9 Irt Jobs

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. You will also be involved in Request for Proposals (RFPs) and present at Business Development (BD) Meetings. As a Senior Clinical Data Manager I, your key tasks will include: - Leading and serving as the primary contact for DM with all relevant parties internally and externally - Planning and projecting the resources required including management of tasks, timelines, risk, and quality - Developing, reviewing, and maintaining project-specific DM documents throughout the project lifecycle - Leading and coordinating the development of clinical study database set-up, eCRF design, and database validation requirements - Creating training materials for EDC users and providing project-specific training - Overseeing data cleaning strategy, data releases, data transfers, and reconciliation activities - Providing project metric reports, status updates, study progress, and feedback to the project team - Maintaining DM study documentation, supporting internal and external audits, and aligning data management and clinical programming best practices - Participating in client evaluations, preparing new proposals and budgets for Data Management services, and staying updated on regulatory development trends Requirements: - Life science, healthcare degree and/or combination of education and experience - Minimum 5 years of relevant work experience as a Clinical Data Manager - Thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and awareness of local/regional requirements - Experience with EDC software systems, IRT, eCOA, and CDISC conventions - Strong written and verbal communication skills, organizational, negotiating, and motivational skills - Ability to work in a fast-paced challenging environment and proficiency with computer applications Benefits of working at Allucent include: - Comprehensive benefits package - Competitive salaries - Departmental Study/Training Budget for professional development - Flexible working hours and remote/office-based working opportunities - Leadership and mentoring opportunities - Internal growth opportunities, employee referral program, and access to online training platforms *This position is for the Chennai Location and not home-based** *Please note that Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.*,

Job Description for the Current running requirement of Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT). Job Title: Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT) Experience: 6+ years Location: Remote 100% Work Timing: US EST time zone Job Description: - Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT) Overview: We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Key Responsibilities: Author and execute test scripts in Veeva EDC , aligned with protocol requirements Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools including handheld and remote-use devices Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior Review data capture logic and support query testing to ensure data accuracy Document test execution results, manage traceability, and support audit-readiness Contribute to ongoing improvements in test processes across DCT systems Required Experience: Strong, hands-on experience with Veeva CDMS (EDC) Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) Experience with IRT systems (e.g., Almac, 4G, Bioclinica) Prior involvement in DCT environments, including testing for remote or device-based workflows Understanding of clinical trial regulatory requirements (21 CFR Part 11, GxP) Detail-oriented with strong documentation and communication skills Share cv - vrani@fcsltd.com

Key Tasks & Responsibilities: The IRT Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinical study protocol with particular focus on the attributes of study drugs including comparators, medical devices, randomization and blinding. Ensures appropriate supply of study medication for all patients in a clinical trial by implementing optimal IRT supply strategies. The Manager continues to assume accountability of the IRT during the systems life cycle, implementing all required amendments. Leads the IRT cross-functional sub-team and is accountable for the set-up and maintenance of the IRT System with special attention to the proper and correct supply of study sites with study medication, including the correct drug dispensation according to the study protocol. Responsible for providing guidance and training to study teams. Qualifications & Competencies: Bachelors Degree or equivalent. Pharmacist degree preferred 5 to 8 years of relevant healthcare clinical development experience Profound knowledge in drug development Profound knowledge in setting up Interactive Response (IRT) Systems Profound knowledge in GCP and knowledge of GMP Excellent project management skills Excellent communication skills (including fluent English).

About Us Endpoint is an interactive response technology (IRT) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Raleigh-Durham, North Carolina with offices across the United States, Europe, and Asia. Position Overview The Senior Business Solutions Architect is responsible for the creation and management of the requirements and technical documentation for IRT projects. Senior Business Solutions Architects work closely with the client, Project Managers, and technical teams to ensure that each system is built and updated to meet the needs of the protocol. Responsibilities Collaborate with clients to define and document initial system requirements and enhancements needed for major changes to existing builds Act as subject matter expert on client clinical study protocol for studies with moderate to high complexity Author specifications for IRT, randomization and kit lists, and interfaces Build effective partnerships with other internal teams to move project through all phases of the development process. Support UAT setup and execution Understand the functional business process across the entire organization. Participate in and/or lead training and mentoring efforts of project team members in areas of identified expertise. Leads internal initiatives and projects that enhance delivery capability. Continuous learning on company platform and offerings as they evolve Education Bachelor's degree or equivalent preferred; appropriate experience in the IRT industry may substitute for the degree requirement. Experience 3-5 years experience in a software business analyst role, with a proven ability to understand technical concepts and learn very quickly. 2-4 years experience in the life science industry Previous experience working in a fast-paced, entrepreneurial environment preferred. Prior experience delivering voice (IVR) web (IWR) and mobile (IMR) platforms required. Familiarity using SQL a plus Skills Strong attention to detail and quality-focus Strong customer service orientation Excellent organizational and time management skills Good communication skills Excellent organizational skills Strong interpersonal skills with the ability to work effectively with a wide variety of professionals Solid written communication, including the ability to effectively document technical information Able to work on multiple assignments with limited supervision,

Key Tasks & Responsibilities: The IRT Project Manager assumes responsibility for operational execution of the IRT system used in clinical studies in development phases I to IV within clinical operations development operations The IRT is a critical system in ensuring safety of all patients taking investigational medicinal product (IMP,) and if not set-up correctly, could jeopardize the usability of data obtained within the clinical studies. As an expert in IRT, the Project Manager leads the set-up and testing of the system, ensuring it meets the requirements of the clinical study protocol and that all associated processes are fully compliant with GxP regulations. Revises / develops the clinical study protocol with particular focus on the attributes of study drugs including comparators, medical devices, randomization and blinding. Ensures appropriate supply of study medication for all patients in a clinical trial by implementing optimal IRT supply strategies. The Project Manager continues to assume accountability of the IRT during the systems life cycle, implementing all required amendments. Leads the IRT cross-functional sub-team and is accountable for the set-up and maintenance of the IRT System with special attention to the proper and correct supply of study sites with study medication, including the correct drug dispensation according to the study protocol. Responsible for providing guidance and training to study teams. Qualifications & Competencies: Bachelors Degree or equivalent. Pharmacist degree preferred 5 to 8 years of relevant healthcare clinical development experience Profound knowledge in drug development Profound knowledge in setting up Interactive Response (IRT) Systems Profound knowledge in GCP and knowledge of GMP Excellent project management skills Excellent communication skills (including fluent English)

**Urgent Hiring for the Role of Clinical Systems Specialist Veeva CDMS for our Team** Job Title: Clinical Systems Specialist Veeva CDMS Experience: 8+ years Location: Remote 100% Work Timing: US EST time zone Job Description: - Job Title: Clinical Systems Specialist Veeva CDMS Overview: We are looking for a skilled Clinical Systems Specialist with strong, hands-on experience in Veeva CDMS (EDC) . This role focuses on testing and validation within the Veeva environment and supports various modules in the Veeva CDMS suite. While deep experience with eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms is not required, you should understand how they work within decentralized clinical trials (DCTs) and be comfortable working alongside these systems. Key Responsibilities: Validate workflows within the Veeva EDC module and related components. Apply working knowledge of eCOA and IRT systems to understand clinical data flows and dependencies. Collaborate with clinical operations, data management, and vendors to troubleshoot issues and ensure systems meet requirements. Review data capture logic and perform query testing to maintain data accuracy. Document test results, maintain traceability, and ensure audit-readiness. Help improve validation processes and documentation within the Veeva CDMS environment. Required Qualifications: Strong, hands-on experience with Veeva CDMS , especially the EDC module. Familiarity with eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) and IRT systems (e.g., Almac, 4G, Bioclinica) is a plus. Experience working in decentralized clinical trial (DCT) environments is highly desirable. Solid understanding of regulatory requirements ( 21 CFR Part 11 , GxP ) for clinical systems. Excellent attention to detail with strong documentation and communication skills. Ability to work effectively in cross-functional teams and with external vendors. Note: Interested candidates can drop their resumes at aagnihotri@fcsltd.com

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

Position: Clinical Systems Tester Veeva CDMS / Decentralized Clinical Trials (DCT) Overview: We are looking for a well-rounded Clinical Systems Tester with core expertise in Veeva CDMS (EDC) and strong hands-on experience with eCOA and IRT platforms. This role supports testing and validation activities within a Decentralized Clinical Trial (DCT) environment, requiring flexibility across various digital systems and patient-facing technologies. Job Description: Key Responsibilities: Author and execute test scripts in Veeva EDC, aligned with protocol requirements Validate workflows across eCOA (electronic Clinical Outcome Assessments) and IRT (Interactive Response Technology) platforms Participate in system validation (IQ/OQ/PQ, UAT) for DCT tools including handheld and remote-use devices Collaborate with clinical ops, data management, and vendors to troubleshoot issues and verify system behavior Review data capture logic and support query testing to ensure data accuracy Document test execution results, manage traceability, and support audit-readiness Contribute to ongoing improvements in test processes across DCT systems Required Experience: Strong, hands-on experience with Veeva CDMS (EDC) Working knowledge of eCOA platforms (e.g., Medidata, YPrime, Clinical Ink) Experience with IRT systems (e.g., Almac, 4G, Bioclinica) Prior involvement in DCT environments, including testing for remote or device-based workflows Understanding of clinical trial regulatory requirements (21 CFR Part 11, GxP) Detail-oriented with strong documentation and communication skills. Interested Candidate Can apply : dsingh15@fcsltd.com

Title Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based IRT Validator to join our Randomization and Study Product Management team in Mumbai, India. This position plays a key role in the clinical trial management process at Medpace. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Creation of test plans; Execution of test plans and creation of validation packages; Review of validation packages created by other team members; Review requirement specification documents provided by internal clients; Validation of new projects and changes to existing projects; Qualifications Bachelor’s degree in Math, Computer Science, or related field required; Demonstrated ability to complete validation tasks within defined time frames and to appropriate quality levels; Fluent in English. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.