46 Ichgcp Jobs

As an experienced Quality Assurance (QA) professional with expertise in ICH-GCP and GLP principles, your role at MSCR will be crucial in ensuring the highest standards of quality and compliance across clinical research and laboratory operations. You will be responsible for developing and maintaining ICH/GCP-compliant processes, leading internal quality audits, conducting study audits, and driving continuous quality improvement initiatives. Your role will also involve ensuring GLP compliance, managing documentation and SOPs, overseeing study conduct, and liaising with regulatory authorities. Key Responsibilities: - Develop and maintain ICH/GCP-compliant processes for controlling the quality o...

As a Clinical Research Trainer at PMCTI (Pune Medical Coding Training Institute), your role involves delivering training sessions on Clinical Research, GCP (Good Clinical Practice), Regulatory Affairs, Pharmacovigilance, and related topics. You will be responsible for designing, updating, and improving training materials, presentations, and assessments. It will be your duty to assess and evaluate trainees" understanding through tests, assignments, and practical exercises. Staying updated with the latest industry trends, guidelines, and regulatory changes is essential. You will conduct both classroom and online training sessions as per company requirements and provide career guidance and ment...

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As a Senior Regulatory Start Up Associate at Novotech, your role will involve planning, preparing, and reviewing country and site level ethics and regulatory authority applications and submissions during project start-up. Your responsibilities will include: - Serving as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) on allocated projects. - Providing expertise and guidance on country and local regulations, keeping abreast of developments and changes in regulations. - Working within the scope of relevant SOPs and ICH-GCP guidelines. - Providing country and site level information on submission deadlines and timeline metrics. - Ensuring compli...

As a Senior Clinical Data Manager I at Allucent, your role will involve leading data management activities within the Allucent Data Management (DM) department. You will be responsible for ensuring the completeness, accuracy, and consistency of clinical data to meet quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in data management areas, develop departmental processes, tools, and train staff. This position is based in Bengaluru. **Key Responsibilities:** - Lead and serve as the primary contact for data management with internal and external parties. - Plan resources, manage tasks, timelines, risks, and quality. - Develop, revi...

Job Overview We are seeking experienced QA Analysts with expertise in eTMF system implementation, GxP compliance, 21 CFR Part 11, and ICH-GCP. The role involves validation, compliance testing, documentation review, and supporting regulatory requirements across clinical and quality systems.This is a Chennai-based onsite role, suitable for candidates with strong experience in regulated environments. Key Responsibilities Lead and participate in eTMF system implementation and validation activities Ensure systems comply with GxP, 21 CFR Part 11, ICH-GCP, and audit requirements Perform validation, functional testing, and compliance reviews for clinical applications Review SOPs, validation delivera...

As a Senior Clinical Data Manager I at Allucent, you will play a crucial role in leading data management activities within the Allucent Data Management (DM) department. Your responsibilities will include managing, coordinating, reviewing, and approving DM deliverables from database design & set-up to database locking. It is essential to ensure the completeness, accuracy, and consistency of clinical data meeting quality standards and regulatory requirements. Additionally, you will provide expertise in data management areas, contribute to cross-functional initiatives, and participate in Request for Proposals (RFPs) and Business Development (BD) Meetings. Your key tasks will involve: - Leading ...

Role Overview: You will be responsible for overseeing all data management activities related to Phase I-IV clinical trials, ensuring adherence to ICH/GCP guidelines. Your role is crucial in producing quality work products and meeting project timelines. Key Responsibilities: - Participate as the primary data management representative on multidisciplinary project teams and act as the main point of contact for data management interactions with the Sponsor. - Contribute to protocol development, review of clinical study reports, statistical analysis plans, and development of data dictionaries. - Review and provide inputs on CRF design, database design, data validation plans, and revisions to Stan...

As a member of the inclusive team at Astellas, you will be part of developing innovative therapies for patients. The company is dedicated to turning innovative science into medical solutions that bring value and hope to patients and their families. By focusing on addressing unmet medical needs and operating with ethics and integrity, Astellas strives to enhance the health and well-being of people worldwide. **Key Responsibilities:** - Collaborate with cross functional stakeholders as process requires, including feasibility, study start up, contracts, budget, and study team members. - Bachelor's Degree or equivalent relevant experience. - Understanding of the regulatory, legal, and data priva...

As a Senior Clinical Data Manager I at Allucent, your role involves leading data management activities in the Allucent Data Management (DM) department. You will be responsible for managing, coordinating, reviewing, and approving DM deliverables from database design & set-up to database locking. It is crucial to ensure the completeness, accuracy, and consistency of clinical data to meet quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas, participate in cross-functional initiatives, and contribute to the development of departmental processes, tools, and staff training. Your involvement in Request ...

As a Junior Clinical Research Associate at Clinogenesis Research Organization, you will play a crucial role in supporting the clinical operations team and contributing to high-quality clinical trials. **Key Responsibilities:** - Assist in site initiation, monitoring & close-out activities - Support review of study documents & source data verification - Maintain trial documentation & ensure GCP compliance - Coordinate with site teams & internal stakeholders - Assist in reporting, study tracking & CAPA follow-ups - Ensure patient safety and protocol adherence **Qualifications:** - Bachelors/Masters in Life Sciences / Pharmacy / Nursing / Biotechnology - 01 year of experience - Understanding of...

As a Senior Clinical Operations Specialist (Senior CTA) at Syneos Health in Athens, you will play a crucial role in ensuring compliance with Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. Your responsibilities will include: - Assisting Clinical Monitoring staff with site management activities, acting as a Sponsor representative for assigned sites, and ensuring compliance with protocol requirements and study procedures. - Creating and maintaining project files, handling project correspondence, and participating in file audits. - Preparing and updating site manuals, reference tools, and other documents. - Inputting clinical tracking informatio...

As a Senior Analyst II at the company, your role will involve developing and maintaining Tableau dashboards and utilizing SQL programming to support clinical data management and analysis. Your responsibilities will include: - Designing, developing, and maintaining interactive Tableau dashboards for visualizing clinical trial data and aiding decision-making processes. - Creating, managing, and optimizing SQL databases and queries to efficiently store, retrieve, and analyze clinical trial data. - Analyzing study requirements, Case Report Forms (CRFs), and protocol information to ensure accurate data capture and reporting. - Identifying, investigating, and resolving data discrepancies to mainta...

As a Sr CRA I at Syneos Health in Beijing, you will play a crucial role in monitoring clinical research studies to ensure trials are conducted in accordance with widely accepted clinical practices. Your responsibilities will include conducting on-site and remote monitoring, developing tools and procedures for quality monitoring, and ensuring regulatory, ICH-GCP, and protocol compliance at all stages of the clinical trial process. Key Responsibilities: - Ensure regulatory, ICH-GCP, and protocol compliance during site qualification, site initiation, interim monitoring, site management, and close-out visits - Evaluate overall site performance, provide recommendations for site-specific actions, ...

As a Quality Assurance GLP professional at MSCR, your role involves ensuring the highest standards of quality and compliance across clinical research and laboratory operations by leveraging your expertise in ICH-GCP and GLP principles. You will be responsible for various key activities: - Develop and maintain ICH/GCP-compliant processes at MSCR. - Lead internal quality audits, CAPA activities, and quality management reviews. - Conduct study audits to ensure adherence to sponsor protocols, GCP, and regulatory requirements. - Identify non-conformances, recommend corrective measures, and drive continuous quality improvements. - Perform vendor audits, collaborate with production support teams, a...

As a Senior Document Management Associate (DMA) at Advanced Clinical, you will be instrumental in maintaining the Trial Master File (TMF) to ensure the smooth progress of clinical trials. Your duties will include: - Creating study-specific TMF Plans and Indexes - Processing TMF documents in compliance with industry standards - Conducting TMF Reviews - Delivering internal and external TMF training You will collaborate closely with the TMF Manager to devise TMF Plans and Indexes, process TMF documents through classification, metadata indexing, and Intake QC reviews. Furthermore, you will conduct TMF Reviews according to the TMF Plan, rectify missing documents, and monitor pending tasks. Effect...

Your role as a candidate will involve: - Assisting in subject recruitment, screening, and informed consent processes - Collecting, entering, and managing clinical trial data and documentation - Scheduling study visits, communicating with study participants - Ensuring regulatory and ethical compliance (e.g., ICH-GCP, IRB submissions) Qualifications required: - Proficiency in subject recruitment, data management, and regulatory compliance - Excellent communication skills and attention to detail This is a full-time position with benefits such as health insurance and Provident Fund. The work schedule is day shift, and the work location is in person.,

As a Senior Clinical Data Associate at our company, you will play a crucial role in providing support and assistance throughout the clinical trial data management process for assigned projects. Your responsibilities will include: - Supporting the Lead DM as a back-up or team member to ensure tasks are performed in a timely manner - Performing data entry for paper-CRF studies when necessary - Conducting quality control of data entry - Providing input into timelines and assessing resource needs for projects - Developing CRF specifications and coordinating feedback from stakeholders - Assisting in building clinical databases and conducting database build UAT - Specifying requirements for variou...

Do you want to be part of an inclusive team that works to develop innovative therapies for patients Every day, you are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. They are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping the focus on addressing unmet medical needs and conducting business with ethics and integrity enables them to improve the health of people throughout the world. **...

Role Overview: As the Clinical Data Manager, you will be responsible for overseeing all data management activities related to Phase I-IV clinical trials. Your role will involve ensuring compliance with ICH/Good Clinical Practices (GCP) and other relevant guidelines to maintain high-quality work products and meet timelines and deliverables. Key Responsibilities: - Participate as the primary data management representative on the QED multidisciplinary project teams. - Serve as the main point of contact for all data management interactions with the Sponsor. - Contribute to protocol developments and reviews, as well as review of clinical study reports and statistical analysis plans. - Assist in t...

As a Senior Regulatory Start-Up Associate at the company, your primary responsibility will be to plan, prepare, and review country and site level ethics and regulatory authority applications and submissions during project start-up. Your role is crucial in ensuring compliance with ICH-GCP and local regulatory requirements to facilitate timely clinical trial approval. Your key responsibilities will include: - Serving as the primary point of contact for the Regulatory Start-Up Manager (RSM) and/or Project Manager (PM) during start-up on allocated projects. - Providing expertise and guidance to RSM and/or PM on country and local regulations and practices, staying updated on developments and chan...

You will be responsible for leading the development and finalization of key clinical trial documents with a focus on scientific accuracy, regulatory compliance, and clarity. Your role will require close collaboration with cross-functional teams to support the entire lifecycle of clinical documentation, from protocol development to submission-ready deliverables. Key Responsibilities - Lead the drafting and review of clinical trial protocols in coordination with medical, regulatory, and operational teams. - Prepare high-quality clinical documents such as Clinical Study Reports (CSRs), Investigators Brochures (IBs), Informed Consent Forms (ICFs), subject-facing materials, and study training doc...

As an experienced Quality Assurance (QA) professional with 8-10 years of experience in clinical research, pharmaceuticals, or life sciences, you will play a crucial role in ensuring the highest standards of quality and compliance at MSCR. Your expertise in ICH-GCP and GLP principles will be essential to maintain regulatory guidelines, clinical QA processes, and GLP compliance throughout the organization. Key Responsibilities: - Develop and maintain ICH/GCP-compliant processes to control the quality of work and clinical studies at MSCR. - Lead and manage internal quality audits, CAPA activities, and quality management reviews. - Conduct study audits to ensure adherence to sponsor protocols, G...

In your role as a Senior Clinical Data Manager I at Allucent, you will be responsible for leading data management activities within the Allucent Data Management department. Your tasks will include: - Serving as the primary contact for data management with relevant internal and external parties. - Planning and projecting required resources, managing tasks, timelines, risks, and quality. - Monitoring tasks, budgets, forecasts, and managing changes in scope, budget, and revenue recognition. - Developing, reviewing, and maintaining project-specific data management documents throughout the project lifecycle. - Leading and coordinating the development of clinical study database set-up and eCRF des...

Role Overview: At Allucent, you will be a Senior Clinical Data Manager I (SrCDM1) responsible for leading data management activities within the Allucent Data Management (DM) department. Your role will involve managing, coordinating, reviewing, and approving DM deliverables throughout the project lifecycle, ensuring the completeness, accuracy, and consistency of clinical data meet quality standards and regulatory requirements. Additionally, you will provide expertise in data management areas, cross-functional initiatives, and be involved in Request for Proposals (RFPs) and Business Development (BD) Meetings. Key Responsibilities: - Lead and serve as the primary contact for DM with relevant pa...