14 Protocol Jobs

The Sr. Clinical Research Coordinator position at Shree Clinical Research in Belgaum is a full-time on-site role that involves overseeing clinical trials, managing protocols, and ensuring regulatory compliance. In this role, you will be responsible for obtaining informed consent, coordinating with investigators, sites, and patients, and ensuring the smooth execution of clinical research activities. To qualify for this position, you should have experience in Clinical Research and Clinical Trials, proficiency in handling Informed Consent, knowledge of Protocol and Research methodologies, strong organizational and communication skills, and the ability to work both independently and collaboratively. A Bachelor's degree in a relevant field like Life Sciences or equivalent experience is required. Familiarity with ICH GCP and SOPs is considered a plus. Shree Clinical Research focuses on conducting multi-centre, multi-geography clinical trials and aims to establish long-term partnerships with Sponsors, investigators, sites, and patients. Equipped with ICH GCP and SOPs, the company ensures that all clinical trial activities adhere to regulatory principles and guidelines, maintaining the highest standards of ethics to safeguard patient safety and confidentiality.,

At 7Rays Semiconductors, we specialize in providing comprehensive VLSI design solutions to assist our clients in achieving excellence in execution. Our team of experts is highly skilled in various areas including architecture, RTL design, verification, validation, physical design, implementation, and post-silicon validation. We utilize the latest technologies and methodologies to deliver top-notch solutions tailored to meet our clients" specific needs. As a Design Verification Engineer specialized in protocols such as PCIe, CXL, and UCIE, you will be responsible for: - Demonstrating expertise in interconnect protocols such as PCIe, CXL, and UCIE. - Having a solid understanding of AXI/ACE/CHI protocols, with a particular emphasis on AXI. - Knowledge of DMA usage and its applications. - Strong proficiency in SystemVerilog (SV) and Universal Verification Methodology (UVM). - Experience in utilizing standard Verification IP (VIP) in Testbenches, preferably Synopsys tools. - Familiarity with AI/ML network concepts is considered beneficial. - Additional proficiency in perl/tcl scripting would be advantageous. The ideal candidate for this role should possess a Bachelor's Degree in Electrical, Electronics, or Computer Engineering, along with 5-12 years of relevant experience. If you are passionate about semiconductor design, eager to work in a collaborative environment, and committed to delivering high-quality solutions, we would love to hear from you.,

As an experienced medical writer with expertise in CTD medical writing and clinical development of medicines, your responsibilities will include the following: Writing high-quality CTD modules such as nonclinical and clinical overviews & summaries (Module 2.5, 2.4, 2.7, 2.7) to meet EU submission requirements. Addressing clinical deficiencies by providing appropriate responses. Contributing to drug development strategy. Updating documents like SmPC, Patient Information Leaflet, CCDS, Safety variations. Preparing Clinical Study Reports, Study design, and synopsis. Assisting in the formulation of clinical development strategies and reviewing study reports and published papers. Conducting literature searches and regulatory evaluations. Evaluating Rx to OTC transitions. Handling tasks such as PSURs, PADER, and RMP. To be considered for this role, you should have the following qualifications and skills: MBBS in Medicine/ M.Pharma in Pharmacy/ Medical-MS/MD in Pharmacology/ Ph.D/Doctorate in Pharmacy. Prior experience in medical writing for regulatory submissions in Europe. Expertise in areas like non-clinical overview, clinical overview, PSUR, EU submission, Clinical Pharmacology, module 2.5, Scientific Writing ICH, Regulatory Submissions, Medicine, DCP, CTD, Clinical Research, medical writer, Medical Writing, and EMA labelling Module 2.4. Demonstrated scientific accuracy and attention to detail. Understanding of Generic, Hybrid, and New drug applications. Proficiency in Clinical study design and protocol development. Excellent communication abilities and efficient time management. Specialization in Pharmacology would be advantageous for this role.,

Job Title: Technical Lead PAPIS Project (Public Address & Passenger Information System) Location: Talwade, Pune. Department: Engineering / Product Development Experience: 4 - 7 years Employment Type: Full-time Job Summary: We are looking for a proactive and technically skilled Technical Lead to manage and guide the engineering activities for our PAPIS (Public Address & Passenger Information System) project. The ideal candidate will take ownership of BOM management, ensure strict adherence to RDSO and regulatory standards, and collaborate with cross-functional teams across hardware, software, QA, and production to deliver high-quality, field-ready products. Key Responsibilities: Lead the creation and maintenance of Product-Level Bill of Materials (BOM) for PAPIS hardware and sub-systems. Ensure the product complies with RDSO, AIS-140, CE, RoHS, ISO, and other relevant standards. Interface with the hardware design team for schematic reviews, component validation, and interface planning. Collaborate with the software/firmware team to align product features, system integration, and testing timelines. Own and update technical documentation, including wiring diagrams, installation manuals, interface documents, and test plans. Coordinate with compliance and testing agencies to ensure certifications and approvals are completed on time. Support prototype development, integration testing, and field deployment activities. Liaise with procurement and suppliers for part specifications, sourcing alternatives, and ensuring DFM compatibility. Lead technical issue resolution, perform root cause analysis, and drive product improvement initiatives. Guide and mentor junior engineers working on the PAPIS product lifecycle. Required Skills & Qualifications: Bachelors degree in Electronics, Electrical, Instrumentation, or a related engineering field. 4 - 7 years of experience in embedded systems, hardware-software integration, or transport/ITS domain. Hands-on experience in managing BOMs, design reviews, and product configuration in ERP. Strong knowledge of compliance and certification processes including RDSO, AIS-140, and other transport-related standards. Excellent communication and leadership skills to coordinate across multi-disciplinary teams. Experience with product validation, testing, and technical documentation.

As an HVAC & Portable Water System Technician, you will be responsible for ensuring the healthy operation of HVAC equipment with minimal breakdowns. This includes conducting maintenance operations and troubleshooting of electrical panels, as well as managing the portable water system throughout the entire plant. You will also be required to validate the HVAC system regularly to ensure the healthiness of the AHU system. Additionally, you will be responsible for in-house installation work related to the HVAC system, maintaining log keeping in compliance with QMS standards, executing breakdowns, maintenance, and troubleshooting of the HVAC system, and managing inventory control to prevent equipment downtime. Safety concerns should be a top priority to avoid accidents during work, and providing training to junior staff for better job performance is essential. In terms of new projects, you will be involved in planning changes in facility, executing the changes, validating and qualifying them, and eventually handing them over to the end users. It will also be your responsibility to supervise the preparation of QMS documents for HVAC validation, including SOPs, protocols, reports, and ensuring compliance with current guidelines. Handling deviation and change control related documents will also fall under your purview. You will be involved in vendor selection and qualification for validation activities, as well as planning and executing HVAC validations according to predefined SOP protocols. Effective inventory management for critical spare parts to reduce equipment downtime will also be a key aspect of your role.,

Join our dynamic team at Ericsson as a Solution Architect. As a Solution Architect, you will analyze, design, and develop commercially viable technical solutions based on customer specifications and business needs. Your role will involve creating short- and long-term profitable business strategies by working closely with the Core 3 team to translate customer needs and technology opportunities into detailed technical offerings and proposals. Your responsibilities will include engaging in detailed discussions with customers to understand their technology strategy, analyzing their technology and business environment, and identifying improvement areas and challenges. Collaboration with the Core 3 team to develop potential activities and solutions, constructing value arguments, and developing technical presentations for customers will be key aspects of your role. The skills required for this position include consultative skills, solution delivery, project implementation, negotiation, expertise in hardware, architecture, virtual environment, technology, protocol, and interface, coaching and mentoring abilities, financial acumen, customer solution design, market insights, knowledge sharing and learning, familiarity with Ericsson portfolio, business acumen, expertise in infra capacity, performance analysis, and solution definition, and technical sales proficiency. Join us to contribute to Ericsson's success by leveraging your skills as a Solution Architect.,

Role & responsibilities Utilize strong L2/L3 networking skills to test and validate security product features. Conduct thorough testing of security products including SSL, firewall, next-generation firewall, Snort, IPS, IDS, and VPN. Plan and strategize release cycles, test strategies, and test execution plans. Coordinate effectively among various teams to ensure timely releases. Track defects and perform root cause analysis (RCA) to improve product quality. Communicate effectively with cross-border teams and stakeholders to facilitate timely releases. Test various traffic flows and utilize traffic generator tools for comprehensive testing. Guide and mentor engineers to identify and report more bugs. Experience with ASA and FTD is a plus. Good experience in manual testing

Join our dynamic team at Ericsson as a Solution Architect where you will be analyzing, designing, and developing commercially viable technical solutions in your respective technical domain. Your main responsibility will be to create short- and long-term profitable business strategies for Ericsson by closely collaborating with the Core 3 team to translate customer needs and technology opportunities into detailed technical offerings, solutions, and proposals. Your key responsibilities will include: - Utilizing strong analytical and problem-solving skills to translate complex business requirements into innovative solutions. - Demonstrating excellent communication and interpersonal skills to effectively collaborate with cross-functional teams and communicate technical concepts to non-technical stakeholders. - Managing multiple projects simultaneously in a fast-paced, agile environment. - Bringing a minimum of 6 years of experience in the fintech industry, with a proven track record of delivering successful fintech/Wallet projects and solutions. - Providing expert guidance and strategic advice to senior management on fintech-related initiatives, opportunities, and risks. - Ensuring compliance with regulatory requirements and industry standards related to fintech/Wallet in all solutions. - Acting as a subject matter expert and thought leader on fintech topics, both internally and externally. - Collaborating with external partners, vendors, and 3PPs for requirement analysis, requirement gathering, and conducting workshops. - Leading end-to-end solution discussions, design, implementations, and integration. - Demonstrating understanding of AI/ML, AML, Fraud, security aspects, and ISO standards related to Fintech. - Possessing technical skills in UNIX, Solaris, DIAMETER, SMPP, HTTP, Oracle, Veritas Volume Manager, XML APIs, Clustering, MySQL, Python, IP-Networking, Rest/SOAP APIs. - Utilizing tools knowledge like MS Project or MS Visio. The skills you bring to the role include: - Consultative Skills. - Solution Delivery. - Project Implementation. - Negotiation. - Hardware, Architecture, Virtual Environment, Technology, Protocol, and Interface. - Coaching and Mentoring. - Solution Architect. - Financial Acumen. - Customer Solution Design. - Market insights. - Ericsson Portfolio. - Business Acumen. - Knowledge sharing and learning. - Infra Capacity, Perf Analysis, and Sol Def. - Technical Sales.,

Tech Lead - WiFi Job Location: Chennai Experience: 5 to 9 years Salary: Open Our Client is seeking passionate Firmware Tech Lead Engineer with 58 years of experience in developing Wi-Fi firmware. The role involves working on embedded software development for Wi-Fi 6/7 chipsets, focusing on Upper MAC/Lower MAC, Data and Control Paths, and performance optimization within RTOS environments. You will be part of the new Firmware Innovation Center in Chennai contributing to high performance wireless solutions. Key Responsibilities: Design, implement, and maintain Wi-Fi firmware modules related to: Data Path and Control Path Upper MAC/Lower MAC/PHY integration Wi-Fi 6 and Wi-Fi 7 protocol enhancements Debug critical firmware issues impacting performance, stability, and throughput. Collaborate with hardware, RF, and systems teams to ensure optimal firmware operation across layers. Develop and optimize firmware for real-time embedded environments, ensuring compliance with timing constraints and system KPIs. Participate in code reviews, bring-up, and delivery of firmware to production hardware. Support regulatory (FCC, ETSI etc.,) and feature compliance (e.g., DFS, CCA, Spectral Scan, etc.). Why Join? Be part of a Firmware Innovation Group under experienced leadership. Work on next-generation wireless technologies with cross-functional teams in a global environment. Work on bleeding-edge platforms and direct engagement with chipset vendors. A growth-oriented, fast-paced R&D culture where firmware leads the product innovation Requirements: 7-9 years of embedded software development focused on Wi-Fi or Cellular firmware. Strong knowledge of IEEE 802.11 protocols, especially Wi-Fi 6 and Wi-Fi 7 (MAC/PHY level) or similar technologies in Cellular(LTE/5G) Experience in real-time embedded systems and RTOS environments. Solid debugging skills for firmware bottlenecks, stability issues, and low-level Wi-Fi/Cellular stack problems. Hands-on experience with Qualcomm and/or Broadcom or MediaTek or Intel (or any other chipsets) Experience with Debugging tools: Wireshark, GDB, iperf, Sniffer Advantage: Experience with Qualcomm Wifi/Cellular chipsets Basic experience in host-side driver development (cfg80211/nl80211, netlink communication). Familiarity with Linux wireless applications (e.g., hostapd, wpa_supplicant). Knowledge of OpenWRT, Yocto, QSDK, and user-space tools for embedded Wi-Fi platforms. Knowhow about TDD/TDMA, FDD/FDMA Basic understanding of bootloaders, BSP bring-up, and U-Boot configuration. Familiarity with RF-related features such as: DFS Spectral Scan Transmit power and channel calibration Exposure to RF equipment (e.g., spectrum analyzer) and calibration procedures. Please share profile to anand@anvayainfo.com

Hi all, We are hiring for the role OT Security Specialist Experience: 7 - 9 Years Location: bangalore Notice Period: Immediate - 15 Days Skills: Job Description: We are seeking a highly skilled OT Security Expert with 7-9 years of experience to join our team in the automotive industry. The ideal candidate will have hands-on experience in OT security, proficiency with the OT vulnerability management tools, and the ability to draft process documents. This role requires a deep understanding of operational technology security and its application within the automotive sector. Key Responsibilities: • Drive OT security strategies-initiative globally. • Develop and implement OT security strategies and policies to protect automotive manufacturing systems and networks. • Conduct risk assessments and vulnerability analyses to identify and mitigate security threats. • Utilize the Otorio tool to monitor, detect, and respond to security incidents within OT environments. • Draft and maintain comprehensive process documents, including security protocols, incident response plans, and compliance reports. • Collaborate with cross-functional teams to ensure the integration of security measures into automotive production processes. • Provide training and guidance to staff on OT security best practices and procedures. • Stay updated with the latest industry trends, threats, and technologies in OT security. • Design and implement network segmentation and access control measures to safeguard OT systems. • Perform regular security audits and assessments to ensure compliance with industry standards and regulations. • Develop and execute incident response plans to effectively address and recover from security breaches. • Work closely with IT and engineering teams to ensure seamless integration of OT security measures with existing infrastructure. • Conduct forensic analysis and root cause investigations of security incidents to prevent future occurrences. • Participate in the development and testing of disaster recovery and business continuity plans. If you are interested drop your resume at mojesh.p@acesoftlabs.com Call: 9701971793

YOUR TASKS AND RESPONSIBILITIES: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspection/audit readiness. This role will be responsible for establishing the procedures and trainings of teams which ensure protection of human subjects from research risk, reliability/Integrity of the data, and thereby assures internal consistency and Quality Compliance measures. Systems and Processes: Develop, implement and maintain a Quality Management System (QMS) for clinical trial team in consultation with Head Quality Compliance & Training and ensure oversight on team on quality aspect as per defined SOPs and applicable regulations. Implement and oversee the Quality Compliance procedures/processes/systems for clinical trials managed by the Medical science and Clinical Operations department. To assist in designing a process to write, review and approve the risk assessments for new trials and for ongoing projects and working closely with Project Managers and Operation Head as needed. To ensure a process in place to provide assurance on review of all study documentation for accuracy, consistency and completeness. Ensure effective systems and processes in place to maintain consistency and quality compliance parameters in medical science, operations, data management and drug depot for end-to-end activities of each function as per applicable regulatory requirements. Work with Clinical Research QC team, Medical Science team, Clinical Operations team, Clinical Data Management team and Study Management team to create and implement study specific QC plans that outline the scope of Quality Compliance procedures to be followed during clinical trials, ensuring QC processes are in alignment with SOPs and study protocols. Ensure completeness of training of study team on SOPs and job specific training as per role and responsibilities. Ensure periodic review of training files for all study team. Assess and identify the training requirement of study team and ensure completion of training. Well versed with electronic systems used in Clinical Trial operations, Data Management and Project Management which includes project specific deliverables tracking and important milestone related alarms, protocol compliance tracking, deviations tracking and electronic systems used for managing Trial Master File (TMF) and Drug accountability. Assist in developing system/process to work with the clinical trial team to schedule pre-execution and post-execution QC activities to ensure that all requirements of the QC plans are planned as required and executed. Plan, design, and update process and systems for clinical trial activities like development and utilization of QC assessment parameters and other QC tools designed to document/track the QC review process for clinical research activities in line with recent regulatory requirement. Ensure Quality Management System at Medical Science, Data Management team, Operation team to ensure the department is ready for audit/inspection 24x7. Ensure periodic review of Vendors and renewals as per applicable policies & procedures. Identify and recommend process improvement initiatives where required. Create and evaluate metrics to assess performance and implement plans for course correction. Activities: Should be effective team player who can work closely with different study teams and collaborate well with team members to achieve defined QC targets. Develop and implement a risk-based and flexible approach to Quality Compliance (QC) within the function, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practices. Identify and decide team members job specific SOP training requirements in view of their role and maintain oversight of training to ensure all team members are trained on each SOP as required. Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team. Quality review of the clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement. Quality review of the clinical trial operation related activities, related tools, plans and documentation like site feasibility, site selection visit, site initiation, Ethic committee documentation, monitoring site specific reports, Site Documents, logs and close out activities in line with ICH GCP requirement, Indian and global regulatory requirement. Ensure Quality review of SOPs and oversight on quality parameters specific to Clinical Trial Supply Management (CTSM) and other activities like receipt, handling of study sample, labelling, storage, temperature monitoring systems and distribution to trial sites. Final QC review of study close out activities including returned goods reconciliation, inventory destruction processing and archiving of documents. Review and communication of QC findings to respective department in stipulated timelines. Arrange monthly meeting or meetings as and when required depending on criticality of the issues with concerned team to discuss and communicate the findings from QC reviews to the internal stakeholders via QC summaries, reports as required. Maintain the repository of QC findings as per the department and specific function and present the trend analysis, training requirement and action plan with timelines to Head Medical Affairs and clinical for course correction on quarterly basis. Ensure training of SOPs, on job training and reviewing training files on regular basis. QC review and Support in preparation of clinical study manuals/documents/Plan such as the IMP handling manual, Study plans. Ensure record maintenance for all activities for traceability in line with regulatory requirement. WHO YOU ARE: > 5 years’ experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department. Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills. Must have experience in handling audits & inspections of DCGI, US FDA. Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials. Experience of working in matrix business environments preferred. Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards. Quality oriented mindset and skill set. Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA). In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research. Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements. Have strong analytical and problem-solving skills and the ability to present solutions. Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization. Eye for details, Sense of urgency & desire to excel. Proficiency with Excel or other quality management systems/ tools. Result oriented and performance driven. Excellent interpersonal & communication skills to effectively interact with a broad range of audience.

Preferred candidate profile Technical Skills Languages : SystemVerilog, Verilog, C/C++ (basic) Verification Methodologies : UVM (Universal Verification Methodology), Assertion-Based Verification (SVA) Protocols : Experience with one or more of the following: PCIe Gen5/6 AXI4, AHB, APB DDR4/DDR5 USB 3.1/3.2 Ethernet, MIPI, or NVMe Tools : Synopsys VCS, Cadence Xcelium, Mentor Questa, Verdi, SimVision Debug : Waveform debugging (Verdi/DVE), assertions, log analysis

Experience range from 4+ years. Hands-on experience in Protocol: PCIe, LPDDR4 Experience with TB development from scratch Experience range from 4+ years. Hands-on experience in Protocol: PCIe, LPDDR4 Experience with TB development from scratch" Develop and execute comprehensive verification plans and test benches from scratch. Perform functional verification of digital designs using SystemVerilog and UVM. Verify complex protocols, specifically PCIe and LPDDR4, ensuring compliance with industry standards. Develop and maintain test environments and scripts. Debug and analyze simulation failures to identify root causes. Collaborate with design and architecture teams to ensure design quality. Participate in code reviews and contribute to improving verification methodologies. Document verification results and maintain detailed reports.

Key Skills: Automated Testing, Protocol, Python, ixia, CICD Roles and Responsibilities: Develop and execute automated test scripts to validate software functionality and performance. Collaborate with cross-functional teams to understand system requirements and design effective test strategies. Utilize tools like Ixia to test networking protocols and ensure compliance with industry standards. Build and maintain Python-based testing frameworks to enhance automation capabilities. Analyze test results, identify defects, and work closely with development teams to resolve issues. Participate in continuous integration and continuous deployment (CI/CD) processes to streamline testing efforts. Skills Required: Strong experience in automated software testing and test script development Proficiency in Python for building and maintaining test automation frameworks Hands-on experience with networking protocols and tools like Ixia Familiarity with CI/CD pipelines and integration of automated tests Ability to analyze complex systems, identify issues, and work with development teams for resolution Strong problem-solving skills and attention to detail Excellent communication and collaboration skills to work in cross-functional teams Education : Bachelor's degree in Computer Science or a related field.