46 Ichgcp Jobs - Page 2

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...

The Manager 2-Clinical Data Management at Sun Pharmaceutical Industries Ltd in Gurgaon - R&D is responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance to SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP and local regulations. The incumbent will be managing all data management aspects of assigned project(s) from setup to lock, attending regular meetings with the project team to discuss data management issues, and providing status updates. Reporting on quality and performance metrics, including timelines, to project leads and other stakeholders ...

Precision for Medicine is looking for an experienced Clinical Data Associate/Senior Clinical Data Associate to provide comprehensive data management support throughout all phases of the clinical trial data management process. In this role, you will ensure adherence to Standard Operating Procedures (SOPs), regulatory guidelines, and study-specific plans under direct supervision. Your responsibilities will include data cleaning and reconciliations, database testing, quality control, and collaboration within a dynamic team environment. The Clinical Data Associate/Senior Clinical Data Associate will provide data management support and assistance in all aspects of the clinical trial data manageme...

You will play a crucial role in producing key data and reports to support data review reporting development. This involves evaluating requirements, designing specifications, coordinating with programmers, programming reports, and ensuring validation and rollout activities are carried out effectively. You will provide quantitative analytical support independently or as part of a team, with minimal guidance and supervision. Your primary responsibilities will include: - Producing and tracking reports for various line functions within Global Drug Development to monitor clinical data - Creating understandable and actionable reports on clinical data for key stakeholders - Collaborating on user req...

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Senior Clinical Data Manager I to join our A-team (hybrid*). The Senior Clinical Data Manager I (SrCDM1) is responsible for leading data management activities of the Allucent Data Management (DM) department. In this role, you will manage, coordinate, review, and approve DM deliverables from database design & set-up, through cleaning and reporting to database locking. It is crucial to ensure that the completeness, accuracy, and consistency of clinical data meet the...

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are seeking a skilled SAS Clinical Programmer III with experience in SAS and EDC programming to join our dynamic team. In this role, you will leverage your expertise in SAS programming and clinical data management to support the analysis and reporting of clinical trial data. Your contributions will be pivotal in ensuring the accuracy and integrity of our clinical databases. As a Clinical Programmer III at Allucent, you will lead and coordinate clinical programming activities and ma...

Job Title: Medical Data Abstractor (MDA) Department: Delivery Job Location: Turbhe, Navi Mumbai (Work from Office) Reporting To: Lead Job Duties / Responsibilities: Data management and Curation Performs complex data abstraction (i.e. requiring interpretation) and data entry for specified disease and project requirements. Participates and contributes to team meetings and learning sessions. Maintains a high level of medical knowledge and terminology and expertise of electronic medical record and data capture systems. Self-reports activities like time spent on records, audits completed including all relevant details and any other reporting functions assigned by Operations and QA management team...

You will be responsible for effectively participating in the start-up and completion of multiple Data Management projects according to stakeholder requirements and in accordance with SOPs and other applicable standards in compliance with Sun Procedural Documents, ICH-GCP, and local regulations. Your duties will include managing all data management aspects of assigned project(s) from setup to lock. You will attend regular meetings with the project team to discuss data management issues and provide status updates for the project. Reporting on quality and performance metrics, including timelines, to project leads and other stakeholders will also be part of your responsibilities. You will partic...