43 Ctms Jobs

Dear candidate Hiring for Top MNC Client Notice: Immediate or 10 days Location: Bangalore We are looking for a person who has experience in Veeva Vault development not an end user Job Title: Veeva Vault Application Manager-Proficient Experience Level: 10+ yrs Job Description: Mandatory Skills: *Veeva Vault , *CTMS , Quality Docs, Promo mats, RIM, eTMF, *Clinical Operations, Research & Development. Extensive knowledge on managing Quality Processes such as Deviations, CAPA, Audits, change control and Investigations. Handling Veeva features Release and Project Release activities, Impact Assessments, analyze and plan appropriate actions on data remediation/data enrichment. Own and maintenance of business and technical documentation i.e. SOP's and work instructions as per compliance requirement. Troubleshoot and resolve issues with Vault connections to ensure seamless operation. Subject Matter Expert in CTMS Payment Module, handling data remediations, cleansing, and analysis, managing document template and deployment to higher environments. Perform Change management review and approvals for Business and Veeva release for core configuration and integration areas. Provide internal leadership and work with third party vendors in case of escalations Modelled management and organizational skills and multi-tasked and prioritized in deadline driven environment. For the Application Manager role, : Minimum 7 to 8 years of relevant experience Strong technical configuration knowledge and hands-on experience with Veeva Vault CTMS / RIMS / QualityDocs / QMS Functional knowledge or exposure to business processes in any of the above Vaults Proven experience in application management, including incident management and handling change requests Experience in release management and validating applications during releases Ability to manage stakeholder communication to assess and prioritize release features Understanding of GxP validation processes, documentation, and the software development lifecycle (SDLC) Application manager - Advance beginner: 4+ years of IT exp with at least 2+ years in Veeva vault Experience in Veeva vault - Clinical Operations, Quality, RIM Experience as Functional consultant - a profound knowledge of business processes in Commercial (incl. Medical Affairs) or/and R&D (Research & Development) Veeva vault certification (Platform, eTMF, RIM etc.) added advantage Application Manager - Competent: 6+ years of IT exp with at least 4+ years in Veeva vault Experience in Veeva vault - Clinical Operations, Quality, RIM Experience as Functional consultant - a profound knowledge of business processes in Commercial (incl. Medical Affairs) or/and R&D (Research & Development) Veeva vault certification (Platform, eTMF, RIM etc.) added advantage

You are an experienced Veeva Vault Clinical Engineer with a minimum of 5 years of experience, seeking a full-time position in Bengaluru, India with a hybrid work model of 2 days per week in the office. Your expertise lies in CTMS, eTMF, and CDMS (EDC) within the Veeva Vault ecosystem. In this role, you will be responsible for configuring, integrating, and supporting Veeva Vault Clinical applications to enhance clinical trial systems and ensure the smooth execution of clinical operations. Your key responsibilities will include configuring and supporting Veeva Vault Clinical applications such as CTMS, eTMF, and CDMS (EDC), as well as performing system integrations, connections, and enhancements within the Veeva Vault ecosystem. You will collaborate closely with cross-functional teams to support and enhance clinical trial systems. To excel in this role, you must possess a minimum of 5 years of experience working with Veeva Vault Clinical Suite, specifically CTMS, eTMF, and CDMS. Your strong hands-on experience in EDC build, configuration, integrations, and technical support will be crucial. Additionally, familiarity with clinical trial processes and their alignment with clinical systems is highly advantageous. You should be able to demonstrate both technical and functional expertise in Veeva Vault systems and exhibit excellent problem-solving, communication, and collaboration skills. Immediate to 30-day joiners are preferred for this position.,

At EY, you'll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture, and technology to become the best version of you. And we're counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. We are seeking a dynamic Manager to join our Life Sciences Consulting team, specializing in Clinical Operations transformation. This role involves working with global pharmaceutical, biotech, and medtech clients to optimize R&D and clinical delivery models, streamline operations, and implement emerging technologies across clinical development. Experience: 7-10 years Education: M.Tech / M.Sc / Ph.D. in Life Sciences, Biotechnology, Pharmacology, Clinical Research, or related disciplines Preferred Background: Life Sciences Consulting | Clinical R&D | Clinical Operations Strategy Key Responsibilities: - Lead and manage client engagements focused on clinical operations transformation, process improvement, and technology enablement. - Design operating models, workflows, and KPIs for clinical development functions. - Collaborate with cross-functional teams (regulatory, safety, data management) to align clinical strategies with enterprise goals. - Prepare business cases, PoVs, and transformation roadmaps for clients. - Support proposal development and go-to-market (GTM) strategies in the clinical domain. - Mentor junior consultants and contribute to knowledge building within the practice. Must-Have Skills: - Strong understanding of the clinical development lifecycle (from trial design through close-out). - Demonstrated experience in managing/leading consulting engagements. - Exposure to CRO management, site selection, clinical monitoring, or clinical project management. - Excellent communication, stakeholder management, and analytical skills. Nice-to-Have Skills: - Familiarity with technologies like SDTM, CDISC, CTMS, eTMF, or EDC systems. - Prior experience with clinical digital transformation initiatives (e.g., decentralized trials, risk-based monitoring). - Certifications in clinical project management or data standards (e.g., CCDM). EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people, and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform, and operate. Working across assurance, consulting, law, strategy, tax, and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.,

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS. ZS Life Science R&D Technologist in Clinical development ZS life science R&D team partners with client to discover and develop innovative medicines that improve patient's lives. Our work spans across consulting, analytics and technology (services and platforms) projects across the several domains. We have 3500+ zs professional that are delivering R&D programs, $100MM+ invested in R&D data, analytics and technology assets and 100+ clients on R&D programs. Our Clinical/Drug Development division displays a substantial history of contributing to numerous client projects with significant results in the drug development. The Drug Development R&D Technologists possess a deep understanding of technological solutions for clinical development processes including clinical study design, data management, analytics, and quality risk management platforms and products. They are well-versed in software related to clinical trial protocol design, electronic data capture (EDC), external data capture, data conformance, transformation, analysis, and reporting. Our team is well versed about industry standards such as CDISC, FHIR, OMOP, and their respective usage. Our team specializes in designing bespoke solutions or products implementation for clinical design, data management, and analytics systems. Our team has deep understanding of EDC tools like Rave, Veeva, InForm, openClinica, clinical data repositories like SAS LSAF, Oracle LSH, eCS elluminate, Metadata Repositories like Nurocor, Sycamore, Formedix, statistical computing environments like Sycamore, Domino, Sas Viya systems, Clinical data review systems, RBQM systems, and more. With experience as solution architects, business analysts, or techno-functional SMEs in GXP compliant validated environments, they guide the creation of solution, data flows and strategies for building clinical development and data management systems. Their offerings encompass technical advisory, consultancy, developing of clinical data platforms and products, system integration, and intelligent automation. Additionally, the team has created innovative tools through advanced technology and data science, aiding numerous clients in expediting the drug development process. What You'll Do You will spearhead the design & implementation of various innovative solutions in the realms of clinical trial, data management, analytics and RBQM. As a solution leader, your role will involve strategizing, offering tech consultancy, conducting assessments, and overseeing technology projects as the solution leader. You will be engaging with clients to review clinical business processes, determining requirements, establishing user narratives, and delivering solutions that have significant impact. You will lead requirements gathering activities and collaborate with product owner to prioritize and groom the backlog to ensure appropriate level of detail is captured at the right time You will lead team who review and Author high-level user stories and develop related tasks, acceptance criteria and review test cases Your team will work closely with project teams in creating requirement Specifications, requirement traceability metrics , user guides and other project requirement documents You will plan and facilitate various requirement gathering, solution meetings and artefacts You will work on creating process flows based on client and internal project discussions You will work to perform business process modelling, data flow, user experience modeling, and basic solution architecture diagramming Your team will act as techno-functional Liaison between client business user and project engineering team to provide correct business context, business rules You will work in building a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. What You'll Bring Bachelor's degree in engineering / Pharma/ Bioinformatics / Medicine or related disciplines Master's degree in business analyst, Engineering or Science preferred. 8+ years of experience working within Life Science Domain as solution architect / business analyst / data analyst is required. Experience of working in any of Clinical trial design, data management, analytics and RBQM system development, product implementation and Integration like EDC (Rave, Veeva, InForm), Non-EDC(ePRO, LAB,eCOA) , clinical data repository (CDR - SAS LSAF, Oracle LSH, eClinical elluminate ), Metadata Repository (MDR - Nurocor, Sycamore, Formedix) , statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is required. Strong verbal and written communication skills with ability to articulate results and issues to internal and client teams Experience in driving requirements discussions, workshops and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. Experience in building and delivering GxP compliant solutions for large enterprise program is required. Exposure to programming language like R, Python and SAS is preferred. Additional Skills Strong client presence and ability to communicate verbally and in writing complex domain concepts to all audiences. Significant supervisory, coaching and hands-on project management skills. Ability to manage a virtual global team environment that contributes to the overall timely delivery of multiple projects. Willingness to travel to other global offices as needed to work with client or other internal project teams. In-silico, digital twin, and/or modeling experience. Perks & Benefits: ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Travel: Travel is a requirement at ZS for client facing ZSers business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. Considering applying At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive. If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. To complete your application: Candidates must possess or be able to obtain work authorization for their intended country of employment.An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. Find Out More At:

As a SAP Fiori/UI5 Application Developer, you will be responsible for designing and implementing SAP Fiori/UI5 applications using SAPUI5, JavaScript, HTML5, and CSS3. Your primary focus will be to ensure the responsiveness and adherence to SAP Fiori UX guidelines in all applications developed. You will be required to customize and enhance SAP Standard Fiori Apps using Business Application Studio (BAS), SAP Web IDE, Adaptation, and Extension techniques. Leveraging Smart Controls, Annotations, and CDS-based metadata-driven UIs will be essential to efficiently build Fiori applications. Experience in developing apps in BTP with Side-by-Side Extensibility is crucial for this role. In addition, you will configure SAP Fiori Launchpad and Build Workzone by setting up and managing Fiori Launchpad Designer, configuring tiles, groups, Catalogs, and spaces, as well as integrating applications with SAP Build Workzone. Utilizing GitHub/GitLab for version control, automating deployment using CI/CD pipelines, and managing transports via CTS+ and Cloud Transport Management Service (CTMS) in SAP BTP will also be part of your responsibilities. An important aspect of the role will be to analyze and enhance application performance by implementing lazy loading, caching, and batch processing. You will also be expected to debug memory leaks and network latency issues to ensure optimal performance of Fiori applications. Ensuring security and role management will be a key part of your responsibilities. Working with SAP PFCG roles, handling OAuth & SAML authentication, and configuring secure access for Fiori apps in BTP and On-Premise environments will be crucial. Collaboration with SAP Functional, Basis, Security teams is essential to ensure seamless integration, deployment, and troubleshooting of SAP Fiori applications. While knowledge in ABAP & CAPM is considered good to have, a strong foundation in SAP Fiori/UI5 development and a proactive approach to problem-solving are essential for success in this role.,

Founded in 2004, MResult is a global digital solutions partner trusted by leading Fortune 500 companies in industries such as pharma & healthcare, retail, and BFSI. MResult's expertise in data and analytics, data engineering, machine learning, AI, and automation help companies streamline operations and unlock business value. As part of our team, you will collaborate with top minds in the industry to deliver cutting-edge solutions that solve real-world challenges. At MResult, you can leave your mark on projects at the world's most recognized brands, access opportunities to grow and upskill, and do your best work with the flexibility of hybrid work models. Great work is rewarded, and leaders are nurtured from within. Our values - Agility, Collaboration, Client Focus, Innovation, and Integrity - are woven into our culture, guiding every decision. In the role of Veeva Solution Architect, you will be a key contributor to MResult's mission of empowering our clients with data-driven insights and innovative digital solutions. Each day brings exciting challenges and growth opportunities. Your responsibilities will include but are not limited to: - Possessing 7+ years of experience in life sciences IT with hands-on expertise in Veeva Vault Clinical, CTMS, eTMF, Quality, RIM, or CRM. - Demonstrating strong technical expertise in Veeva configurations, workflow automation, APIs, and integrations. - Having familiarity with industry regulations like GxP, 21 CFR Part 11, GDPR, and HIPAA. - Ability to lead end-to-end Veeva implementations, including solutioning, configuration, testing, and deployment. - Demonstrating strong client-facing skills with the ability to translate business needs into scalable digital solutions. - Possessing Veeva Vault Administrator / Veeva Vault Configuration & Development certifications would be an advantage. MResult is an equal-opportunity employer committed to building an inclusive environment free of discrimination and harassment. Take the next step in your career with MResult where your ideas help shape the future.,

At Allucent, you will play a crucial role in helping small-medium biopharmaceutical companies navigate the world of clinical trials to deliver life-changing therapies to patients worldwide. As a Sr. Clinical Research Associate Contractor (Sr.CRA) on our remote A-team, you will have the opportunity to independently manage and monitor investigational sites, ensuring adherence to trial protocols, SOPs, regulations, and Good Clinical Practice standards. Your responsibilities will include maintaining the highest quality standards for trial monitoring activities, overseeing site activities to ensure protocol compliance, preparing detailed reports, updating CTMS systems, and providing support to the project team. You will also collaborate with stakeholders to track study progress, supervise data collection, and identify and address logistical challenges effectively. To excel in this role, you must have at least five years of clinical monitoring experience, a relevant life science degree or equivalent background, and a strong grasp of Good Clinical Practices and SOPs. Excellent communication skills, both written and verbal, proficiency in computer applications, and the ability to travel on-site as needed are essential. Your understanding of clinical trials, drug development processes, and medical terminology will be key to your success. At Allucent, we offer a comprehensive benefits package, competitive salaries, professional development opportunities, flexible working hours, and a supportive work environment that values growth and career progression. Join us to be part of a team dedicated to making a difference in the field of medical research. Please note that office-based employees are required to work in-office a minimum of two days per work week, with exceptions based on specific roles and locations. We do not accept unsolicited resumes from third-party recruiters and appreciate direct applications from interested candidates.,

• Implement and configure clinical trial solutions as per client requirements. • Collaborate with clients and internal teams for smooth project execution. • Provide training, documentation, and post-implementation support Required Candidate profile • 4+ years of IT solution implementation experience in Healthcare/Clinical Trials/Life Sciences. • Hands-on experience with CTMS, LIMS, EDC, or similar systems preferred. Perks and benefits - GPA &term Insurance-5 days week -Flexible timing

JOB DESCRIPTION Brief Position Description: The Application Specialist Senior - Veeva supports the day-to-day operations of Clinical Systems/ IT applications (with GxP categorization), ensuring optimal system performance and managing system enhancements. In addition, the Application Specialist (Senior) shall lead in resolving L2/L3 tickets and mentor/help Application Analysts for L1 ticket resolution for ensuring all defined KPI's and SLA's are met. The Application Specialist (Senior) provides training and technical support to clinical users, Application Analysts and contributes to the review and maintenance of processes, tools and standards. Minimum Qualifications & Experience: Degree in a related field computer science, information technology and/or information systems. Experience in clinical trial systems supporting the CRO and/or pharmaceutical industry is advantageous. Responsibilities: Provide L2/L3 support for clinical (CTMS, eTMF & Vault Safety) & IT systems with GxP categorization (e.g. LMS, BI application etc) as per company defined SLA's in different shifts to the users (internal and external) spread across different geographical regions (ANZ/Asia/Europe/USA). Manage user access and user roles for clinical (CTMS, eTMF & Vault Safety) & IT systems with GxP categorization (e.g. LMS, BI application etc) as per applicable Novotech IT SOP's. Responsible for clinical IT systems/applications training to all regions & Users and act as knowledge expert for the systems. Primary liaison with vendors and Novotech IT for maintenance changes and upgrades. Lead and deliver UAT testing for system upgrades, new release(s) and change management in collaboration with Clinical Systems, IT and business users. Set up of new projects/study, system specific templates/checklist, LOV's, workflows etc. Provide various reports from Clinical / IT Systems (with Gxp Categorization) in the form of data extracts from database (via SQL queries) as per study/ user requirements. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. ABOUT THE TEAM At Novotech we have advanced therapeutic and regulatory expertise, the ability to execute across markets and a client-centric service model,so that our clients get a trusted, long-term partner and an accelerated path to bring their life-changing advances to market. This gives our employees the opportunity to develop their careers by joining a diverse and supportive global organization with a collaborative culture, whilst working with clients on the cutting-edge of life sciences. At Novotech you will work alongside empowered teams with a shared commitment to success. Strategic vs transactional mindset. Ability to gain insights and make proactive decisions quickly. Culture that fosters partnership and collaboration, where every voice is heard and valued. Ongoing support from senior stakeholders and leadership team. .

Should have experience in clinical site payment. Should have experience in reconciliations and monitor clinical payment timelines. Review and interpret clinical trial agreements (CTAs) and budgets to set up payment terms and schedules. Process site payments accurately and on time based on study milestones and contract terms. Ensure payment activities are compliant with company policies, financial regulations, and contractual obligations. Maintain accurate tracking logs and documentation of payment status, outstanding payments, and accruals. Support monthly and quarterly financial reporting, accruals, and forecasting related to site payments. Utilize payment tracking tools/systems (e.g., CTMS, financial systems, Excel, Oracle, SAP). Contribute to the development and continuous improvement of payment processes and systems. Contact Person - Sangeetha Tamil Email - sangeetha@gojobs.biz

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 Requirements 10-12 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-party vendors 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 platforms like 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 Show more Show less

Key Responsibilities Standard Operating Procedures Adhere to all applicable Standard Operating Procedures (SOPs) and Work Instructions relevant to departmental and study-specific activities. Daily Operations Perform day-to-day operational tasks , ensuring adherence to quality standards and maintaining productivity levels. Metrics Tracking Track and report metrics as defined by management within required timelines. Process Improvement Participate in process improvement initiatives , assisting with the implementation of revised processes and procedures to enhance efficiency and compliance. Study Management Support Manage clinical systems and oversee access management for study tools and platforms. Handle and maintain study documents , supporting electronic Trial Master File (eTMF) management. Maintain and update study databases (e.g., CTMS , IWRS , EDC ). Assist the study team with data review and other support activities . Track and follow up with Clinical Research Associates (CRAs) regarding outstanding issues. Generate study-specific reports to support decision-making and monitoring. Manage internal and external communications to ensure alignment among stakeholders. Ensure training compliance for all study team members. Oversee study payments for clinical sites and vendors, ensuring accuracy and timeliness.

Study Leadership: Lead data management aspects of clinical trials, including studies involving healthy volunteers and patient populations. Ensure effective prioritization of workloads and adherence to deadlines. Project Delivery: Accountable for all Data Management deliverables, providing guidance to the DM study team to meet established timelines. Review study team outputs to ensure high quality and adjust resource allocations as necessary. Compliance Standards: Ensure that all allocated projects are executed in compliance with relevant protocols, global SOPs, and GCP standards. Timeline Management: Collaborate with Project Managers to develop timelines that align with contracted milestones, and actively manage project deliverables. Team Leadership: Provide leadership and accountability to the DM project team. Lead internal meetings, identify potential risks, and ensure proactive communication to achieve key milestones, such as database lock dates. Risk Mitigation: Work with cross-functional leads (e.g., EDC Design, SAS Programming, Statistics, PK) to identify risks and mitigation strategies that could impact timelines, resources, and deliverables. Client Relations: Build and maintain strong relationships with clients, review client satisfaction surveys, and address any concerns regarding project progress or deliverables. Scope Management: Track scope changes, ensure sponsor approval is obtained for any changes, and ensure accurate processing of scope adjustments. Mentorship: Provide mentorship and coaching to DM team members on clinical trial processes, data management practices, and career development. Technology Process Improvement: Stay updated on new data management technologies and industry trends. Implement process improvements to enhance operational efficiency at Fortrea. Database Reconciliation: Reconcile clinical databases with safety, laboratory, or third-party data to ensure data accuracy and completeness. Business Development: Represent DM in new business opportunities, promoting the capabilities of Fortrea s biometrics services to potential clients. Audit Compliance: Participate in audits and ensure that all audit findings are addressed within specified timelines. Qualifications:Education Experience: Required: University/College degree (or equivalent experience). Minimum of 6 to 8 years of experience in Data Management (DM), with at least 1 year in direct sponsor management. Familiarity with managing Scope of Work (SOW) and budgets. In-depth knowledge of clinical trial processes, DM, clinical operations, biometrics, and relevant system applications. Preferred: Experience in client relationship management and handling customer concerns. Knowledge of medical terminology and GCP. Skills Competencies: Leadership: Proven ability to lead and mentor teams, and collaborate across cross-functional departments. Project Management: Strong organizational and time management skills; ability to prioritize and adhere to deadlines. Communication: Excellent oral and written communication skills; effective at managing client interactions and internal team communications. Problem-Solving: Ability to identify risks, propose mitigations, and make data-driven decisions to ensure project success. Technical Proficiency: Proficient in clinical data management tools and technologies, with experience in database management, clinical trial management systems (CTMS), and relevant software

ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, our most valuable asset is our people. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers, and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning; bold ideas; courage and passion to drive life-changing impact to ZS. At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systemsthe ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are part of your success here. Learn more about our diversity, equity, and inclusion efforts and the networks ZS supports to assist our ZSers in cultivating community spaces, obtaining the resources they need to thrive, and sharing the messages they are passionate about. **What You'll Do** - Design & implement various innovative solutions in the realms of clinical trial, data management, analytics. - Work in designing a common data model based on clinical standards like SDTM / ADaM / ISS / ISE. - Design safety data mart for cross-study analysis and exploratory analysis. - Build analysis-ready datasets that serve various safety and exploratory use cases across clinical trials. - Experience in building use cases like safety signal detection, reverse translation research, combination therapy exploration. - As a solution lead, your role will involve planning, offering tech consultancy, conducting assessments, and executing technology projects. - Support leaders in engaging with clients to review clinical data models, determining requirements, establishing safety use cases, and delivering solutions that have a significant impact. - Lead requirements gathering activities and collaborate with the product owner to prioritize and groom the backlog to ensure an appropriate level of detail is captured at the right time. - Review and author high-level user stories and develop related tasks, acceptance criteria, and review test cases. - Work closely with project teams in creating requirement specifications, requirement traceability metrics, user guides, and other project requirement documents. - Plan and facilitate various requirement gathering, solution meetings, and artifacts. - Create process flows based on client and internal project discussions. - Perform business process modeling, data flow, user experience modeling, and basic solution architecture diagramming. - Build a Business Analysis capability, mentoring and upscaling more junior colleagues, and contributing to the growth of a BA community. **What You'll Bring** - Bachelor's degree in engineering / Pharma / Bioinformatics / Medicine or related disciplines. - Master's degree in business analyst, Engineering, or Science preferred. - Experience working within the Life Science Domain as a solution architect / business analyst / data analyst is required. - Experience of clinical data standards like CDISC (SDTM, ADaM), Safety data marts is required. - Experience of FHIR, HL7, USDM is preferred. - Experience of Data mapping and transformation in clinical data using various tools like TAMR, Oracle LSH, etc. - Experience of generating SDTM, ADaM datasets as part of statistical programming deliverables of clinical trials. - Experience of designing clinical data models as part of SDTM, ADaM, or safety data marts for submission or exploratory analysis. - Experience of building use cases like safety signal detection, reverse translation research, combination therapy exploration for exploratory analysis for clinical data of cross-study. - Experience of working in any of Clinical trial design, data management, analytics, product implementation, and Integration like EDC (Rave, Veeva, InForm), Non-EDC (ePRO, LAB, eCOA), clinical data repository (CDR, SAS LSAF, Oracle LSH, eClinical elluminate), Metadata Repository (MDR, Nurocor, Sycamore, Formedix), statistical computing environment (Domino, Sas Viya) system, CTMS, eTMF, CDMS is preferred. - Strong verbal and written communication skills with the ability to articulate results and issues to internal and client teams. - Experience in driving requirements discussions, workshops, and coordinating with internal and external stakeholders, across time zones, during the planning and delivery of technology projects is required. - Experience working in end-to-end Clinical Data Repository implementation with Biometrics space will be preferred. - Exposure to clinical data standards like CDISC (SDTM, ADaM), FHIR, HL7, USDM is required. - Experience in building and delivering GxP compliant solutions for large enterprise programs is required. - Exposure to programming languages like R, Python, and SAS is preferred. **Perks & Benefits** ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth, and professional development. Our robust skills development programs, multiple career progression options, and internal mobility paths and collaborative culture empower you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. **Travel** Travel is a requirement at ZS for client-facing ZSers; business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. **Considering applying ** At ZS, we're building a diverse and inclusive company where people bring their passions to inspire life-changing impact and deliver better outcomes for all. We are most interested in finding the best candidate for the job and recognize the value that candidates with all backgrounds, including non-traditional ones, bring. If you are interested in joining us, we encourage you to apply even if you don't meet 100% of the requirements listed above. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. **To Complete Your Application** Candidates must possess or be able to obtain work authorization for their intended country of employment. An online application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. **Find Out More At:** www.zs.com,

Medidata Rave CTMS/ETMF Job Summary: We are looking for a skilled Medidata CTMS/ETMF Product Consultant to support the implementation and use of Medidata CTMS/ETMF Key Responsibilities: Implement and support Medidata CTMS/ETMF. Perform configuration changes. Oversee master data creation and study setup. Manage user access, roles, and permissions. Perform data reconciliation and cleanup. Generate report dashboards in Visual Analytics. Troubleshoot user issues and submit enhancements. Ensure compliance with regulatory standards. Conduct user training sessions. Collaborate with cross-functional teams. Generate user training manuals. GXP change and validation management Qualifications: Bachelor's degree in Life Sciences, IT, or related field. 6+ years of relevant IT experience. Experience with Medidata CTMS/ETMF. Understanding of clinical trial processes. Strong problem-solving and communication skills.

The Application Specialist Senior - Veeva plays a key role in supporting the day-to-day operations of Clinical Systems/ IT applications with GxP categorization. Your responsibilities include ensuring optimal system performance, managing system enhancements, and resolving L2/L3 tickets. In addition, you will mentor Application Analysts for L1 ticket resolution to meet defined KPI's and SLA's. Providing training and technical support to clinical users and contributing to process review and maintenance are also part of your role. You should hold a degree in a related field such as computer science, information technology, or information systems. Experience in clinical trial systems supporting the CRO and/or pharmaceutical industry is advantageous. Your main responsibilities will involve providing L2/L3 support for clinical and IT systems, managing user access and roles, conducting training sessions for users, and liaising with vendors and Novotech IT for system maintenance and upgrades. You will lead UAT testing for system upgrades, set up new projects/studies, and provide various reports from Clinical / IT Systems through data extracts as required. At Novotech, we are committed to creating an inclusive work environment where everyone is treated fairly and with respect. We offer flexible working options, paid parental leave for both parents, wellness programs, and ongoing development opportunities to support our team members. We welcome individuals passionate about clinical research and biotech, including those who identify as LGBTIQ+, have a disability, or have caring responsibilities. As a Circle Back Initiative Employer, we commit to responding to every application and look forward to contacting you regarding your application.,

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.,