7 Oracle Inform Jobs

**Urgent Hiring for the Role of Python AI Engineer Automated Test Data Generation for our team** Title: Python AI Engineer Automated Test Data Generation Experience: 8+years Location : Remote Timing: US EST Hours Overview We are seeking a Python AI Engineer with expertise in synthetic and automated test data generation to support clinical trials, regulatory submissions, and GxP-compliant systems across the life sciences domain. This role will focus on building intelligent frameworks that generate high-quality, audit-ready datasets for use in clinical data management (CDM), biostatistics, pharmacovigilance, and regulatory validation environments. By leveraging AI/ML techniques and Python-based automation, this role will help reduce dependency on production data, accelerate testing cycles, and ensure compliance with stringent regulatory requirements (FDA, EMA, ICH E6, 21 CFR Part 11). Key Responsibilities Synthetic Test Data Automation Design and implement Python frameworks to automatically generate synthetic clinical and operational datasets. Create SDTM- and ADaM-compliant datasets for testing downstream workflows (data transformation, analysis, and reporting). Generate domain-specific datasets (e.g., adverse events, lab results, demographics, drug exposure) with variability, edge cases, and referential integrity. Develop connectors for Define-XML, Pinnacle21 validation, and statistical programming workflows. AI/ML Application in Data Generation Apply generative AI (LLMs, GANs, diffusion models) to simulate realistic clinical case scenarios. Build synthetic patient journeys for eCOA, EDC, CTMS, LIMS, or pharmacovigilance systems. Use AI-enabled automation to mimic rare or complex conditions for system stress testing. Compliance & Data Governance Ensure generated data adheres to GxP, 21 CFR Part 11, and HIPAA/GDPR requirements. Implement data anonymization/obfuscation while maintaining clinical and statistical relevance. Document all processes, including validation protocols, for audit and inspection readiness. Collaboration & Integration Partner with Clinical Data Management, Biostatistics, Pharmacovigilance, and Quality/Compliance teams to understand requirements. Integrate test data generation into CI/CD pipelines, clinical trial simulation frameworks, and automated validation environments. Support SMEs in assessing AI-generated datasets for plausibility and regulatory acceptability. Required Skills & Qualifications Strong proficiency in Python (pandas, NumPy, scikit-learn, PyTorch/TensorFlow, LangChain, etc.). Experience generating synthetic clinical trial data or working with CDISC standards (SDTM, ADaM, Define-XML). Familiarity with clinical data management systems (Medidata Rave, Veeva CDB, Oracle InForm, etc.) and testing needs. Understanding of GxP/21 CFR Part 11 compliance and regulated data handling. Knowledge of test automation frameworks (PyTest, Robot Framework) and data validation tools (e.g., Pinnacle21). Preferred Qualifications Experience supporting clinical trial systems (EDC, CTMS, PV, LIMS, eCOA). Understanding of statistical programming workflows (SAS, R) and integration with test data pipelines. Hands-on experience with cloud platforms (AWS, Azure, GCP) for secure AI/ML deployment. Familiarity with inspection readiness and validation documentation in a pharma context. Note: Interested candidates can drop their resumes at aagnihotri@fcsltd.com or dsingh15@fcsltd.com

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must Have Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc Project management skills: Managing the document development process and meeting timelines People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only) Location Gurgaon / Pune Educational Qualifications B.E. / B.Tech Computer Science-based courses or Circuit Branches M.Sc. / MCA in the stream of Computer Science B.Sc. / BCA in the stream of Computer Science

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must Have Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc Project management skills: Managing the document development process and meeting timelines People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only) Location Gurgaon / Pune Educational Qualifications B.E. / B.Tech Computer Science-based courses or Circuit Branches M.Sc. / MCA in the stream of Computer Science B.Sc. / BCA in the stream of Computer Science

Tools Required Rave Oracle Inform Veeva Studio Roles and Responsibilities Protocol reading and understanding Design the eCRF layout and the database corresponding to the eCRFs to hold the data from the EDC system Setup Core Configurations Implementing the Dynamic rules as per the Sponsor requirements Experienced in writing the Data Validation Specification (DVS) Create, test, and maintain trial-specific plausibility and consistency Edit Checks as per Data Validation Specification Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC Expertise in performing Technical and Functional Review Incorporate internal feedback and update programs as required Must Have Scientific background: A solid understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials Strong writing and communication skills: The ability to clearly articulate and concisely explain complex information Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP, etc Project management skills: Managing the document development process and meeting timelines People management skills: Managing the team of highly qualified individuals (applicable for Team Lead role only) Location Gurgaon / Pune Educational Qualifications B.E. / B.Tech Computer Science-based courses or Circuit Branches M.Sc. / MCA in the stream of Computer Science B.Sc. / BCA in the stream of Computer Science

As part of this role, you will be assisting in the development and implementation of solutions for global technical service issues related to EDC, SAS, or other proprietary software. Your responsibilities will include developing and validating Custom/Complex SDTM/SAS datasets, listings, and reports, as well as efficiently handling external data and data reconciliations. You will be responsible for configuring and implementing EDC services within assigned projects to ensure project integrity and on-time delivery of quality data. In addition, you will act as a technical liaison with project team members, clients, and Data Managers to drive the technical aspects of project delivery. You are expected to assist in leading EDC Builds and mentoring the study team in setting up software such as Medidata RAVE, Oracle InForm, SAS, or other proprietary software. Furthermore, you will lead the development of visual analytics dashboards using tools like Spotfire or Tableau. As a Subject Matter Expert (SME) and Lead on multiple projects, you will play a crucial role in developing proactive prevention strategies for technical service issues and concerns. Your role will also involve planning, managing, executing, and overseeing all SDTM programming activities across multiple studies. You will coordinate the activities of SDTM programmers across projects, provide technical expertise, and make statistical programming decisions/recommendations at the study or project level. Additionally, you will develop and validate Custom/Complex Edit-Check programs, reports, SDTM domains, and handle external data and data reconciliations efficiently. To ensure the successful delivery of projects, you will participate in lead/code reviews, meet with Data Managers to discuss technical strategies and timelines, and provide expert technical guidance to project teams. You will maintain awareness of new developments in EDC products/standards/tools and assist in developing and maintaining data loading procedures. Moreover, you will mentor and aid in staff development, oversee project work, and manage projects within assigned budgets. Qualifications: - University/college degree in life sciences, health sciences, information technology, or related subjects preferred. - Fluent in English, both written and verbal. - Relevant work experience of 6 to 9 years, including experience in data management, database programming, and specific software tools. Experience: - Demonstrated problem-solving skills and proactive approach. - Ability to lead teams, mentor staff, and communicate effectively. - Knowledge of clinical trial processes, data management, and systems applications. - Strong managerial and interpersonal skills. Physical Demands/Work Environment: - Office work environment. Please note that other duties may be assigned as needed.,

Job Role: Clinical Database Programmer Exp: 03-15 Years Location: Gurgaon, Pune, Bangalore, Hyderabad, Chennai, Kochi, Mumbai Tools Required: Rave, Oracle Inform, Veeva Studio (Any One) Mandate Skills: Research and analytical skills: Ability to gather, interpret, and synthesize data into insightful information. Attention to detail: Ensuring accuracy and adherence to guidelines such as Protocol, Specification, Library Standards, ICH GCP,etc. Looking for Clinical Database Programmer with a solid understanding of Clinical Protocol, Medical and Scientific Principles of conducting clinical trials. Analyze complex checks and Develop Custom Functions using C# for Rave studies or other EDC.

As a Clinical Database Programmer at ProcDNA, you will play a crucial role in designing the eCRF layout and corresponding database, implementing dynamic rules based on Sponsor requirements, and creating trial-specific Edit Checks. Your responsibilities will also include developing Custom Functions using C# for Rave studies or other EDC systems, incorporating internal and Sponsor feedback, and maintaining eCRFs and components as per protocol amendments or metadata updates. Additionally, you will support CRO trial activities, create reports using JReview, SAS, BOXI, and handle migration processes for Post Go-Live studies. To excel in this role, you must have a deep understanding of Clinical Protocol, medical and scientific principles of conducting clinical trials, and expertise in Critical Data Point Strategy (CDPS) or SDV implementation. Your strong writing, communication, research, and analytical skills will be essential in gathering, interpreting, and synthesizing data accurately. Attention to detail, project management capabilities, and the ability to manage a team are also crucial for success in this position. Ideally, you should be Certified in Medidata Study Builder (SDBE), Oracle - InForm/Central Designer, or Veeva Studio, with a background in Computer Science-based courses or Circuit Branches (B.E./B.Tech, M.Sc./MCA, B.Sc./BCA). Joining ProcDNA will offer you the opportunity to work in a fast-growing consulting firm that is making a real impact in the healthcare sector, collaborate directly with leadership, and contribute to shaping marketing strategies. Currently, we are seeking candidates for this role in Pune, Gurgaon, Bangalore, Kochi, Hyderabad, and Chennai. If you are passionate about database management, dynamic rules implementation, project management, and have a keen eye for detail, this role at ProcDNA could be the perfect fit for you. Apply now and be part of a team that values innovation, collaboration, and excellence in Commercial Analytics and Technology solutions.,