1 to 25 of 59 Good Clinical Practice Jobs

Background must be in pharma NOT medical devices) Senior R&D QA GCP Auditor (pharmaceuticals) I'm looking to recruit a seasoned Senior R&D QA GCP Auditor responsible for ensuring compliance and proper implementation of Good Clinical Practice (GCP) and Good Clinical Laboratory Practice … the clinical development of Global R&D projects in the UK and EU settings. The ideal candidate should possess substantial experience as a GCP-GCLP auditor in pharmaceutical firms or Contract Research Organisations (CROs), as well as relevant experience in managing clinical trials involving investigational medicinal products as … managing audit results (non-conformities). the Unit Head's responsibilities in gathering data to aid in the annual audit program's preparation for GCP and GCLP auditing activities. in keeping the yearly audit programme for GCP and GCLP auditing operations updated and monitored. pertaining to GCP-GCLP auditing operations more »

Job Title: Project Coordinator Department: Project Management Company: WEP Clinical Location: Hybrid - Chiswick Tower, London, England Do you dream of being part of a team that brings hope to those who need it most? Are you searching for a career that challenges you and allows you to grow as … a professional? At WEP Clinical, we are expanding, and the opportunities for personal and professional development are endless. Our team is committed to providing patients with early access to life-changing medicine every day. We encourage our team to bring their most creative and innovative ideas. Join us today … ensure projects are completed in accordance with client expectations. Assist with project documentation collection and review from investigational sites, ensuring they meet FDA/GCP/ICH requirements. Support preparation of study files based on project scope including maintenance of internal or external document storage systems including Electronic Trial Master more »

Head of Clinical Data - Cambridge/London - Exciting MedTech Start-Up … Permanent + Tech-for-Good + Share options scheme Do you have a strong interest in the HealthTech and MedTech industry? Are you GCP trained with a Medical Degree and experience working in NHS? We’re looking for a Head of Clinical Data to join this exciting MedTech … universities Experience working in the NHS Experience working with data policies and GDPR Experience working with medical data contracts such as EHR and PACs GCP trained Great problem-solving abilities Excellent time management and communication skills What’s in it for you 💰: Competitive starting salary Share options scheme Hybrid working 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 »

The focus of this role is leading a team of scientists to deliver development, validation and sample analysis projects within Immunoassay. You will build close relationships with a number of our customers and be responsible for delivering high quality results 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 »

plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and continuously improving the site's … Qualifications Bachelor’s degree (preferred) 3+ years of experience in a laboratory, pharmaceutical, medical device, or clinical research organization (required) Demonstrated experience in GCP, ISO15189, NEQAS, CAP, CLIA (strongly preferred) Certified Quality Auditor (preferred) RESPONSIBILITIES Quality Assurance Responsibilities: Ensure the efficiency of the Quality System/personnel for the … Act as Deputy Archivist, responsible for maintaining the archive and its contents in compliance with relevant regulations. Introduce systems to comply with revised GLP, GCP, EMA, FDA, and OECD guidelines or regulations. Provide support/host customer-initiated audits, mock regulatory inspections, and regulatory facility inspections. Participate in the review more »

Associate Director Quality Assurance SUMMARY: The Associate Director, Quality Assurance is tasked with implementing strategies to ensure successful delivery of high-quality Clinical Trials studies. This involves driving effective and efficient global processes within the realm of Quality and Operations. This leader collaborates closely with the Clinical Trials … Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) strongly preferred. RESPONSIBILITIES: Leadership. Strategic partnership with Global Quality Assurance team and Global Leadership Team Regional oversight of Quality Assurance teams Daily management activities for … Maintenance of a working knowledge of industry and regulatory standards and requirements Provision of guidance and leadership on Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, data privacy, and other relevant regulatory standards Responsive escalation point for Clinical Trials quality issues and 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 »

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 »

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 »

well established QA function. KEY RESPONSIBILITIES: Coordinating the implementation of the company's quality management system pertaining to Good Clinical Practice (GCP), including oversight of external vendors, training on quality procedures, and performance monitoring against established standards. Serving as the main point of contact and providing support … Supporting the planning and execution of audits, including those conducted internally, at vendor sites, clinical sites, external laboratories, and suppliers. Providing guidance on GCP/GCLP/GLP practices to clinical project teams and identifying/mitigating operational risks and deviations. Overseeing Change Controls, Deviations, and Corrective and … any findings. Delivering training to laboratory teams as needed. Experience Needed: Minimum 4+ years of experience in the pharmaceutical/biotechnology industry in a GCP QA role, with experience in providing quality support to clinical laboratories. Experience in providing quality support for Cell or Gene Therapy programs is highly more »

debilitating disease areas. Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. Job Purpose Lead all Clinical Data Management (CDM) lifecycle activities from protocol inception to database delivery for numerous global studies via oversight of multiple vendors and internal/external … database locks. Participates in Service Provider selection, evaluation and management, including reviewing and providing input to scope of work. Coordinates user acceptance testing for clinical databases. Contributes to global and sub functional working groups and initiatives. Responsibilities Responsible for delivery of clinical global study databases and specific study … is an essential part of the position Working as the sole Data Manager within the Team Key skills and experience In depth knowledge of GCP and current legislation. Working knowledge of Medidata Rave ( desirable but not essential) and IBM databases Experience of delivering global clinical studies across different phases more »

role: Applying innovative statistical approaches to solve novel data challenges Leading projects, ensuring efficient project management, compliance, and high-quality deliverables Analysing phase III clinical trial data in order to support HTA submissions Providing statistical consultancy to internal and external customers Planning, analysing, and visualising observational and real-world … with proven industrial experience Knowledge of HTA-related statistical methods, including ITC, NMA, and complex statistical modelling techniques Awareness of regulatory standards, ICH/GCP guidelines, and HTA regulations Understanding of the clinical drug development process Proficiency in statistical programming languages (SAS and/or R) Strong problem-solving more »

progress research to improve patient care? We are looking for a hard-working, enthusiastic pharmacist who shares our Trust values to join our expanding clinical trials and research team at Mersey Care NHS Foundation Trust. Mersey Care is at the forefront of clinical trials for mental health, putting … of pharmacist as required3.Participation in screening, dispensing and checking of clinical trial prescriptions, and advising others of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and requirements relating to Investigational Medicinal Product (IMP) management.4.To participate in the Trust-wide Out of Hours Medicines Advice … in Clinical Pharmacy, willingness to work towards or equivalent experience Registration with General Pharmaceutical Council Desirable Membership of the Royal Pharmaceutical Society (RPS) GCP training Knowledge/Experience Essential Demonstrable evidence of commitment to self development and CPD Experience of undertaking audit within pharmaceutical services Understanding of how medicines more »

Sponsors to provide safe and efficient delivery of studies. Working with the unit teams and medical leads to create and maintain a culture of clinical excellence, process improvement, effective leadership and high standards of volunteer/patient care. KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED: A minimum of 4 years … experience working within a Senior Strategic Management role, along with a good understanding of Clinical Operations. A minimum of 7 years’ experience within the field of clinical trials, Early Phase preferred, or relevant clinical setting RGN/RMN or BSc Nursing/Biomedical or BSc … in a scientific field would be highly desirable RESPONSIBILITIES: Departmental operational oversight of business activities at the Early Phase Unit in accordance with ICH-GCP, MHRA Phase 1 Accreditation, MAC SOPs and Study specific protocols whilst optimising profitability by leading the MAC teams to meet/exceed business projections. Lead 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 »

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 »

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 »

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 »

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 »

experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth. I am working with a Clinical stage biotech company that are pioneering the development of regenerative medicines. There is a pipeline of several ATMPs that are at the forefront of … clinical medicine for ocular diseases. They are looking for a QA Manager, you will be responsible for providing QA Support to manufacturing operations. … Are you a QA Manager that has experience Performing QA Duties to ensure manufacturing, testing and clinical trial activities that comply with GMP, GCP and other regulatory guidelines Document Control systems Change Controls CAPA - Corrective and Preventative actions Deviations & OOS reporting Compliant and recall handling Performing internal Audits Write more »

research facilitators who will take responsibility for the smooth set-up of research across the trust. The role forms an essential bridge between investigators, clinical teams and funders, building accurate and comprehensive grant application costings and working through timely study set-up and delivery. This role will ensure the … largest acute teaching Trusts in England, we offer learning and development opportunities to help you achieve the career you aspire to. UHS is rated 'Good' by the CQC and in the latest national NHS Staff Survey, we were in the top 10 acute trusts for staff engagement and for … of the set-up or delivery of clinical research in a healthcare setting. Experience of delivery training Evidence of current and on-going GCP training Project management experience Knowledge of research governance and quality assurance systems to ensure safe systems for patients An understanding of current R&D issues more »

of Quality Assurance is to promote a quality culture of continuous improvement to ensure all systems and procedures undertaken are in compliance with ICH-GCP guidelines and other regulatory requirements. Main Responsibilities Ensure Non-Conformances/Incident Reports are reviewed, assessed and approved using the eQMS ensuring it is contributing … to continual quality improvement. Ensure Quality Documents are reviewed for process improvements, are of a high standard in accordance with ICH-GCP, and approved using the eQMS. Ensure external Sponsor audits or Inspections are prepared, hosted including timely provision of document requests, and for any findings CAPAs are raised, reviewed … necessary. Organising QA training for all staff - including distributing workload and monitoring task completion. Qualifications and Experience: At least 6 years of experience in GCP Quality Assurance within the Pharmaceutical Industry. Strong knowledge of Quality Management Systems within the Pharmaceutical industry. Strong knowledge of ICH-GCP and GMP guidelines. Experience more »