Clinical Systems Tester FCS Software Solutions

6.0 - 10.0 years

12 - 22 Lacs

Noida

Remote

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

Posted 12 hours ago

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IRT Validator Medpace Clinical Research India

2.0 - 6.0 years

4 - 9 Lacs

Navi Mumbai

Work from Office

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.

Posted 2 weeks ago

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