32 Ichgcp Jobs

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...

Role Overview: You will be joining as a Senior Associate/Specialist Document Coordinator, supporting the Global Medical Writing Team in delivering its portfolio effectively and efficiently. Your main responsibilities will include managing the quality review of clinical and regulatory documents, such as Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, Clinical Summary documents, PBRER, DSUR, and RMP. Key Responsibilities: - Conduct quality review of clinical and regulatory documents - Participate in meetings related to medical writing, quality control, and compliance activities - Collaborate cross-functionally to continuously improve medical writing processes - Famil...

You will play a crucial role in Statistical Programming, providing high-level support for a variety of clinical trials as a consultant, both internally and externally. Your contributions will significantly impact the standardization of Statistical Programming processes and project management. This position offers the opportunity to work remotely from home. As a Principal candidate, you should have over 10 years of experience with at least 2 years of people management. For Senior candidates, 7-9 years of experience with project management exposure is required. Your responsibilities will include serving as a Statistical programming lead for large global or major programs, offering technical so...

As a Data Entry Assistant in this role, you will be responsible for supporting the data management processes of clinical trial data in accordance with Good Clinical Data Management Practices (GCDMP). Your key tasks will include assisting in data entry, validation, and cleaning procedures to ensure accuracy and compliance. You will also play a crucial role in aiding the development and testing of Case Report Forms (CRFs) and electronic data capture (EDC) systems. Additionally, you will be tasked with managing discrepancies and data queries efficiently to address any data issues that may arise during the process. Maintaining detailed study-specific documentation, such as data management plans ...

At Allucent, we are dedicated to assisting small-medium biopharmaceutical companies in efficiently navigating the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. The Clinical Data Manager I (CDM1) plays a crucial role in supporting various data management activities within the Allucent Data Management (DM) department. This position involves collaborating with other Allucent Clinical Data Managers (CDMs) and Clinical Programmer(s) to ensure the quality standards and regulatory requirements for analysis and reporting are met. Your key tasks in this role will include: - Assisting in various data management tasks and collaborating with Lead...

This is a supervisory position responsible for overseeing a team of eTMF Specialists, who are accountable for document upload and management in the electronic Trial Master File (eTMF) to support BMS Clinical Trials. As the supervisor, you will manage the allocation of workload among the team, ensuring tasks are completed efficiently and accurately. Your role involves overseeing the upload and quality reviews of electronic documents in the eTMF system to guarantee they are inspection-ready and compliant with the ICH/GCP and ALCOA Plus principles. You will be responsible for training and supervising the team to ensure they accurately complete attributes, metadata, and workflows for uploaded do...

Precision for Medicine is looking for a skilled Medical Coder to provide comprehensive Coding and related data management support during all phases of the clinical trial data management process. Working under direct supervision with a team of medical coders, you will ensure compliance with Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans. This role involves various responsibilities, including data coding, quality review, and collaboration within a dynamic team environment. The Coder will be responsible for providing Coding in both MedDRA and WHODRUG dictionaries for assigned Studies on a full-time basis. They will follow Standard Operating Procedures/Work...

As a Sr CRA I based in Beijing at Syneos Health, you will play a crucial role in monitoring clinical research studies to ensure they are conducted in line with established clinical practices. You will be responsible for both on-site and remote monitoring, developing tools, procedures, and processes to maintain quality monitoring standards. Your dedication to contributing to the design, implementation, and delivery of processes and programs will be instrumental in the success of clinical research studies. Syneos Health is committed to fostering a supportive and engaging work environment where career development, progression, and peer recognition are prioritized. As part of our Total Self cult...

As a Senior Clinical Operations Specialist (Senior CTA) in the Hybrid model in Athens at Syneos Health, 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, maintaining project files, handling project correspondence, participating in file audits, and preparing and maintaining site manuals and reference tools. Additionally, you will be responsible for updating clinical tracking information into databases, tracking documents, managing the shared mailbox, and coordinating site supplies and ma...

Are you ready to make a significant impact in the world of Biopharma Clinical Operations As an Associate Director in GCS Business Technology Solutions, you'll be at the forefront of driving industry-leading processes, technology, and services. Your role will be pivotal in owning the lifecycle management and continuous improvement of specific clinical operations processes, systems, or services. Collaborate with internal and external stakeholders to ensure customer needs are met and optimize the delivery of clinical studies. You'll identify and deliver improvements using tools like Lean Six Sigma to improve clinical study delivery. Are you up for the challenge Design, develop, implement, maint...

The Senior Analyst II role involves developing and maintaining Tableau dashboards and utilizing SQL programming to support clinical data management and analysis. A strong technical background and understanding of clinical trial domains are essential. Responsibilities include designing interactive Tableau dashboards, optimizing SQL databases, analyzing study requirements, managing data discrepancies, collaborating with clinical teams, ensuring data quality, and providing technical documentation. The role also involves troubleshooting data-related issues and staying updated on industry best practices. Qualifications: - Minimum of a 4-year college degree in a relevant discipline - 5 years of ex...

At Allucent, you will play a crucial role in helping small-medium biopharmaceutical companies navigate the world of clinical trials to deliver life-changing therapies to patients worldwide. As a Sr. Clinical Research Associate Contractor (Sr.CRA) on our remote A-team, you will have the opportunity to independently manage and monitor investigational sites, ensuring adherence to trial protocols, SOPs, regulations, and Good Clinical Practice standards. Your responsibilities will include maintaining the highest quality standards for trial monitoring activities, overseeing site activities to ensure protocol compliance, preparing detailed reports, updating CTMS systems, and providing support to th...

As a Manager in GCS Business Technology Solutions at AstraZeneca, you will play a crucial role in leading and innovating in the realm of Biopharma Clinical Operations. Your primary responsibility will be to design, develop, and continuously improve processes, systems, and services that drive clinical study delivery. You will collaborate with internal and external stakeholders to meet customer needs and enhance the efficiency of clinical studies. Utilizing tools like Lean Six Sigma, you will identify and implement improvements to ensure optimal end-to-end delivery. Are you ready to make a difference in this dynamic and challenging role Your key accountabilities will include designing, develop...

As a Data Management Specialist, you will be responsible for designing and reviewing Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems. You will develop and maintain Data Management Plans (DMPs), data validation specifications, edit checks, and coding guidelines. Your role will involve overseeing data entry, data cleaning, discrepancy management, and query resolution processes to ensure data integrity. It will be your responsibility to ensure compliance with industry standards such as CDISC (CDASH, SDTM) and regulatory guidelines from FDA and ICH-GCP. You will be involved in conducting User Acceptance Testing (UAT) of EDC systems and monitoring data quality throughout the pr...

The Clinical Data Manager is responsible for overseeing all data management activities pertaining to the conduct of Phase I-IV clinical trials in accordance with ICH/Good Clinical Practices (GCP) and other relevant procedures and guidelines to ensure that a quality work product is produced and timelines and deliverables are met. Participate as the primary data management representative on the QED multidisciplinary project teams and as the primary point of contact for all data management interactions with the Sponsor. Participate in protocol developments and review, in review of clinical study reports and statistical analysis plan, in the development of data dictionaries complete with variabl...