Clinical Trials Quality Assurance

Job OverviewCorrective and Preventative Action (CAPA) and Effectiveness Check (EC) plan review, approval and closure and Audit plan development. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies,...

**Job Overview** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. **Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining...

Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

**Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. - Assist the clinical team with the preparation, handling, distribution,...

PROFILE Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global levels. RESPONSABILITIES-...

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.When you're part of Thermo Fisher Scientific, you'll do challenging work, and be part of a team that values performance, quality and...

Typical Accountabilities Assists in coordination and administration of clinical studies from the startup to execution and closeout. Interfaces with Investigators, external service providers and CRAs during the document collection process to support effective delivery of a study and its documents. Serves as local administrative main contact and works closely...

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

Prepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...

Clinical Data ManagerSouth Africa | Remote DFnet provides data management, biostatistics, and software development services for industry, nonprofit, and academic organizations worldwide. Since 2004, DFnet's people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global health. DFnet...

**Summary of The Position**: The Medical Writing Manager is tasked with the writing of trial-related documentation for clinical projects undertaken by the Company in accordance with ICH GCP and local legal requirements, European, FDA and other international guidelines, as well as Company (and sponsor, if applicable) Procedural Documents. The Medical Writing...

**Clinical Data Manager** **South Africa | Remote** - DFnet provides data management, biostatistics, and software development services for industry, non-profit, and academic organizations worldwide. Since 2004, DFnet’s people, products, and services have helped our global clients with over 100 Phase I through Phase IV clinical trials. Our focus is global...

**Introduction** Through our client-facing brands Metropolitan and Momentum, with Multiply (wellness and rewards programme), and our other specialist brands, including Guardrisk and Eris Property Group, the group enables business and people from all walks of life to achieve their financial goals and life aspirations. **Role Purpose** Perform quality...

**Introduction** Momentum Life is looking for a client focus and determined Quality Assurer to join our team. Myriad is Momentum's market-leading life insurance product, providing life cover to clients in South Africa. Our Myriad product aims to partner with our clients on their journey to success. We strive to find opportunities in every risk and ensure...

Summary of The Position:The Medical Writing Manager is tasked with the writing of trial-related documentation for clinical projects undertaken by the Company in accordance with ICH GCP and local legal requirements, European, FDA and other international guidelines, as well as Company (and sponsor, if applicable) Procedural Documents. The Medical Writing...

Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

Job Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions - Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance...

Advert Reference: P8913 Project Co-Ordinator: Trial Setup Job Title: Project Co-Ordinator: Trial Setup Closing Date: 2024/02/09 Position Available From: 2024-02-02 Area: Centurion Actual Place Of Work: Centurion Position Type: Full-Time Weekly Hours: 40 Time Conditions: 5 day Work Week (South Africa) Purpose of Position: To set-up trials according...

**Essential Functions**: - Expected to be the accountable point of contact for designated clients, responsible not only for RA deliverables but also for proactive communication and budget adherence. - Act as the Lead Regulatory Professional for regulatory projects awarded to FHIC, with support from other senior colleagues. - Provides Clinical Research...

**Introduction** As a Quality Controller (QC) within RISO, you will be one of Momentum's brand representatives. The main purpose of your role will be to accurately perform quality control and assurance of data on business systems to ensure standards are met as well as to maintain and monitor the quality assurance process. **Role Purpose** Your role will...