24 Ctms Jobs

As a Statistical Modeller - Clinical, you will be responsible for utilizing your expertise in clinical trials and clinical data monitoring to develop and implement statistical models. Your role will involve working with Bayesian and Frequentist models, as well as handling EDC, CTMS, ePro, and eCOA systems. You will also be involved in RBQM, signal detection, KRI analysis, and outlier detection. In this position, a strong understanding of GCP ICH E6/8 and EMA Guidelines is essential. Proficiency in statistical software such as SAS, R, JMP Clinical, and Python will be required for data analysis and modelling. Experience with visualization tools like Tableau and Power BI will also be beneficial. Additionally, familiarity with project management tools like Jira and Confluence is necessary to collaborate effectively with cross-functional teams. An advanced knowledge of R, HTML, and GitHub will further support your role in this dynamic environment.,

Job Description: You are invited to join our team at Eclat ISS as a Siebel Consultant on a contract basis. In this role, you will be responsible for working on-site in Hyderabad and managing various tasks associated with Siebel CRM implementation, customization, and support, particularly focusing on CTMS. Your primary responsibilities will include utilizing your expertise in Siebel CRM Implementation and Customization to ensure the successful execution of projects. Additionally, you will apply your knowledge of Siebel tools and technologies to provide ongoing support and address any issues that may arise. To excel in this role, you must possess strong problem-solving and analytical skills, which will be crucial in identifying and resolving challenges efficiently. Your ability to communicate effectively and collaborate with team members will also play a key role in your success. Ideally, you hold a Bachelor's degree in Computer Science, IT, or a related field, along with practical experience in Siebel CRM Support. If you are passionate about technology and eager to contribute your skills to a dynamic team, we encourage you to apply for this exciting opportunity. We look forward to welcoming a proactive and driven individual who is ready to make a valuable impact within our organization. Note: This is a summarized version of the job description and further details will be provided during the interview process.,

As the Manager, Clinical Operations at Kenvue, you will be responsible for coordinating the operational aspects of Higher complexity clinical studies for Consumer Health products in India, APAC, or EMEA. Your role will involve collaborating with key stakeholders within the Clinical Operations global organization, local India leadership, Study directors, Clinical IT, and Bioresearch Quality & compliance (BRQC). Your primary responsibilities will include leading operational aspects of clinical studies, ensuring compliance with ICH GCP guidelines, company SOPs, and local regulations. You will serve as the point of contact for local projects funded by India R&D, participate in pipeline planning, and mentor junior team members globally. Additionally, you will oversee the selection and evaluation of external service providers, train site personnel, identify quality risks, and develop corrective action plans as needed. Furthermore, you will be responsible for preparing or reviewing essential study documents, overseeing the preparation and release of investigational products, ensuring sponsor oversight, reporting adverse events, maintaining the Trial Master File, coordinating clinical trial disclosures, and writing/reviewing Clinical Study Reports. Your role will also involve providing administrative and technical support to junior Study Managers and aiding in site activation activities. To be successful in this role, you should possess a Bachelor's Degree in a scientific discipline or health care, with a minimum of 7 years of prior clinical study management experience, including at least 2 years in a people/team management capacity. You should have in-depth knowledge of global clinical research regulatory requirements, electronic trial master file management, and clinical trial management systems. Strong leadership, communication, organizational, and problem-solving skills are essential, along with proficiency in Microsoft Word, Excel, and PowerPoint. In return, Kenvue offers a competitive Total Rewards Package*, including paid company holidays, vacation, learning & development opportunities, and employee resource groups. The specific salary range and benefits will be discussed during the recruitment & hiring process. Join us at Kenvue in shaping the future and impacting the lives of millions of people every day through your work as a Manager, Clinical Operations in Bangalore, India.,

As a Solutions Engineer in the Pre-Sales team at ReleaseOwl, you will be a key contributor in supporting sales opportunities by effectively showcasing ReleaseOwl through engaging demos, creating Proof of Concepts (POCs), and aiding in pilot implementations. Your role will involve close collaboration with Sales, Product, and Engineering teams to deliver value-driven solutions and provide early-stage implementation guidance for successful handoffs. Additionally, you will be responsible for articulating the technical benefits of ReleaseOwl to both technical and business stakeholders, acting as a trusted advisor during pre-sales engagements and discovery sessions. To excel in this role, you should possess a minimum of 3 years of experience in SAP Basis or SAP landscape operations, with a strong background in Transport Management, cTMS, and Solution Manager (Solman). Hands-on expertise in SAP DevOps for BTP and SAP Integration Suite, familiarity with DevOps tools, CI/CD workflows, and SAP's transport architecture are essential. Excellent communication and presentation skills are required, along with the ability to simplify complex topics for varied audiences. Previous experience in pre-sales, customer-facing roles, or consulting would be advantageous. Joining ReleaseOwl will offer you the opportunity to work on cutting-edge SAP DevOps solutions that are shaping the future of enterprise automation. You will collaborate with a passionate team dedicated to building world-class SaaS products in a competitive compensation package and a global work environment. Moreover, there is potential for growth into solution architecture, product, or customer success roles within the company.,

In conjunction with the Submission Manager, and use of technologies, simplify the end-to-end process for Clinical Trial documents, maintenance and submissions Prepare Clinical Trial Submission documents adhering to regulatory guidelines and ensuring consistency across all BMS programs Partners with the Submission Manager for the timing and creation of the submission documents, including CSR appendices, Financial Disclosure Tables, and related submissions documents Ensures documents are formatted appropriately and Submission Ready Compliant (SRC) In collaboration with out outsourced partners, creates site numbers for new and ongoing clinical trials Enters site milestones and regulatory approvals dates to maintain the quality health of the trail assigned to Ensures Drug shipment address are entered correctly, and feed to SAP to enable IP Supply to sites Performs a reconciliation of Veeva (eTMF/CTMS) to ensure accurate data is available and reflecting correctly Proactively analyzes and drives efficient problem solving within team's control Applies critical thinking, developing mitigation and resolution strategies, and promptly responding to action items Demonstrates thorough knowledge of relevant BMS SOPs and policies and the ability to provide timely guidance in their application to Protocol and/or Program teams Assesses operational feasibility using GCPs, ICH and regulatory legislation and guidelines as they apply to submission deliverables where applicable Demonstrates strong project management skills Demonstrates thorough knowledge of creation of documents, and the document management systems and requirements (e g Core Template) Demonstrate understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process Manages interactions with senior level multifunctional teams across the oncology portfolio, to drive the operations submission documents Other duties as assigned to support Clinical Trials Performs other tasks as assigned Experience Requirements 2-4 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 Strong understanding of the pharmaceutical industry and of the non-clinical, clinical, business, ethical and regulatory components in the global drug development process

Role & responsibilities Lead end-to-end project management for IT/technology initiatives in the pharma/life sciences domain, ensuring timely delivery and within budget. Collaborate with cross-functional teams including R&D, Quality, Manufacturing, Regulatory, and Commercial teams. Define project scope, objectives, deliverables, milestones, and timelines. Manage vendor coordination, software implementation, system integration, and infrastructure deployments. Ensure alignment of projects with industry regulations such as GxP, CFR Part 11, HIPAA, GDPR, etc. Prepare detailed project plans, status reports, risk mitigation strategies, and issue logs. Act as a single point of contact for stakeholders, ensuring effective communication and expectation management. Facilitate change management, training, and adoption strategies. Ensure adherence to internal project governance, compliance, and validation procedures. Preferred candidate profile 1012 years of total experience in IT/Technology Project Management, with at least 5 years in the Pharma/Life Sciences domain. Proven experience managing technology transformation, digital health, lab systems (e.g., LIMS, ELN), clinical systems (e.g., CTMS), manufacturing systems or similar. Strong understanding of regulatory environments and compliance standards (FDA, GxP, CSV, etc.). Hands-on experience with Agile, Scrum, or Hybrid delivery methodologies. Ability to manage cross-functional teams and third-partyvendors. Excellent communication, stakeholder management, and leadership skills. PMP/Prince2/CSM certification is a plus Good To Have Experience with data platforms, analytics in pharma, or AI/ML initiatives in life sciences. Exposure to cloud migrations, enterprise platformslike SAP, Veeva, Oracle Health Sciences, etc. Prior experience with global project rollouts across geographies. Understanding of pharma manufacturing processes, quality control, or clinical development lifecycle

Dear Candidate, We are looking for someone with 68 years of experience in CRA, CTL, or CM roles for this position. This is an office-based job, and the location will be Ahmedabad. Working Days: Monday to Friday (Weekends off) Working Hours: 9 hours per day (Flexible timing) Role & responsibilities Responsible for end-to-end validation of CTMS and eTMF systems including system implementation, configuration change requests, periodic upgrades, Integration points with other systems (e.g., EDC) to improve the efficiency Perform periodic review and re-validation in accordance with system SOPs and sponsor-specific requirements. Conduct regular training sessions and refreshers on CTMS/eTMF systems for new hires and project teams. Provide the demo training of CTMS/eTMF systems to sponsor and internal stakeholders as applicable Responsible for user management onboarding, access provisioning, and periodic access review. Maintain access form for application user access and project specific access Develop and maintain study templates and configuration guides to standardize CTMS/eTMF use across projects. Maintain system-specific SOPs, work instructions, and validation documentation templates. Maintain and provide a support for user queries and issues. Liaise with vendor support and track resolutions for system bugs, performance issues, and configuration changes. Identify recurring operational inefficiencies and propose workflow improvements in CTMS and eTMF usage. Work with IT or software developer teams to develop auto-alerts/reminders, customize dashboards for operational oversight, data import/export but not limited too. Support vendor qualification processes for new CTMS/eTMF platforms or major upgrades as applicable. Monitor audit trail and metadata integrity within eTMF and CTMS. Ensure business continuity plans for system downtime, data recovery, and backup. Preferred candidate profile

Do you want to be part of an inclusive team that develops innovative therapies for patients At Astellas, we are dedicated to creating and delivering new medicines to patients and physicians. If you are excited about this work, you belong with us! Astellas Global Capability Centres (GCCs) are strategically positioned sites that provide Astellas with access to talent across various functions in the value chain and co-locate core capabilities that are currently dispersed. Our three GCCs are based in India, Poland, and Mexico. The GCCs play a crucial role in enhancing operational efficiency, resilience, and innovation potential, enabling us to respond promptly to evolving business demands. They are an integral part of Astellas, guided by shared values and behaviors, and are essential for the company's strategic priorities, sustainable growth, and commitment to transforming innovative science into value for patients. This hybrid position is located in Bangalore, India. We understand the significance of work/life balance at Astellas and are pleased to offer a hybrid working solution that allows you to connect with colleagues in the office while also providing the flexibility to work from home. We believe this approach will create the most productive work environment for all employees to excel and deliver. Hybrid work from specific locations may be permitted in accordance with Astellas Responsible Flexibility Guidelines. Purpose: This role is vital in ensuring the continuous delivery and development of analytics dashboards and solutions via the Qlik platform for Astellas" trial portfolio. The role aims to maintain the applications" continuity and understanding throughout the M&D business, ensuring timely utilization of data to enhance data integrity and trust. Responsibilities And Accountabilities: - Develop QLIK dashboards and data models, including maintenance, upgrades, integrations, and releases, and provide regular reports as per the schedule. - Manage day-to-day reporting needs, guide decision-making, and lead discussions. - Understand overall business requirements and provide systems, tools, and data to meet them, translating enhancements into project specifications when needed. - Follow an agile approach for software delivery and be familiar with applications in ADO, SQL, Python, SDLC. - Ensure that the functionality of the tool and data meets defined data governance standards accurately. - Manage and triage requests for new reports/visualizations and execute testing plans for system/tool improvement or implementation. - Collaborate to implement a streamlined suite of reports for decision-making. - Utilize pharmaceutical clinical drug development knowledge to anticipate changes needed to reports, metrics, analyses, and data models. - Oversee the quality review process to ensure changes in reports and data models align with agreed-upon approaches and information management governance standards. - Develop and maintain effective collaborations with key stakeholders, functions, and relevant external stakeholders. Required Qualifications: Education: - BA/BS degree. Experience: - Minimum 4-6 years in the pharmaceutical industry and/or management consulting group focused on R&D or clinical operations, with at least 2 years in a drug development setting. - Experience in using enterprise-wide data warehousing options and reporting tools/systems as a business user. - Strong knowledge of tools used in the pharmaceutical industry to support business operations data collection. - Demonstrated knowledge of global drug development processes and business procedures in clinical drug development. - Ability to work with stakeholders to define and understand requirements. - Excellent oral and written communication skills in English. - Experience in establishing standards supporting clinical and business operations systems. - Strong strategic thinker and problem solver with emotional intelligence. - Ability to build business relationships and influence without authority. - Ability to prioritize multiple projects efficiently. Preferred Qualifications: - Minimum 3-5 years of project management experience in a multicultural global setting. - Understanding of financial and resourcing planning systems/processes. - Ability to communicate effectively with functional leaders and negotiate solutions in a matrix environment. Working Environment: At Astellas, we value work/life balance and offer a hybrid working solution to optimize the most productive work environment for all employees. Hybrid work from certain locations may be permitted in line with Astellas Responsible Flexibility Guidelines. Category: Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.,

The Solutions Engineer - Pre-Sales at ReleaseOwl plays a pivotal role in the Pre-Sales team by demonstrating the capabilities of ReleaseOwl through engaging product demos, developing Proof of Concepts (POCs), and aiding in pilot implementations. As a Solutions Engineer, you will leverage your expertise in SAP Basis, Transport Management, and SAP BTP and Integration Suite DevOps practices to support sales opportunities effectively. Your responsibilities will include delivering tailored product demos that address customer pain points, creating and managing customer-specific POCs and pilot environments, collaborating with Sales, Product, and Engineering teams to craft value-driven solutions, providing early-stage implementation guidance, and communicating the technical advantages of ReleaseOwl to both technical and business stakeholders. Additionally, you will serve as a trusted advisor during pre-sales engagements and discovery sessions. To excel in this role, you should possess a minimum of 3 years of experience in SAP Basis or SAP landscape operations, a strong background in Transport Management, cTMS, Solution Manager (Solman), and hands-on proficiency in SAP DevOps for BTP and SAP Integration Suite. Familiarity with DevOps tools, CI/CD workflows, and SAP's transport architecture is crucial. Effective communication and presentation skills are essential, along with prior experience in pre-sales, customer-facing roles, or consulting, which is considered a strong advantage. By joining ReleaseOwl, you will have the opportunity to work on innovative SAP DevOps solutions that are reshaping enterprise automation. You will collaborate with a driven team focused on developing top-tier SaaS products and enjoy competitive compensation in a global work environment. Furthermore, this role offers the potential for growth into solution architecture, product, or customer success positions.,

Computer proficiency, Excellent knowledge in HACCP & GMP, working in freezers & chillers, staying late for night closing, with difficult customers, shift flexibility. Quality of all products, food safety. Training TMs & CTMs on food safety.

TCS has been a great pioneer in feeding the fire of young techies like you. We are global leaders in the technology arena and there's nothing that can stop us from growing together. TCS Hiring for skill " SAP BTP(Admin & Governance) ". Role: BTP Administrator Required Technical Skill Set: BTP Platform and Service Administration Experience: 5-8yr Work Location: Kolkata/Kochi/Bengaluru/Hyderabad Desired Competencies (Technical/Behavioral Competency) Must-Have: 1. Manage and maintain BTP platform, environments and services, including configuration, monitoring, and troubleshooting 2. Optimize BTP performance, scalability, and trouble shooting issues. 3. Integrate BTP with other SAP and non-SAP systems. 4. Experience with CTMS and transport management in SAP environments, CTMS and CTS+ integration, Experience with CI/CD tools (such as Jenkins, GitLab CI/CD, or Azure DevOps), Cloud ALM. 5. Minimum 2 to 3 yrs of experience handling BTP platform. Good-to-Have: 1. Certification in SAP BTP is a plus 2. Understanding of SAP BTP architecture, services, and feature. 3. Manage security measures to protect BTP environments and data. 4. Hands on experience on CF CLI and BTP CLI 5. Experience with cloud platforms, such as AWS or Azure. 6. Experience with DevOps practices and tools. Responsibility of / Expectations from the Role: Configure BTP platform to meet customer needs while providing best-practice guidance on customer processes. Hands on experience on the BTP services such as Integration suite, BAS, Workzone, CTMS, CICD and CALM. SAP and Non-SAP, On-prem and Cloud integrations with SAP BTP. Continuously upgrade self and customers with the latest updates in SAP BTP. Monitoring and scaling the BTP services based on the project/ customer demand.

TCS has been a great pioneer in feeding the fire of Young techies like you. We are global leaders in the technology arena and there's nothing that can stop us from growing together. TCS Hiring for skill ASPIRE - LSMV Consultants ( Aspire life science company created LSMV software (Life sphere Multivigilence)) We need Argus Developer who can work on LSMV software Role: Oracle Argus Developer Required Technical Skill Set: Argus LSMV ArisG Experience: 5+Yr Work Location: Kolkata & Delhi NCR Desired Competencies (Technical/Behavioral Competency) Must-Have: Develop and configure ArisG Life Sphere Multivigilance solutions to meet business requirements Customize and extend the functionality of the ArisG LifeSphere platform using APIs and SDKs. Collaborate with pharmacovigilance experts and stakeholders to understand user requirements and design appropriate solutions Implement data integrations with other systems such as electronic health records (EHR) and clinical trial management systems (CTMS) Design and implement workflows for case processing, signal detection, and regulatory reporting Perform system maintenance and troubleshooting to ensure the stability and performance of the ArisG Life Sphere platform. Provide technical support and training to end-users as needed. Proficiency in programming languages such as Java, JavaScript, or SQL. Experience working with the ArisG Life Sphere platform and its various modules (e.g., Mult vigilance, Signal Management, Aggregate Reporting) Familiarity with pharmacovigilance regulations and guidelines (e.g., FDA, EMA, ICH) • Strong analytical, interpersonal communication skills Good knowledge of SDLC / ITIL processes Ability to work effectively in a fast-paced environment and manage multiple projects simultaneously. Good-to-Have: Certification in ArisG Life Sphere administration or development Experience with other pharmacovigilance software platforms such as Oracle Argus or IBM PV. Knowledge of data analytics and visualization tools. Understanding of database design and management concepts. Familiarity with cloud computing platforms like AWS/Azure. Responsibility of / Expectations from the Role: 1. Designing and development and Migration activities 2. Handling tickets and change management activities 3. Daily interaction with customer and coordination between different team 4. Mentoring team

WorkSoft exp in automation script development Should have knowledge for making changes in worksoft scripts for conversion from SAP ECC to S/4 HANA, Should have knowledge of integration of Worksoft with other tools Script execution using WorkSoft Execution Manager or CTM , including batch execution SAP functional knowledge of at least one of process area ( SAP SD/SAP MM/ SAP FICO etc.) Exposure to testing in SAP landscape Good Communication skill Responsibilities would involve creating worksoft scripts, identifying test data needed, worksoft script execution, changes to worksoft scripts, uploading test results in test management tool, coordinating with different teams during script development, execution.

ECMS Req # 531129 Number of Openings 1 Duration of Hiring 1 year No of years experience 5+ years Detailed job description - Skill Set: Area of expertise: Veeva Vault Clinical CTMS & eTMF; Veeva Vault CDMS EDC Should have exposure and experience in Integrations, connections, configuration, Build, enhance, support experience. Functional knowledge of clinical trials and correlation with clinical systems is added advantage Should be able to demonstrate his technical and functional skills Hands on technical configuration experience Should have experience in configuring workflows and implement enhancements on their own Performed Veeva quarterly updates in the past Independent should lead the project on their own Should also have system support experience Location: Primarily at Bengaluru, India Mandatory Skills(ONLY 2 or 3) Veeva Quality Vendor Billing range in local currency (per day) INR 10,000/per day Work Location Bangalore Joining time ( Notice period) Immediate BGCHECK before or After onboarding After If its before-onboarding, please confirm whether final BG report is required or interim report is fine to onboard candidate Any Specific vendor to initiate BG No

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

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.

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

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

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

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

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.

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.

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.

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)