86 Ctms Jobs - Page 3

• 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 ...

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...

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 communi...

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 platfo...

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...

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 i...

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'...

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 t...

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...