4 Irt Systems Jobs

As an Implementation Consultant reporting to the Product Owner, your key responsibilities will include creating User Requirement Specifications (URS) and functional requirement specs in Clinical Reporting and Analytics. You will be tasked with developing wireframes and mock-ups for clinical reports, as well as communicating with Clinical Data Management & Medical Reviewers to document clinical reporting needs. It is essential that you stay up-to-date with all Saama product features and releases. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will act as a Clinical Subject Matter Expert, providing support for Clinical Project Support, authoring and documenting business requirements, and translating requirements into solutions. Additionally, you will create and maintain Data Mapping Specifications for the Saama Data Review Model. You will collaborate with customers, partners, and in-house teams to gather feedback and input on the product. As an Implementation Consultant, you will guide clients through release planning, manage communication with the team and stakeholders, lead product implementation efforts, and ensure the quality of project team deliverables. You will document and report project status and issues, identify and manage risks, and act as a client liaison to resolve outstanding issues promptly. Your responsibilities will also include ensuring a smooth transition of services from implementation to support, providing advanced analytical and reporting support to customers on various projects, and supporting configuration and quality checks with project teams. You will help identify and define new sources of relevant data, analyze data, and make recommendations. Desired skills for this role include experience in the Pharmaceutical industry, a good understanding of EDC, CTMS, IRT, and LAB Systems, proficiency in SQL, familiarity with CDASH, SDTM, and ADAM standards, and relevant degrees in Healthcare, Computer Science, or related fields. Additionally, experience as a Product Owner, familiarity with Agile Working Environment, SDLC phases, FDA regulations, and technical knowledge of Software Development and Web Development are preferred qualifications for this position.,

As an Implementation Consultant, you will be responsible for managing and assuming accountability for all aspects of projects related to implementation. Your key responsibilities will include guiding the client through release planning, managing communication throughout the team and stakeholders, leading product implementation efforts, coordinating with customers, product SME, and other teams, managing the quality of implementation deliverables, and documenting and reporting status on Risks, Issues, Actions, and Decisions. You will need to identify, report, and manage risks while overcoming project obstacles. Acting as a client liaison and representative, you will communicate client feedback to appropriate representatives and act to resolve outstanding issues on behalf of the client in a timely manner. Understanding the client's clinical landscape, you will provide techno-functional solutions to evolving client needs. Your role will involve analyzing and understanding current business processes, events, and flows in Clinical Trial Development. You will create SOPs and Work instructions for the implementation/delivery team to ensure a smooth transition of services from implementation to support. Additionally, you should be able to incorporate feedback and input from customers, partners, and in-house teams on product features. Desired Skills: - Experience in the Lifesciences and Pharmaceutical industry is essential - Good experience in SQL, APIs, and Integrations - Good understanding of CDASH, SDTM, and ADAM standards - Good understanding of EDC Systems, CTMS Systems, IRT Systems, and LAB Systems - Knowledge of clinical trial domain, EDC study setup, and clinical reporting - Ability to build clinical reports and dashboards - Relevant degrees such as Bachelor's and Master's Degree in Healthcare, Computer Science, Technical, Engineering, Computer, Computer Engineering, Computer Programming - 3-5 years of experience as a Product Manager or 1-2 years of experience as a Product Owner - Comfortable and familiar with the Agile Working Environment - Experience working with all phases of SDLC - Familiarity with FDA regulations such as 21 CFR Part 11 and GxP is a bonus - Experience working in the complete product life cycle of two or more products - Technical knowledge including Software Development and Web Development - Experience with the use and configuration of healthcare software applications (preferably clinical),

Summary 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

Job purpose : The Clinical Database Programmer is a key member of Clinical Biometrics team. This individual will be responsible for providing database services including database design, creation, and validation to collect data for research, development, and/or marketed product. The individual should be able to ensure accurate data collection from electronic systems through error-free programming. This individual will work closely with the Biostatistics and Data Management team as well as other Ocugen team members to execute the statistical and data needs of the clinical studies. Duties and responsibilities : Collaborates with other team members to define database requirements . Involves in programming, validation of standard and study-specific electronic Case Report Forms (eCRFs). Troubleshoots and resolves database issues timely. Designs, implements and maintaining databases or collaborates on implementation and collection of data supporting research protocols. Provides database consultation for research programs. Collaborates on development of database specifications, data management plans, data transfer specifications, data review specifications and/or data quality review plan specifications Develops edit checks, QC, and validation reports to ensure quality data. Provides input to project timelines and ensures that project timelines for database deliverables are met. Ensures that project tasks are completed with acceptable quality. Ensuring data integrity ,security and availability. Perform database back ups and recovery. Attends team meetings. Additional tasks and projects as requested. Qualifications: BS/BA degree in Computer Science, or work-related experience. 5-8 years related experience. Experience with relational databases and Programming. Experience with developing eDC databases (e.g. Veeva Vault or RAVE), IRT systems (including randomization), and ePRO applications for data collection. Database programming language experience (e.g. SQL, PHP). Website programming language experience is a plus (e.g. HTML, Javascript) Statistical programming language experience is a plus (e.g. SAS, R, Python). Working knowledge of GCPs, ICH, FDA, and CDISC regulatory requirements governing clinical studies. Demonstrated attention to detail and outstanding organization skills. Self-motivated with a commitment to high quality, on-time deliverables. Working conditions: This position operates in an office and/or remote setting. Job may additionally require incumbent to be available outside of regular 9-5 hours to handle priority business needs. Physical requirements: This is a largely sedentary role.