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12.0 - 15.0 years

5 - 12 Lacs

Bengaluru / Bangalore, Karnataka, India

On-site

Foundit logo

Your role and responsibilities As a Solution Architect you'll be a pivotal team member who connects the client's technical functional and implementation requirements with a solution design and proposal. You'll work closely with clients and sellers to build solutions based on the meeting the client's business outcomes and known best practices for the technology and industry. In this fast-paced role, you'll design, and construct build work breakdown structure leading to the rough order of magnitude leading to the price and statement of work. A successful Solution Architect will demonstrate a natural bias towards self-motivation and navigating data and people to find answers and present solutions that ensure world class delivery. If you are passionate about success with both your career and solving clients business challenges, this role is for you. To help achieve this win-win outcome, a day-in-the-life of this opportunity may include, but not be limited to End-to-End Technical Guidance: Providing expert end-to-end technical guidance to lead discovery discussions with prospective clients, assess architecture needs for projects, work with technical leads and sellers to create proposals. Finding the Best Architectural Outcomes: Leading client workshops Required education Bachelor's Degree Preferred education Master's Degree Required technical and professional expertise 12 Years of SAP functional experience specializing in design and configuration of SAP APO modules - At least skill in 2 modules expected (e.g., DP+SNP, SNP+PPDS, DP+GATP etc.) Experience in gathering business requirements, providing conceptual and detailed designs to meet business needs, performing necessary SAP configurations, writing detail specifications for development of custom programs, testing, co-ordination of transports to production and post go live support The person should have least 2 end to end SAP implementation experience Should be able to create requirement specifications based on Architecture/Design/Detailing of Processes Also the candidate should have Min one Industry expertise preferably from CPG, Oil&Gas, Automotive, Retail, Pharma or equivalent Preferred technical and professional experience Proven work experience in GATP would be an added advantage Working knowledge of CIF, SNP Optimizer and CTM engine will be preferred For practitioner with APO DP skill should have working knowledge of BW

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8.0 - 13.0 years

10 - 15 Lacs

Pune

Work from Office

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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.

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9.0 - 13.0 years

27 - 42 Lacs

Chennai

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Job Summary The Sr Product Specialist (ISG) will play a crucial role in enhancing and managing our Veeva CTMS and Veeva systems within the Research and Development domain. With a hybrid work model and day shifts the candidate will collaborate with cross-functional teams to ensure seamless integration and functionality of these systems. This role requires a deep understanding of Veeva technologies and R&D processes to drive innovation and efficiency. Responsibilities Lead the implementation and optimization of Veeva CTMS and Veeva systems to support R&D activities. Oversee system configurations and ensure alignment with business requirements. Collaborate with stakeholders to gather and analyze system needs and translate them into technical specifications. Provide technical expertise and support to end-users ensuring smooth operation of Veeva systems. Develop and maintain documentation for system processes and configurations. Conduct regular system audits to ensure data integrity and compliance with industry standards. Coordinate with IT teams to troubleshoot and resolve system issues promptly. Facilitate training sessions for users to enhance their understanding and utilization of Veeva systems. Monitor system performance and implement improvements to enhance efficiency. Engage with vendors and external partners to stay updated on the latest Veeva technologies and best practices. Drive continuous improvement initiatives to optimize system functionality and user experience. Ensure compliance with regulatory requirements and company policies in all system-related activities. Support project management activities including planning execution and monitoring of system-related projects. Qualifications Possess a strong background in Veeva CTMS and Veeva systems with hands-on experience. Demonstrate expertise in Research and Development processes and requirements. Exhibit excellent problem-solving skills and the ability to work independently. Have a proven track record of managing and optimizing enterprise systems. Show proficiency in collaborating with cross-functional teams and stakeholders. Display strong communication skills to effectively convey technical information to non-technical audiences. Certifications Required Veeva Certified Administrator Veeva Vault Certification

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1.0 - 4.0 years

1 - 4 Lacs

Hyderabad / Secunderabad, Telangana, Telangana, India

On-site

Foundit logo

What you will do Let's do this. Let's change the world. In this vital role you will leverages domain, technical and business process expertise to provide exceptional end user support of Amgen's external suppliers to ensure their effectiveness to deliver Amgen clinical trials for Amgen study teams. This role involves working closely with internal and external business stakeholder and support analysts to ensure rapid resolution of technical issues, performing route cause analysis and implementation of long-term preventative solutions. You will collaborate with the Product Owner and a team of other Business Analysts to ensure operational support excellence from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Oversee expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and process problems and work with multi-functional owners to develop solutions Maintain accurate documentation of configurations, processes, and changes Maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Bachelor's degree and 0 to 3 years of Life Science/Biotechnology/Information Systems experience OR Diploma and 4 to 7 years of Life Science/Biotechnology/Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trials. E.g. Rave, CTMS, Veeva Excellent problem-solving skills and a committed attention to detail in finding solutions Good-to-Have Skills: Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum) Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career

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4.0 - 9.0 years

10 - 20 Lacs

Pune, Bangalore Rural, Mumbai (All Areas)

Work from Office

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Hi We're hiring for Leading ITES Company for EDC (Veeva Programmer) Role Experience in EDC & Veeva is Must. Job Description : Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,)) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit. Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. Adaptable to new ways of working using technology to accelerate clinical trial setup Education and Experience Requirements: Bachelor's degree or related experience. Knowledge of drug development process. Minimum of 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Experience programming in CQL, working with JSON format and/or C# is preferred Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 181 b) To Apply for above Job Role ( Pune ) Type : Job Code # 182 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 183

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2.0 - 7.0 years

11 - 20 Lacs

Indore, Pune, Ahmedabad

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Proficient in Veeva Vault EDC experience, CQL, CDB, working with JSON format and/or C#, CTMS, SAS, R or Python, Data Warehouses, SharePoint, Medidata Rave/ Oracle Inform. Required Candidate profile BACHELORS’ DEGREE IN A SCIENTIFIC / TECHNICAL DISCIPLINE Minimum 2+ years of experience in EDC programming International BPO experience is mandatory

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3 - 5 years

1 - 4 Lacs

Hyderabad

Work from Office

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Sr Associate IS Bus Sys Analyst What you will do Let’s do this. Let’s change the world. In this vital role you will leverages domain, technical and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans. This role involves working closely with business stakeholders, system owners and security analysts to ensure technical requirements are collated, documented and implement to ensure the success of our internal and external business partners. You will collaborate with the Product Owner and other Business Analysts to maintain an efficient and consistent process, ensuring the best quality deliverables from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Own expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and business problems and work with cross-functional owners to develop long-term solutions Maintain accurate documentation of configurations, processes, and changes Own technical solutions and maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree and 1 to 3 years of Life Science/Biotechnology/Information Systems experience OR Bachelor’s degree and 3 to 5 years of Life Science/Biotechnology/Information Systems experience OR Diploma and 7 to 9 years of Life Science/Biotechnology/Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trial. E.g. Rave, CTMS, Veeva Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum), Change management and problem management Excellent problem-solving skills and a committed attention to detail in finding solutions. Good-to-Have Skills: Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Skilled in providing oversight and mentoring team members. Excellent analytical and gap/fit assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career 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 and make a lasting impact with the Amgen team. 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.

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1 - 4 years

3 - 6 Lacs

Hyderabad

Work from Office

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Associate IS Bus Sys Analyst What you will do Let’s do this. Let’s change the world. In this vital role you will leverages domain, technical and business process expertise to provide exceptional end user support of Amgen’s external suppliers to ensure their effectiveness to deliver Amgen clinical trials for Amgen study teams. This role involves working closely with internal and external business stakeholder and support analysts to ensure rapid resolution of technical issues, performing route cause analysis and implementation of long-term preventative solutions. You will collaborate with the Product Owner and a team of other Business Analysts to ensure operational support excellence from the team. Roles & Responsibilities: Build strong relationship with key business leads and external partners to ensure their needs are being met Oversee expedited resolution of business-critical issues affecting the delivery of key external business partners Work with Product owner and business stakeholders to collected details requirements and user stories Analyze technical and process problems and work with multi-functional owners to develop solutions Maintain accurate documentation of configurations, processes, and changes Maintain detailed system and user documentation What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a with these qualifications. Basic Qualifications: Bachelor’s degree and 0 to 3 years of Life Science/Biotechnology/Information Systems experience OR Diploma and 4 to 7 years of Life Science/Biotechnology/Information Systems experience Preferred Qualifications: Must-Have Skills: Customer focused with excellent written and verbal communication skills who can confidently work with internal Amgen business stakeholders and external service partners on technology topics Experience of working with or supporting systems used to execute clinical trials. E.g. Rave, CTMS, Veeva Excellent problem-solving skills and a committed attention to detail in finding solutions Good-to-Have Skills: Experience of working with or in a Clinical Research Organizations (CROs) or other specialist suppliers supporting clinical trials Experience with Agile software development methodologies (Scrum) Knowledge of network security protocols and tools (e.g., IPSEC, SSL, IDS/IPS, firewalls) Experience of O365 Cloud PC VDI Professional Certifications : SAFe for Teams certification (preferred) Soft Skills: Highly organized and able to work under minimal supervision Excellent analytical and assessment skills Ability to work effectively with global, virtual teams Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Familiarity with GxP, CFR 21 Part 11 and systems validation Ambitious to further develop their skills and career 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 and make a lasting impact with the Amgen team. 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.

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5 - 10 years

10 - 15 Lacs

Bengaluru

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Job Title: Veeva Vault Clinical Engineer Experience: 5+ Years Location: Bengaluru, India (Hybrid 2 days/week in office) Note: Immediate to 30-day joiners preferred. About the Role: We are looking for an experienced Veeva Vault Clinical Engineer with a strong background in CTMS, eTMF, and CDMS (EDC) . The ideal candidate will have hands-on experience in Veeva Vault configuration, integration, and support activities. Youll work closely with cross-functional teams to support and enhance clinical trial systems, contributing to the smooth execution of clinical operations. Key Responsibilities: Configure and support Veeva Vault Clinical applications including CTMS , eTMF , and CDMS (EDC) . Perform system integrations, connections, and enhancements within the Veeva Vault ecosystem. Required Skills: Minimum 5 years of experience working with Veeva Vault Clinical Suite , particularly CTMS , eTMF , and CDMS . Strong hands-on experience in EDC build , configuration , integrations , and technical support . Familiarity with clinical trial processes and how they align with clinical systems is a strong advantage. Proven ability to demonstrate both technical and functional expertise in Veeva Vault systems. Excellent problem-solving, communication, and collaboration skills. Location: Bangalore, India – Hybrid model (2 days/week from office) Note: Immediate to 30-day joiners preferred.

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4 - 9 years

10 - 20 Lacs

Pune, Bangalore Rural, Mumbai (All Areas)

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Hi We're hiring for Leading ITES Company for EDC (Veeva Programmer) Role Experience in EDC & Veeva is Must. Job Description : Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,)) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit. Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. Adaptable to new ways of working using technology to accelerate clinical trial setup Education and Experience Requirements: Bachelor's degree or related experience. Knowledge of drug development process. Minimum of 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Experience programming in CQL, working with JSON format and/or C# is preferred Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : EDC Veeva & Inform Programmer Mumbai (Job Code # 181) b) For Position in Pune Search : EDC Veeva & Inform Programmer Pune (Job Code # 182) c) For Position in Bangalore Search : EDC Veeva & Inform Programmer Bangalore (Job Code # 183)

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4 - 9 years

10 - 20 Lacs

Pune, Bangalore Rural, Mumbai (All Areas)

Work from Office

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Hi We're hiring for Leading ITES Company for EDC (Veeva Programmer) Role Experience in EDC & Veeva is Must. Job Description : Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process Create edit check specifications and program or modify checks at study level within EDC Setup different instances of study URL (e.g.: UAT (User Acceptance Testing), production, testing etc.,)) Setup and configure user accounts for study teams Setup and manage blinded and unblinded study configurations Be the SME (Subject Matter Expert) for all database related activities Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Familiar with custom functions within EDC systems Work closely with EDC vendors regarding any tool related issues in the system Ability to troubleshoot database setup as per study needs Prepare, test and implement postproduction changes as per study needs Archive and retire the study URL after database lock Partner with appropriate team members to establish technology standards and governance models Establish and support business process SOPs. Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT (Information Technology), and Quality organizations Be a primary change agent to ensure adoption of new capabilities and business process Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality. Work with leaders to resolve issues affecting the delivery of clinical trials Collaborate with standards team in creating standard CRF libraries for study level consumption Work closely with data engineers and data management programmers at study level integration and delivery Lead technology vendor oversight activities. Be a process expert for operational and oversight models. Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks. Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit. Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. Adaptable to new ways of working using technology to accelerate clinical trial setup Education and Experience Requirements: Bachelor's degree or related experience. Knowledge of drug development process. Minimum of 4+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields. Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Experience programming in CQL, working with JSON format and/or C# is preferred Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint) To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : EDC Veeva & Inform Programmer Mumbai (Job Code # 181) b) For Position in Pune Search : EDC Veeva & Inform Programmer Pune (Job Code # 182) c) For Position in Bangalore Search : EDC Veeva & Inform Programmer Bangalore (Job Code # 183)

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2 - 5 years

5 - 12 Lacs

Hyderabad

Hybrid

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Role & responsibilities Provides entry level administrative support to assigned Project Manager(s), as well as site management for all assigned clinical trials. Administratively assists with all assigned project activities, ensures protocol adherence, and addresses non-compliance issues, as appropriate. Partners with clinical sites to coordinate and execute site activation procedures, personnel training, equipment credentialing, and query resolution. Looks for and identifies trends or issues with site activities and escalates appropriately. Ensures sites have adequate training and arranges ad hoc training(s) with the appropriate subject matter experts when necessary to ensure ongoing quality imaging and standardization. Responsible for updating CTMS with Site and Subject information accurately and in a timely manner. Pulls weekly reports and trackers from CTMS as requested. Responsible for maintaining Clinical Trial Records and performing scheduled assessments in a timely manner. Responsible for timely filing all project documentation and key correspondence for assigned trials. Responsible for study closeout record e-transfer transfer/shipments Assists PM with the coordination of internal, sponsor and other meetings, as needed and upon request. Creates study specific draft documentation, as well as weekly meeting agendas and minutes for PM. May provide administrative support during project-related audits. Assists with all other departmental requests as needed and upon request. Preferred candidate profile 2+ years administrative support experience, or similar, required. Clinical Trial experience or knowledge a plus Proficient in Microsoft Word, Excel, PowerPoint, and experience using database software Excellent organizational skills and attention to detail Strong written and verbal communication skills Proactive and ability to work independently. Flexible and able to manage multiple priorities and deadlines. Positive attitude, ability to work within a team environment. Perks and benefits Best in Industry

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3 - 6 years

3 - 6 Lacs

Dadra and Nagar Haveli, Chandigarh

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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

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