16 Good Clinical Practice Jobs with Hybrid or WFH Options

/life balance. What we are looking for Life science degree. Extensive auditing experience in GCP. Thorough knowledge of GCP. Able to confidently audit GCP Vendors or Investigator Sites with limited oversight. Strong client focus. What You’ll Do With Us Focusing on delivering top-class audits to our list 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 »

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 »

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 »

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 »

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 »

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 »

Job SummaryMedpace is currently seeking an office or home based Director of Proposals to join our Clinical Operations team at our London office. The Director will collaborate closely with our medical experts and senior functional managers to create the operational strategy for new business development opportunities. This will include … assigned.QualificationsBachelor's degree minimum, advanced degree preferred;Highly-proficient employee with strong leadership, writing and problem solving skills;5+ years of project management/clinical trial management experience in clinical research; CRO experience preferred;Must possess superior time management, planning and organizational … skills, written and verbal communication skills, and quality decision-making skills;Advanced knowledge of drug development, clinical trial management and operational procedures, including GCP guidelines; andDemonstrated ability to effectively interact face-to-face with Sponsors and represent company in outside settings. Medpace OverviewMedpace is a full-service clinical more »

a growing ecosystem of drug development companies, that provide integrated and specialist operational support for rapidly scaling biotech ventures. They are looking for a GCP QA Manager who will work closely with the Head of Quality and Clinical Teams to advise and oversee GCP compliance in accordance with local … and international quality standards. The role will include review and approval of GCP quality documents such as SOPs, Policies, Forms, and other key essential documents supporting clinical trials. This is a 6M day rate opportunity with hybrid working based near Oxford. The expectation to be on site is more »

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 »

Clinical Data Manager – £35,000-£47,000 per annum– Liverpool/Hybrid The Role Do you have a keen eye for detail and a knack for ensuring data accuracy? Are you excited about using cutting-edge AI to transform healthcare? MyCardium AI, a rapidly growing company using AI to … revolutionise cardiac MRI analysis, is seeking a highly motivated Clinical Data Manager to join our team in Liverpool. In this pivotal role, you will oversee the collection, management, and analysis of imaging data from clinical trials. You'll ensure data quality and integrity, working closely with a dynamic … clinical data management, ideally in imaging. Experience with imaging data and software (PACS, DICOM). Knowledge of Good Clinical Practice (GCP) and regulatory guidelines. Proficiency in data management software and databases. Strong understanding of clinical trials and regulations. Excellent organisation and communication skills. Ability to 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 »

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 »

that we offer, and the successful applicant will work with the Research Governance group to continue to develop our research programme and with the clinical teams on service development and data management projects. Main duties of the job Be a professional role model and research champion for the organisation. … Team: Hospice Care Team Group: Care Reports to: Nurse Consultant Paediatric Palliative Care Hours: 37.5 hours (Split between Specialist PalliAtive CarE (SPACE) team and Practice Education team) 3 days within the hospice, 2 days remote working Level: Band 7 £50,921.91 - £55,184.02 (geographical allowance included) Location: Christophers, Guildford … the successful applicant will be required to work with the Research Governance group to continue to develop our research programme, strategy and with the clinical teams service development and data management projects. This role is able to be offered as a hybrid working pattern with 3 days in the 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 »