16 to 40 of 60 Good Clinical Practice Jobs

Quality Assurance Manager - Good Clinical Practice Our client, based in Cheshire are recruiting for a contract GCP QA Manager to join them for a 6 month project. This is an exciting opportunity to join a dynamic company with a great culture. Role: Provide strategic direction for quality … CAPA Process to ensure effectiveness Support the development of a risk based audit programme Maintain network of external audit providers to support CMC, pre-clinical and clinical activities. Support the management, implementation, and maintenance of the Quality Management System to support clinical development … activities. Support senior management in providing direction and leadership to staff to ensure a quality mindset is embedded in the business Requirements: Expert in GCP with working knowledge of GMP 5 years experience in a QA Manager role within a CRO, Biotech or Pharma company Contract: Hours: 3 days a more »

coordination all clinical trial functions within aseptic services to meet the needs of the service. Ensure compliance to procedures and national standards (GMP, GCP and The Medicines for Human Use (Clinical Trials) Regulations 2004). About us Cardiff and Vale University Health Board is one of the largest … communication and interaction skills. NVQ L3/BTEC Pharmacy services Good working knowledge of safe dispensing and aseptic practices Knowledge and understanding of GCP/GMP legislation and QA and its application to aseptic processing Able to demonstrate excellent organisational skills Good attention to detail and responsible attitude … quality and accuracy Experience in Clinical Trials day to day running of service, attending meetings, co-ordinating aspects related to organisation of trials GCP/GMP legislation (including preparation for inspection), clinical trial set-up and management, manufacture of IMPs and QP release, clinical trials in specialist more »

Job summary The Cambridge Clinical Trials Unit - Cancer Theme (CCTU-CT) is hosted by Cambridge University Hospitals (CUH) NHS Foundation Trust, which includes Addenbrooke's Hospital and is part of the Cambridge Cancer Centre, a partnership between Cancer Research UK, CUH and the University of Cambridge. As the Cancer … Theme of the Cambridge Clinical Trials Unit,we areresponsible for working with investigators to design, set up, conduct, analyse and publish cancer research studies sponsored by Cambridge University Hospital NHS Foundation Trust. The CCTU-CT currently accommodates both early and late phase studies, many addressing or associated with translational … scientific end points. We are seeking a trials data manager to be part of the cancer clinical trials team, which is part of the accredited Cambridge Clinical Trials Unit, to contribute to cancer research. We are looking for candidates with previous data management experience within a research environment. more »

Job summary The expanding Division of Psychology & Psychological Therapies is seeking a clinical and or forensic Psychologist to join our expanding service which now incorporates the learning disability forensic support team in North Derbyshire 37.5 hours/week, negotiable This is an exciting post is seeking a clinical … Psychologists in the learning disability forensic team in North Derbyshire and other multi-disciplinary team and services. We are looking to recruit a registered clinical psychologist who will actively contribute to the service's progression and ongoing development. Main duties of the job The successful candidate must have an … working with adults with learning disabilities and/or autism and experience of service development. You will need to work flexibly both directly in clinical settings and through remote contact with clients, carers and colleagues. You will need to be able to meet the travel requirements of the post more »

Job summary An exciting opportunity has arisen for anenthusiastic and motivated band 4/5 pharmacy technicians to work as part of our pharmacy clinical trials team here at University Hospitals Southampton NHS Foundation Trust. Experience and knowledge of ICH good clinical … practice and being a current holder of ACPT accreditation would be an advantage but is not essential.These permanent posts require specialist training in GCP and IMP management. You will work as a Senior Technician in Clinical Trials Pharmacy and must be committed to providing the highest quality of … specialities. You will be responsible in setting up trials, ensuring that trials run smoothly; this will include accurate record keeping and drug accountability of clinical trials, reviewing protocol specific guidelines and liaising within a multi-disciplinary team. You will need to be able to multitask, possess excellent communication skills more »

Drug Applications [NDAs], Biologics License Applications [BLAs]), and responses to safety queries from third parties, such as regulatory agencies. May perform safety reviews of clinical trial protocols, Investigator’s Brochures, clinical study reports, informed consent forms, and other study related documents. Participates on Global Patient Safety (GLPS) teams … World Education & Experience BA/BS or advanced degree in life sciences or related field with some experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Or PharmD or PhD in a scientific field. Knowledge & Other Requirements Demonstrated ability to be a fast learner. … Knowledge of the drug development process and understanding of and appropriate application of principles, concepts, practices, and standards of Good Clinical Practices (GCP) and Good Pharmacovigilance (GVP). Strong interpersonal skills and understanding of team dynamics. Proven ability to work successfully in a team-oriented, highly-matrixed 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 »

Associate Director of GCP | Permanent | Hybrid - Oxford | Circa £95k We are currently working on a new Associate Director of Good Clinical Practice position at a super exciting pharmaceutical startup client based in Oxford. They are looking for someone to come and and be the right-hand person … deputising for them, sharing responsibility and leading the team when required. The ideal person will have strong QA and managerial experience within pharma and GCP, someone who is willing to be hands-on and into the detail expected when operating within a startup environment. Responsibilities: Ensuring GCP is maintained and … to senior leadership and represent QA in reporting What you will bring: Roughly 7+ years working in a leadership QA position Outstanding knowledge of GCP, TFA and FDA regulations Strong management skills A desire to be hands-on and into the thick of things Logistics: Salary of around more »

Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that … assessments, etc.) Other duties as needed. Maintain awareness of and ensure compliance with the Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) requirements, and Good Documentation Practices (GDP). Work in a professional manner with clients, team members and management. Excellent computer skills including Microsoft Word 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 »

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 »

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 »

ERP) systems, such as SAP. 3+ years of experience sourcing process execution. Experience in working in a regulated environment (e.g. GDPR, SOX, HIPAA, CLIA, GCP, and FDA). Knowledge of other European languages (French, German, Italian, Polish, Spanish) and/or Japanese. Our success relies on the experiences and perspectives 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 »

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 »

FTC, opportunity to go permanent) Our client a Biotechnology Research company are currently hiring for a Labware Developer who has preferably worked in a GCP, GXP environment. Requirements; Experience with LIMS SQL Skills Understand Lab Processes The client are looking to hold interview ASAP, please apply if this role would 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 »

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 »