Validation Protocols Jobs in Thane

Associate Clinical Data Base Validation Manager Location: Thane Job Overview: The Associate Clinical Data Base Validation Manager will lead testing activities to ensure high-quality databases that meet customer requirements and regulatory standards. This role involves overseeing project planning, execution, and close-out phases, managing financial aspects, communication, and milestone deliverables while ensuring compliance with Good Clinical Practices (GCP), applicable regulatory guidelines, and internal SOPs. Key Responsibilities: Project Management & Planning: Attend Kick-Off meetings and regular project meetings until Study Go Live. Take full responsibility for creating the Edit Checks Test Plan document and writing test cases. Review the Project Plan, escalating any issues to stakeholders. Testing & Validation: Release the Edit Checks Test Plan to the testing team and manage testing activities. Perform eCRF and Time & Events QC as per QC checklist. Review and escalate issues related to ASB and Edit Specification documents. Test email alerts and document changes in version history. Validate system configuration, including AUL, Rights and Roles, Home page, and System Settings. Provide project status updates on validation activities to the Data Team Lead and Lead Programmers. Documentation & Reporting: Document all testing documentation in eDMSF in a timely manner. Maintain clear communication with internal customers and stakeholders. Review Testing Comments Log after each testing cycle and share it with programmers. Ensure accurate and timely documentation of all validation processes. Team Leadership & Coordination: Coordinate with internal teams and ensure resources are assigned appropriately to meet project deliverables. Train and mentor Testing Team Members, providing leadership in validation processes. Implement proactive quality management plans and identify root causes of issues for remediation. Lead the team in driving changes across projects to improve processes and ensure compliance. Quality & Financial Management: Review the QIP for appropriate budget allocation and communicate out-of-scope activities. Supervise implementation of new technology. Review individual project financial performance and communicate issues to stakeholders. Ensure adherence to study budgets. Customer Relationships: Serve as the primary point of contact for internal customers regarding testing deliverables. Develop and maintain strong customer relationships and provide negotiation support for timelines, financials, and resources. Qualifications: Education: Bachelor s degree in Science, Computer Science, Information Technology, or Bachelor in Technology. Experience: 4-6 years of relevant clinical database testing experience in Clinical Data Management Systems (CDMS) platforms. A total of 6+ years of relevant experience. Skills & Competencies: Strong project management and leadership skills. Deep understanding of clinical data validation, testing processes, and database management. Ability to work cross-functionally and manage multiple projects simultaneously. Proficiency in MS Office, database management, and eDMSF systems. Strong communication and interpersonal skills for working with internal and external stakeholders. Desired Attributes: Attention to Detail: Ability to meticulously track and validate database changes and project status. Problem-Solving Skills: Strong analytical skills to resolve complex testing and validation issues. Team Leadership: Proven experience in managing and mentoring a testing team, ensuring the quality and consistency of deliverables. Customer-Focused: Strong customer relationship skills to manage and exceed client expectations effectively. This role offers an excellent opportunity for an experienced Clinical Data Base Validation Manager to drive successful clinical data management processes and enhance operational quality within a dynamic team. If you are a motivated professional with a strong background in clinical data validation and testing, we encourage you to apply. Qualification : Bachelors degree in Science, Computer Science, Information Technology, or Bachelor in Technology.

Job Title: Statistical Programmer Key Responsibilities: Develop SAS programs to generate derived analysis datasets and produce content for tables, listings, and figures (TLFs). Validate programming outputs to ensure the quality and accuracy of analysis datasets. Provide programming support to project teams by developing programming strategies, standards, specifications, and executing programmed analysis. Assist in the preparation and review of electronic submissions. Review key planning documents (e.g., statistical analysis plan, data presentation plan, data review plan) to ensure alignment with project objectives and clarity in programming assumptions and requirements. Assess the impact of these documents on programming tasks. Collaborate with vendors to establish project standards, programming conventions, and manage programming specifications and file transfers. Lead the effort to ensure the quality of Global Biometric and Data Sciences (GBDS) deliverables, applying standards consistently and adhering to regulatory guidelines, corporate SOPs, and departmental work practices. Identify opportunities for enhancing efficiency and consistency within GBDS and improve interactions with strategic vendors. Independently manage and perform programming tasks with minimal supervision. Contribute to continuous improvement initiatives to optimize workflows and outputs. Minimum Qualifications: Bachelor s degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field. At least 3 years of programming experience in a relevant industry. For US-based positions, US military experience will be considered as part of industry experience. Proficiency in using SAS, R, or other programming languages to create derived analysis datasets and TFLs. Strong understanding of clinical data structures (e.g., CDISC standards) and relational databases. Proficiency in software tools such as MS Office and XML. Experience in handling and processing upstream clinical data (e.g., multiple data forms, eDC, SDTM). Ability to produce outputs that meet downstream requirements (e.g., ADaM, Data Definition Table, e-submission). In-depth knowledge of regulatory, industry, and technology standards and requirements. Familiarity with statistical terminology, clinical tests, medical terminology, and protocol designs. Demonstrated ability to collaborate within a team environment alongside clinical team members. Preferred Qualifications: A minimum of 3 years of experience in clinical/statistical programming within pharmaceutical clinical development. Knowledge of the drug development process, clinical trial methodology, and familiarity with global regulatory requirements. Experience using other software packages (e.g., R). Familiarity with the Linux operating system. Qualification : Bachelors degree in Statistics, Biostatistics, Mathematics, Computer Science, Life Sciences, or a related field.

Key Responsibilities: 1. Customer Communication & Support: Possess excellent communication skills to handle customer inquiries and resolve issues effectively. Show empathy and patience to calm irate customers, ensuring a positive customer experience. Respond to incoming calls and customer emails in a timely and professional manner. 2. Technical Troubleshooting: Troubleshoot and resolve issues related to the base operating system, Windows, Outlook, Teams, Citrix, VDI, VPN, Security Apps, and other related technologies. Provide remote support to diagnose and resolve technical issues. Stay eager to learn and adapt to new technologies as required for customer support. 3. Issue Resolution: Manage and resolve customer complaints, ensuring all concerns are addressed promptly and thoroughly. Research and offer solutions to customers using available resources and technical tools. Identify patterns or recurring issues and escalate to supervisors when necessary. Route customer calls and tickets to the appropriate teams or resources for specialized support. 4. Documentation & Reporting: Document all customer interactions and technical troubleshooting steps as per standard operating procedures (SOPs). Create and update SOPs for newly encountered issues and resolutions provided to customers. Complete call logs and provide reports detailing the nature of customer concerns and resolutions. 5. Trend Identification & Process Improvement: Recognize, document, and alert management of any recurring trends in customer calls or issues. Contribute to process improvements by suggesting solutions for recurring problems or inefficiencies. Skills & Competencies: Communication Skills: Strong ability to communicate technical issues and solutions effectively to customers. Problem Solving: Ability to troubleshoot and resolve various technical issues quickly and accurately. Technical Knowledge: Solid understanding of Windows, Outlook, Teams, Citrix, VDI, VPN, and security applications. Customer Focus: Ability to empathize with customers, especially when handling irate or frustrated customers. Documentation & Reporting: Proficiency in maintaining accurate records of calls, issues, and resolutions. Teamwork & Escalation: Collaborative in routing calls and issues to the appropriate departments when necessary.

Senior DIU Executive Experience: 6 8 Years | Location: Thane Job Overview The Senior DIU Executive (MIS / Data Analytics) is responsible for managing, analyzing, and presenting organizational data to support informed decision-making. This role ensures data accuracy, consistency, and quality while identifying trends and insights that impact business performance. The position works closely with cross-functional teams to improve systems and data governance strategies. Key Responsibilities Cleanse, validate, and correct data by identifying corrupted records, coding errors, and inconsistencies. Develop and maintain data systems, ensuring information is organized in a structured and readable format. Apply statistical techniques to analyze complex datasets for diagnostics and forecasting. Assign measurable metrics to key business functions to evaluate and compare performance over time. Prepare and present detailed analytical reports highlighting insights, patterns, and predictions for management. Collaborate with programmers and leadership to recommend system enhancements and reporting standards. Conduct Exploratory Data Analysis (EDA) to identify patterns and summarize data characteristics. Required Skills & Competencies Advanced proficiency in MS Excel and Power BI. Expertise in data cleansing, preparation, validation, and visualization. Strong critical-thinking skills with a structured, logical approach. Excellent verbal and written presentation skills with the ability to manage stakeholder relationships. Ability to analyze local and global trends affecting the industry.

Tech Services Engineer Department: R&D EMACS Location: Thane Job Purpose The Tech Services Engineer is responsible for developing, testing, and maintaining firmware for microcontroller-based embedded systems. This role requires hands-on expertise in C programming and low-level driver development to ensure reliable system performance through hardware-software collaboration. Key Responsibilities Firmware Development: Develop, implement, and maintain embedded system firmware using C language. Microcontroller Platforms: Design and debug firmware specifically for microcontroller-based architectures. Driver Development: Develop and maintain low-level device drivers for peripherals including UART, SPI, I2C, GPIO, ADC, DAC, and PWM. Hardware Integration: Collaborate with hardware teams on schematic reviews, board bring-up, and integration debugging. Testing & Validation: Perform unit testing, integration testing, and Hardware-in-the-Loop (HIL) testing. Troubleshooting: Identify, analyze, and resolve complex firmware and system-level issues. Documentation: Maintain detailed records of firmware architecture, APIs, and development processes. Process Improvement: Support the evolution of firmware development standards and best practices. Qualifications & Experience Education: B.E./B.Tech or M.E./M.Tech in Electronics, E&C Engineering, or a related field. Experience: 5 8 years of professional experience in embedded firmware development. Qualification : B.E./B.Tech or M.E./M.Tech in Electronics, E&C Engineering or a related field