127 Ctms Jobs - Page 5

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...

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, w...

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,...

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 shou...

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 approv...

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 stakeholde...

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 f...

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 ...

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, pr...

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 s...

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 ...

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 developmen...

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 proje...

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 solutio...

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 product...

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 analyz...

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 & Responsibilitie...

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 withi...

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 ...

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 ...

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...

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 withi...

Primary Skills: 5+ years of experience in Veeva Vault Clinical (CTMS, eTMF, and/or Study Startup). 5+ years of experience in clinical trial processes and documentation workflows. 5+ years of experience in application support in GxP-regulated environments. 4+ years of experience in Vault Admin Console, security configuration, object lifecycle management. 4+ years of experience in managing support tickets using tools like ServiceNow, Jira, or Remedy. 4+ years of experience with validation (CSV or CSA) and change control procedures. 3+ years of experience managing or mentoring a small team or leading client interactions Role & responsibilities : Lead and manage the application support team for ...