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 »
Cambridge, England, United Kingdom Hybrid / WFH Options
Oho Group Ltd
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 »
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 »
Within pharmacy we have a position for a senior assistant technical officer. We are looking for an enthusiastic person to join our small pharmacy clinical trials team. We are responsible for ensuring that all the pharmacy and medicine aspects of clinical trials for cancers are conducted according to … daily basis providing feedback to relevant individuals as necessary. Management of IMP stock levels to include ordering, receiving, relabelling, archiving, according to Sponsor and GCP requirements To undertake routine expiry date checks and maintain the expiry date database. Arrange and act as a pharmacy representative at trial monitoring and close … field telephone calls and enquiries as appropriate. Person Specification Qualifications Essential NVQ 3/equivalent GCSE or equivalent passes in Maths, English and Science GCP training within last 2 years Desirable Excel and use of Microsoft office programmes Experience Essential Experience of using a variety of IT packages to include more »
Job DescriptionHead of Clinical Data - Cambridge/London - Exciting MedTech Start … Up 🚀📢 Permanent + Tech-for-Good + Share options schemeDo 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 … start-up which aims to combine technology and medicine to improve the lives of patients who are dealing with complex diseases by using clinical data and Machine Learning technology. You’d be responsible for the data contracts that the company has with their partners as they run clinicalmore »
projects ensuring efficient project management, compliance, and high-quality deliverables. You will have the chance to contribute to improving healthcare through medicine by analysing clinical trial data, providing statistical consultancy, and mentoring junior colleagues. Please note that to be considered for this role you must have the right to … Responsibilities Apply innovative statistical approaches to solve novel data challenges. Lead projects, ensuring efficient project management, compliance, and high-quality deliverables. Analyse phase III clinical trial data to support HTA submissions. Provide statistical consultancy to internal and external customers. Plan, analyse, and visualise observational and real-world data. Support … equivalent knowledge/expertise. 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 more »
Assurance department. - Knowledge of GxP and Quality related regulations and standards within the Pharmaceutical/Medical Device industry. - Familiarity with ISO 9001, ISO 13485, GCP is essential. - Knowledge of ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor would be beneficial. Interested or know someone who might 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 »
bioanalytical study or other plans Team player Review and sign of study data Responsible for regulatory compliance as assigned Ensure all processes are following GCP/GLP Liaising with clients regarding within agreed timescales Qualifications At least 3 years experience working in a regulatory bioanalytical laboratory. A degree in life … sciences or chemistry-related subject A good communicator with strong interpersonal skills. Experience working within a GLP/GCP accredited facility. Flexible and adaptable with an eye for detail Hand-on experience of LC-MS/MS, Sciex and Waters LC-MS/MS systems is an advantage Experience more »
University Hospitals Bristol and Weston NHS Foundation Trust (UHBW)
Job summary Band 3 Clerical Officer (Clinical Trial Assistant) - Clinical Trials Unit, Bristol Haematology & Oncology centre Full time 37.5 hours. Permanent position. We are looking for an enthusiastic and motivated person to join our team within the Clinical Trials Unit at the Bristol Haematology & Oncology Centre. You … range of clerical and administrative duties as part of this post. Previous clerical and administrative experience is essential, along with excellent organisational skills and good literacy and numeracy. You will be I.T. proficient in a number of packages such as MS Word, Excel and Outlook and willing to learn … including cancellation of clinics and alteration of appointment slots as and when required and under supervision of the Administration Team Requesting CV's and GCP certificates, as well as PI oversight where applicable, from Research Personnel on an on-going basis and keeping an up to date record of documents 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 »
duties of the job Working autonomously, under the direction of the relevant research team leader, the post holder will collate data produced by the clinical teams and enter appropriately into paper or electronic case report forms (CRFs). In addition, the … post holder will liaise with trial sponsors to ensure timely transfer of data, and resolving any data queries, working within the guidelines of ICH GCP and local SOPs at all times. Other responsibilities will include assisting with the creation and maintenance of Investigator site files and databases of clinical … Values Education & professional Qualifications Essential oScience related degree or equivalent oKnowledge of drug development process and concept of clinical trials oKnowledge of ICH GCP Experience Essential oExperience of working under minimal supervision oExperience of working as part of a team oExperience of working to deadlines oComputer literacy to include more »
Hobson Prior is seeking a Biomarker Scientist to support clinical transcriptomics outsourced activities. The successful candidate will be responsible for conducting and supporting sample analysis, quality control, data interpretation, and reporting. This role requires staying updated with new and emerging techniques in the transcriptomics and biomarker fields. Please note … considered for this role you must have the right to work in this location. Key Responsibilities Act as a Subject Matter Expert in supporting clinical transcriptomics outsourced activities from planning and technical perspectives. Ensure timely delivery of high-quality, fit-for-purpose assays and robust data. Conduct and support … Experience of working with human tissue under the directives of the Human Tissue Act (HTA), and experience of working with samples and studies under GCP compliance. Practical experience in any of the following techniques would be an advantage: histology and immunohistochemistry, Immunoassay and ligand binding assays, Flow cytometry assays, LC more »