26 to 50 of 66 Good Clinical Practice Jobs

The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to: * Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures … good clinical practices and other applicable regulatory requirements; * Validating product performance claims; * Supplying data for critical Regulatory submissions; * Defining the functional and clinical utility of investigational products, and * Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The … adhering to the policies of the quality system and achieving quality objectives through daily actions. JOB FUNCTIONS/RESPONSIBILITIES * Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Maintaining communication with study investigators to ensure studies are completed in a timely more »

The IVD Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics. Responsibilities include but are not limited to: * Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures … good clinical practices and other applicable regulatory requirements; * Validating product performance claims; * Supplying data for critical Regulatory submissions; * Defining the functional and clinical utility of investigational products, and * Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders. The … adhering to the policies of the quality system and achieving quality objectives through daily actions. JOB FUNCTIONS/RESPONSIBILITIES * Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout. Maintaining communication with study investigators to ensure studies are completed in a timely more »

exciting and growing Biotechnology company based in Oxford and am assisting them in a search for an Associate DIrector of Clinical Quality Assurance (GCP). The successful candidate will be reporting directly to the Head of QA and spearhead all activities related to GCP. Main Duties and Responsibilities include … Ensuring changes in GCP practices are communicated, adopted and implemented throughout the organisation by maintaining current knowledge of local and international regulations To create/author/approve or input into SOPs and policies for those relating to GCP activities To provide GCP training for staff including the preparation of … and delivery of training. To include onboarding/induction training and refresher training To take a lead role on behalf of QA on all GCP investigations including serious breaches and Urgent Safety Measures and to communicate these effectively within the organisation and escalation to the senior leadership team To represent more »

exciting and growing Biotechnology company based in Oxford and am assisting them in a search for an Associate DIrector of Clinical Quality Assurance (GCP). The successful candidate will be reporting directly to the Head of QA and spearhead all activities related to GCP. Main Duties and Responsibilities include … Ensuring changes in GCP practices are communicated, adopted and implemented throughout the organisation by maintaining current knowledge of local and international regulations To create/author/approve or input into SOPs and policies for those relating to GCP activities To provide GCP training for staff including the preparation of … and delivery of training. To include onboarding/induction training and refresher training To take a lead role on behalf of QA on all GCP investigations including serious breaches and Urgent Safety Measures and to communicate these effectively within the organisation and escalation to the senior leadership team To represent more »

Job summary We are looking for an experienced, enthusiastic, and motivated clinical pharmacist to join our established, friendly clinical pharmacy team. The post holder will be responsible for delivering clinical pharmacy services to a chosen sub-specialty of Medicine, which include Respiratory, Endocrinology, Gastroenterology, Cardiology, Care of … and Emergency Medicine. Main duties of the job Main duties include Acting as a role model and to deliver, develop and evaluate highly specialist clinical pharmacy services in accordance with the objectives set by the line manager. Providing a highly specialist clinical pharmacy service to patients within the … practicing pharmacist with the General Pharmaceutical Council Diploma in Pharmacy Practice or equivalent training Independent Prescriber or currently working towards IP Desirable ICH GCP Training Royal Pharmaceutical Society (RPS) faculty membership Postgraduate qualifications in Medical specialities Experience Essential Relevant and extensive post registration ward pharmacy experience including in medicine more »

Job Description We’re currently recruiting for a Regulatory Clinical Trial Strategy & Submissions Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 12 Month basis to be based at their office in Maidenhead/hybrid. The Role: Deliver … CTA regulatory strategies and operations for a designated portfolio of development compounds in specified geographic region. Ensure the submission strategy for clinical trials planned globally are in accordance with the overarching global regulatory strategy and any risks and issues are highlighted to the Global Regulatory Project Team and study … teams. Ensure study deliverables are achieved in accordance with global regulatory strategies and compliance with evolving global clinical trial and company procedures. Primary interface between Company and regulators. Populate and maintain regulatory databases, data collation and tracking of regulatory submissions. Participate in development of internal working procedures. Represent regulatory more »

interventional studies under your supervision according to agreed resources, budget and timelines complying with AstraZeneca Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. You will accountable for the performance of the Oncology sites selected; ensure that Oncology study sites are identified, qualified … assigned to the clinical trials. You will oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines. As the SMM Oncology Lead, you will be part of the Oncology SMM Leadership Team and line manage a dedicated group(s) of staff. … for national and international travel. Desirable for the role Very good knowledge of the Clinical Study Process, Procedural Documents and international ICH-GCP guidelines. Excellent knowledge of the Monitoring Process. Good understanding of the Study Drug Handling Process and the Data Management Process. Good knowledge of more »

Associate Director Clinical Biomarkers, Oncology EMU Are you interested in developing, integrating, and implementing innovative biomarker strategies for Oncology clinical development programs, including validation and integration of biomarker assays into clinical trials? If so, the Clinical Biomarker Lead role within Experimental Medicine Unit (EMU) could be … wide benefits and life at GSK on our webpage Life at GSK | GSK In this role you will Lead and/or contribute to clinical asset biomarker strategy within early and late-stage clinical development programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action … time. Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms Knowledge and track-record of working to GCP principles. Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment Strong more »

the Quality System by supporting global metrics generation and ‘lessons learned from audit/inspection’ · Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV. · Collaborate with the respective Functional Area Heads/representatives · Collaborate with the respective Global and Regional Quality Leads and functions · Ensure …/EXPERIENCE · Degree in natural science or equivalent number of years’ experience · Experience in Pharmacovigilance auditing (Qualification as an auditor preferred) · Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation · Expert … knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance · Experience in Monitoring, Quality Assurance and/or Good Clinical Practices · Exposure to inspections COMPETENCIES · Understanding of pharmacovigilance · Understanding of audits and more »

thinking and problem-solving abilities, with a proactive approach to regulatory challenges. Familiarity with quality management systems and regulatory compliance frameworks (e.g., GMP, GDP, GCP). Ability to thrive in a fast-paced, dynamic environment and effectively prioritize competing demands. more »

Lead Quality Advisor, Clinical Supply Quality Location: UK (Macclesfield) Type: Permanent Competitive Salary & Benefits Be proud to play a significant role to bring safe and effective new medicines to patients. We are adventurous, agile and pragmatic to enable our business to use innovative solutions and technologies to supply clinical trial materials to patients. Business area In the Clinical Supply Quality Team, we are responsible for quality in the development of new Clinical Trials and collaborations and the supply of Investigational Products to them. With a portfolio encompassing both small and large molecules, combination products and ground … and delivery. This may include all Quality aspects of projects including IT projects. Support Clinical Supply functions in GMP inspections and input to GCP inspections where required Approve Clinical Supply GMP documentation Contribute to release and other routine activities required in the clinical supply chain Support quality more »

Director, QA (GCP) Full-time, Permanent London- Hybrid Model Summary: I am currently working with a pioneering biotech reshaping healthcare through genetic engineering and personalized medicine. In this crucial position, as the Director QA GCP, your responsibility will be to assist upper management in guaranteeing that Quality remains a central … focus in all corporate endeavors. More specifically, you will serve as a consultant to the Clinical Development teams, providing guidance on GCP activities related to quality. Primary Responsibilities: Defining, maintaining, and monitoring the GxP Quality Management System (QMS). Making sure the QMS meets all the necessary regulatory requirements … with a strong focus on GCP compliance. Supporting and guiding the Clinical Development teams in defining compliant procedures within GxP functions and effectively managing quality issues. Handpicking and documenting responsibilities for external contracted organizations that support the GxP activities. Keeping a close eye on the performance of the GxP more »

bioanalytical studies. 3. A working knowledge and practical experience using LC-MS/MS. Key Words: Small Molecule | Study Manager | Team Lead | Bioanalysis | GLP | GCP | Method Development | Validation | Sample Analysis | Regulatory Compliance | LC-MS/MS Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by more »

bioanalytical studies. 3. A working knowledge and practical experience using LC-MS/MS. Key Words: Small Molecule | Study Manager | Team Lead | Bioanalysis | GLP | GCP | Method Development | Validation | Sample Analysis | Regulatory Compliance | LC-MS/MS Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by more »

their laboratories engaged in exploratory analysis of patient samples. You will be responsible for: Implementation of the company's quality management system relevant to GCP, including laboratory analysis of clinical samples, external vendor oversight, and training on quality procedures Acting liaison and support for Immunomonitoring and R&D labs … training to laboratory teams and eQMS users Plan and conduct of audits, including internal, vendors, clinical sites, and external laboratories Provide guidance on GCP/GCLP/GLP to clinical project teams You will bring the following: Previous experience in GCP QA role, as well as working in … Clinical laboratories Experience in Biologics, Steriles, CGT, or ATMP is highly desirable In depth knowledge of GCP and GCLP practices and regulations eQMS experience including implementation and administration more »

Job Description Working as a Senior Quality Expert/Manager - GCP, you will act as the advisor to the Clinical Development teams on all quality related GCP activities. This will be an exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets. Key Responsibilities: To … play a key role in maintaining and monitoring the GxP QMS ensuring it meets all regulatory requirements and standards, with emphasis on GCP compliance. To provide support and advice to Clinical Development teams with regards to: Definition of appropriate compliant procedures within GxP functions Management of quality issues To … the performance of GxP service providers with regards to the relevant quality standards. To define and manage clinical audit programme and to preform GCP audits if required. Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified. more »

responsibility for duties including: Designs and oversees the implementation quality management systems for CMC development activities including the release of product for GLP and GCP studies. Provides quality expertise in accordance with the global quality requirements in the creation of product characterisation, product specifications, method validation, stability and comparability assessments … in the collaboration with C(D)MOs. Ensures that there are robust processes in place for the review and release product for GLP and GCP studies. Ensures appropriate quality oversight of GMP activities performed by the Product Development teams at Dechra or CDMOs and contract laboratories. This may include review more »

an extremely cutting edge area of the life sciences space. chance to sit alongside the businesses senior leadership team, having full autonomy of the clinical division within the QA department. a small team of quality professionals, supporting with development and training. You will be responsible for: the businesses quality … high standard and aligns with regulations. CQA oversight and support to Pre-Clinical and Clinical Operations. and host regulatory inspections within the GCP remit. You will bring the following: extensive number of years working at a senior manage level within GCP/GLP function. track record of establishing more »

met. • Oversees and performs complex ǪA activities involving evaluating and reviewing processes to ensure manufacturing, testing and clinical trials activities comply with GMP, GCP, HTA and other regulatory requirements relating to manufacture and clinical trials for cellular therapies and AT(I)MPs including. • Identifies and communicates significant quality … Requirements • Extensive experience writing and reviewing GxP documents (including SOP’s, qualification/validation reports and batch records prior to ǪP review) to ensure good documentation, data integrity, essential GxP, quality and regulatory requirements are met. • Expert knowledge of GMP relating to sterile production, cleanrooms, aseptic technique, and hygienic more »

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over … Experience may be substituted for education. Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. more »

across PM. Support the development and validation of biomarker assays and Precision Medicine Solutions. Facilitate/participate in projects to deliver improvements to the clinical laboratory Quality Management System through collaboration with R&D Understand the business needs of PM departments, with respect to technology infrastructure, third party work … Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree Extensive R&D experience including experience in clinical development. Understanding of drug development and approval process and life cycle management Broad knowledge of technical platforms that include IHC, immunoassay, PCR, NGS … and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies) Experience in performing due diligence and auditing vendors for CDx test placement. Understanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations more »

in Europe & the only National Institute of Health Research (NIHR) Biomedical Research Centre (BRC) specialising in cancer. Our statisticians work under the Royal Marsden Clinical Trials Unit, and are exposed to the large, varied and innovative portfolio of studies ranging from early to late phase trials, and from simple … interventions. You will be involved in all aspects of study design, protocol development, database design, and statistical analysis. You will work in collaboration with clinical teams, and be given the opportunity to co-author conference abstracts and peer-reviewed journal papers, as well as attend internal and external courses … and Stata To gain/maintain knowledge of the EU directive on clinical trials (EU directive 2001/20/EC) and ICH GCP according to EU directive 2005/28/EC To gain a good knowledge of the clinical features, management and treatment of the more »

high quality research and ensure the best use of resources. The post holder will also work closely and collaboratively with senior colleagues within the Clinical Research Division (CRD), in particular the Research Governance Manager and Research Matron to support the effective setup and delivery of studies within the CRF … CRF performance data to determine trends and patterns and collate these data into reports. Responsible for the day-to-day running of the non-clinical aspects of the CRF, including facilities and information management. Taking into account the AHCRF objectives, Trust's overall strategy, Trust research strategy, develop and … Educated to masters level in a subject relevant to the role or equivalent relevant experience. Project management qualification or equivalent relevant experience. Desirable Valid GCP certificate Experience Essential Management within a clinical research environment. Working with clinicians and other health care professionals. Engaging with commercial and academic partners. Experience more »

Senior Project Clinical Data Manager We have the pleasure of working with a fantastic early phase CRO based in London. The company have a strong leadership team who are accelerating growth and have a great vision for the future. The offices are very modern and they have a fully … primary Data Management Lead for assigned projects ensuring clinical projects are carried out by the company in accordance with the executed contract, ICH GCP and other relevant regulations and guidelines and the customer’s expectations, taking responsibility for resourcing and planning of assigned projects. Provide hands on technical data … RFP) and Request for Information (RFI) process. Prepare input and participate in bid defence meetings Essential Degree or equivalent Knowledge of current regulatory regulations, GCP, ICH guidelines and Data-management industry standards SAS programming Detailed experience of end to end Clinical trial and Project Data Management processes, as well more »

Job Title: Head of/Director Quality Assurance (GCP) Location: Central London (4 days on site) Type: Full-time, Permanent A renowned organisation specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors seeks a dedicated Head of/Director Quality Assurance. Embracing a culture of excellence and … the development of transformative therapies. Responsibilities: Oversee quality assurance initiatives throughout the organisation, fostering a culture of continuous improvement to ensure compliance with ICH-GCP Guidelines and other regulatory standards. Identify and communicate observations or deviations encountered in day-to-day operations, actively participating in their resolution to maintain quality … Incident Reports (IRs) through the electronic Quality Management System (eQMS), driving continual quality enhancement. Review and approve Quality Documents to ensure adherence to ICH-GCP standards and process improvements, leveraging the eQMS. Prepare for and host external Sponsor audits or Inspections, facilitating timely provision of documentation and addressing findings through more »