating and analyzing laboratory data at agreed frequency from sponsor-designated data management system/eDC platform Conduct preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using relevant clinical laboratory experience and compares current results with prior laboratory values to evaluate or note clinically significant increases/decreases and contacts the investigator site for pertinent additional clinical contact for distribution to project team Serve as liaison between the Medical Services Department and sponsor-designated laboratory and the IQVIA Project Team Maintain up-to-date laboratory knowledge via continuing education activities or attendance at medical seminars Based on clinical laboratory and monitoring experience, identify potentially significant trends or shifts in laboratory results and alerts IQVIA Medical Advisors Interact with project team to convey critical information that may impact study objectives Work with central laboratory staff to facilitate appropriate monitoring and reporting of subject laboratory results Assists Lead Medical Surveillance Specialist with project set-up activities Attends project team meetings, as needed Performs other related duties as assigned Qualifications Bachelor's Degree Life Sciences or allied health sciences,ie pharmacy,biochemistry, microbiology, biotechnology,nursing, biotechnology, medical laboratory sciences, physiotherapy health care ie medical (allopathy, homeopathy,ayurveda), or dentistry, 2 to 6 years relevant experience with a minimum 2.5 years of medical surveillance experience (req). r equivalent combination of education, training and experience. Strong technical ability to comprehend and integrate scientific data from a variety of sources. Strong communication skills, both written and verbal. Demonstrated computer skills, especially word processing and data management. Strong Analytical And Organizational Skills And Attention To Detail Required. Ability to establish and maintain effective working relationships with coworkers, managers and clients IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Job Overview Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective. Essential Functions Interprets the study protocol. Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable. Create and update Edit Specification Document. Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting. Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document. Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates. Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan. Escalate potential quality issues. Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures. Reviews build timelines and provide input as applicable. Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties. Responsible for multiple study design projects at the same time. Might be working on projects across multiple platforms. Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes. All responsibilities are essential job functions unless noted as nonessential (N). Qualifications Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req 2-4 years of relevant core Technical designer experience and total exp being 7+ yrs. Req IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Create end-user documentation which will include User Manuals, How to Do instructional manuals, Quick Reference Guides, Online Help. Format and check for English language usage when required. Collaborate with SMEs in various teams for knowledge transfer, for reviewing the created documents. Cross-functional support when needed. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.
Job Title / Primary Skill: Senior Java Developer Years of Experience: 4 to 7 years Job Location: Bangalore (Hybrid) Must Have Skills: Java Developer (JDK 8+) , Kafka, (Hive, MSSQL, Oracle, PostgreSQL, Azure Databricks). Educational Qualification: BE/BTech/ MTech/ MCA (Minimum bachelors degree) Key Responsibilities. Design, develop, and maintain Java-based microservices for data processing. Collaborate on data standardisation workflows and integrate AI/ML-driven enrichment features. Support workflow automation and role-based security for distributed systems. Write high-quality code, follow best practices, and participate in peer reviews. Develop and maintain unit, integration, and automated tests. Keep documentation for services and integrations clear and up to date. Take ownership of understanding business problems and designing effective solutions. Use AI-powered development tools to improve efficiency and code quality. Stay up to date with emerging AI trends and their impact on software engineering. Qualifications. Education. Bachelors or Masters degree in Computer Science, Information Technology, Software Engineering, or a related field. Experience. 5+ years of professional experience in software development, with a significant focus on Java. Experience with Spark and Kafka, or a strong willingness to learn. Hands-on experience with microservices architecture and cloud platforms (Azure preferred). Familiarity with Agile methodologies. Technical Skills. Mandatory. Strong proficiency in Java. Knowledge and experience with Kafka and Spark. Experience with containerisation tools such as Docker. Experience with CI/CD pipelines and DevOps practices. Proficient in version control systems such as Git (GitLab Ultimate). Nice to have. Proficiency with Postgres SQL / Hadoop Stack / Oracle. Experience with Scala / Python. Familiarity with application-level Elasticsearch implementation and querying. Experience with Snowflake / Databricks. Exposure to AI-driven data solutions and ML-based data enrichment. Familiarity with cloud platforms (Azure / AWS). Knowledge of role-based security models and workflow automation in distributed systems. Experience integrating heterogeneous data sources (Hive, MSSQL, Oracle, PostgreSQL, Azure Databricks). Understanding of search optimisation and performance tuning for large-scale data systems. Soft Skills. Demonstrated ability to work independently, proactively identifying and solving problems. Effective in agile environments and cross-functional teams. Strong problem-solving, analytical, and debugging abilities. Good communication skills for collaboration across distributed teams. Comfortable adapting to rapid changes in tools and workflows driven by AI and automation.
Job Title / Primary Skill: Manager Clin Data Mgmt Years of Experience: 12-16 Years Job Location: Kochi Must Have Skills: Clinical data management, data management, rave, Line management Good To Have Skills: Rave Job Description Manage and support team of Data Management professionals to efficiently produce databases that meet customer requirements. Essential Functions • Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency. Ensure that staff is trained and compliant with current operating procedures and work instructions and project scope of work. Identify and address professional development/training needs of staff. Mentor staff members to develop Data Management process, system, and drug development expertise. Provide operational input into proposals and scope of work. Participate in proposal defenses. • Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the team's utilization rates; the direct report's training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives. • Develop and implement plans for measuring and improving employee engagement, ensuring global consistency. • Collaborate with project leads to address work scheduling for current and projected projects, staffing needs, technological needs, and projected peak workloads, ensuring global consistency, where possible. Develop and manage associated action plans to hold members accountable. • Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership. • Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover. • Attend and participate in Bid Defenses, Kick off Meetings (KOM), as applicable. Support Request for Information (RFI), Request for Pricing (RFP), and budgets, as requested. • Participate / Support internal and external audits and inspections, as required. Also ensure required staff is assigned, trained and prepared to support. Professional Attributes Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Educational Qualification: Bachelor's Degree Clinical, biological or mathematical sciences, or related field Req • Equivalent combination of education, training and experience in lieu of degree.
Job Title / Primary Skill: Clinical DB Designer Years of Experience: 2-5 Years Job Location: Kochi/Kolkata/Bangalore/Hyderabad Must Have Skills: Clinical data management, rave, study startup activities, Edit Specification Documents, and EDC build specifications Good To Have Skills: Rave Job Description: • 2-5 years of relevant clinical DB Testing experience in CDMS Platforms • Conduct testing activities in CDMS environment and provide comprehensive testing expertise to the team to produce efficient, quality database that meets customer requirements. • Independently conduct testing activities to validate edit checks, system settings, SAS listings, Transfer Programming and custom reports in platforms including, InForm, RAVE, OCRDC. • Solid understanding of database structure. • Ensure validation processes and best practice guidelines are being followed strictly by self and team. • Solid understanding of documentation requirements and update all relevant documentation in a timely manner. • Communicate status of project to Validation Team Lead/Manager. • Escalate problems to the attention of Validation Team Lead/Manager. • Mentor Associate Validation Analysts in all testing activities. • Conduct Quality Reviews of testing projects on an ongoing basis as applicable. • Provide suggestions for continues process improvement and actively participate and contribute towards process improvement initiatives as assigned. • Understand and comply with core Operating Procedures and Work Instructions (including Best Practice and Guidance documents). • Meet project objectives as assigned by Validation Team Lead/Manager. • Develop and maintain good communications and working relationships with multiple teams across locations. Professional Attributes: Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Educational Qualification: • Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology .
Bengaluru, India | Full time | Hybrid | R1521247 Job Overview Responsible for study design, edit specifications and system configurations. The Clinical database designer is accountable for associated quality and timely delivery of assigned study design components in collaboration with other project stakeholders. Essential Functions Interprets the study protocol. Design and update the eCRF. Create and update Edit Specification Document. Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page) Complete the Study Authorization Form and Trial Capacity Request Form (InForm) Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document. Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates. Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan. Escalate potential quality issues. Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures. Reviews build timelines and provide input as applicable. All responsibilities are essential job functions unless noted as nonessential (N). Qualifications Bachelor's Degree Bachelor in Science/Computer science/Information Technology or Bachelor in Technology Req 0-2 years of relevant core Technical designer experience and total exp being 5+ yrs. Req IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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