13 Good Clinical Practice Jobs with Hybrid or WFH Options

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 »

have the right to work in this location. Key Responsibilities: For this role, you will assist with compliance on all GMP/GDP and GCP regulations guaranteeing adherence to GxP and data integrity legislation. Serve as the System Owner/Administrator role for GxP IT systems that reside within QA. 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 »

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 »

Overview The Clinical Data Lead holds a pivotal role within a Series A healthtech/clinical trials company, requiring a candidate with a medical background. They will spearhead the establishment and management of crucial clinical data contracts with hospitals, both domestically and internationally, while also overseeing agreements … with CRO and biopharma partners during clinical trial operations. Supported by a team of data engineers, this role involves collaboration across various teams and direct reporting to the CEO. Responsibilities Lead the development and maintenance of clinical data contracts with NHS hospitals and global partners. Oversee data contract … applicants only. Full right to work in the UK without restrictions or sponsorship. Medical degree and a minimum of 2 years of NHS experience. GCP trained. Willingness to commute to the Cambridge or London office at least one day per week. Experience in data security policy, data retention policy, and 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 »

past history: 1. Relevant degree in a relevant life sciences discipline 2. Proven industry experience working in a GMP environment (preferred), or , GLP, GDP, GCP 3. A working knowledge and practical experience with document/Quality Management Systems, and Electronic Document Management Systems Key Words: QA | Quality Assurance | QMS | Quality … Management Systems | Clinical | GMP | GxP | Biotechnology | QDM | Quality Document Management Systems | Electronic Document Management Systems | Drug Discovery | CAPA | Deviations 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 »

Job Title: Project Specialist 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 and discover the … level documents within internal OneDrive or SharePoint. Assist with collecting and reviewing project documentation from investigational sites, ensuring it meets EMA/MHRA/GCP/ICH requirements. Prepare Investigational Product Review Forms (IPRFs) and submit them to WEP Clinical Regulatory team. Support preparation of study files based on 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 »

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 »

/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 »