Proclinical is seeking a dedicated individual for the role of Associate Director, Clinical Data Management. The successful candidate will be responsible for leading the team and overseeing the execution of clinical trials. Responsibilities: - Organise and conduct team meetings. - Foster team development and identify high-performance team members. - Collaborate … with the (Senior) Director Clinical Data Management on team development. - Provide guidance to project teams on the oversight and supervision of CRO/third party vendors and organize trainings as needed. - Act as a mentor for new team members. - Contribute to the development and review of portfolio documents (includes … Clinical Data Management with a focus on DM activities as a Lead and DM project management. - In-depth knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects. - Experience with Clinical Database Systems and processes. - Proven experience in resource planning. - A background in natural more »
Great Ormond Street Hospital for Children NHS Foundation Trust
in advanced therapies and this role will be required to lead and develop services to respond to the building body of work across new clinical trials and into licensed therapies. The manufacturing facilities at GOSH will be developing into new facilities and you will be key in developing and … of GMP across the MHRA-licensed pharmacy production service, the delivery of GDP in the MHRA-licensed pharmacy distribution service and the delivery of GCP related to pharmaceutical aspects of clinical trials. Working closely with the team in Gene and Cell Therapy this role will be part of a … reporting Horizon scanning Previous experience of clinical audit Ability to take initiative and lead on projects including change management Applications for Research grant GCP Experience of electronic hospital systems Skills and Abilities Essential Good organisation skills/time management Excellent priorisation skills Self Motivated Good interpersonal skills more »
implement comprehensive quality management strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g. FDA, EMA, etc.) and industry standards (e.g. GMP, GDP, GCP). Provide leadership and direction to the quality assurance and quality control teams, fostering a culture of quality excellence, accountability, and continuous improvement. Establish and more »
implement comprehensive quality management strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g., FDA, EMA, etc.) and industry standards (e.g., GMP, GDP, GCP). Provide leadership and direction to the quality assurance and quality control teams, fostering a culture of quality excellence, accountability, and continuous improvement. Establish and more »
Team. Experience as a BA - circa 5+ years to work independently. Experience with Veeva and other quality systems. Must understand GXP. Order of focus - GCP, GDP/GMP and then GLP. Extensive experience and knowledge in Quality Assurance in Pharma/biotech space to interact with stakeholders. Not a validation 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 »
Northwich, Cheshire, North West, United Kingdom Hybrid / WFH Options
Dechra
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 »
Senior Project Clinical Data Manager We have the pleasure of working with a fantastic early phase CRO based in London. The company have a strong leadership team who are accelerating growth and have a great vision for the future. The offices are very modern and they have a fully … primary Data Management Lead for assigned projects ensuring clinical projects are carried out by the company in accordance with the executed contract, ICH GCP and other relevant regulations and guidelines and the customer’s expectations, taking responsibility for resourcing and planning of assigned projects. Provide hands on technical data … RFP) and Request for Information (RFI) process. Prepare input and participate in bid defence meetings Essential Degree or equivalent Knowledge of current regulatory regulations, GCP, ICH guidelines and Data-management industry standards SAS programming Detailed experience of end to end Clinical trial and Project Data Management processes, as well more »
Proclinical is seeking a dedicated Manager of Global Trial Optimisation. This role involves overseeing the clinical development strategy, clinical study concepts and protocols as well as operational plans. The successful candidate will play a crucial part in maintaining relationships with external experts to facilitate a wide source of … to meet deadlines, effective use of time, and prioritization. - Ability to influence and negotiate across a wide range of collaborators. - Knowledge of ICH/GCP and regulatory guidelines/directives. - Advanced project management skills, cross-functional team leadership, and organizational skills. - A minimum of a Bachelor's degree and relevant … industry experience. - Direct experience managing global clinical trial operations, including experience developing protocols and key study documents. - Technical proficiency in trial management software and MS applications. Interested or know someone who might be? Reach out to Matthew Pike using the following: ✉️ m.pike@proclinical.com 📞 +44 207 4400 639 (5342) Apply 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 »
Trial Master File Expert Our client is a young innovative clinical stage Biotech company with a strong development pipeline, now have approval for a new position for a Trial Master File (TMF) Expert within the Clinical Development and Operations group. There is flexibility for this hire to work … Director of Clinical Development and Operations, this hire will manage TMFs, Sponsor Oversight File (SOF) and Archiving for all studies according to ICH-GCP and other regulatory requirements. This TMF Expert will work closely with Clinical Project Managers across Phase I-III trials, covering multiple responsibilities of outsourced … Science degree is preferred. 10+ years’ experience managing TMFs in Clinical Operations environment, in the pharmaceutical, biotech or CRO industry working ICH/GCP guidelines. Experience in both paper and electronic TMF, and familiarity with naming and filing conventions and the CDISC TMF Reference Model and applicable industry guidelines more »
City Of London, England, United Kingdom Hybrid / WFH Options
Proclinical Staffing
Proclinical is seeking a dedicated and experienced Senior GCP Quality Auditor. This role is an integral part of the growing global team, contributing to the development and enhancement of audit strategy. The successful candidate will be responsible for conducting and managing audit activities in line with regulatory requirements and company … processes/procedures. Skills and Requirements: Bachelor's degree in a scientific or health-related field. Lead auditor qualification/certification. Experience in conducting GCP audits. Knowledge of regulatory inspections related to GCP is advantageous. Ability to work independently without supervision. Interested or know someone who might be? Reach out more »
Device QA department Working knowledge, within Pharmaceutical/Medical Device business) of GxP and Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits more »
and costs are controlled and communicated to appropriate parties. What will you be doing? Communication: Critical review and documentation with external and internal regulatory, clinical, and marketing experts, including clinicians to determine an appropriate path for product development. Ability to communicate and critically review scientific ideas effectively in written … R&D developments. Regulatory Intelligence: Maintaining awareness of existing and new legislation/guidance relating to ensuring developments comply with GMP/GDP/GCP and GXP, HMR, MDD and MDR where applicable. Quality Policy: To maintain an awareness of, and compliance with the company Quality policy and objectives, and … R&D sample requests. The Person Life Science Graduate Related Experience BSc, MSc, or PhD (MBA desirable) Experience in a related field (e.g., manufacturing, clinical, regulatory or R&D). Specialist knowledge: Niche Generics. Why join us? As well as a fantastic, inclusive company culture, where employees are truly more »
Macclesfield, Cheshire, North West, United Kingdom
Russell Taylor Group Ltd
via literature searches. Providing an indication of any potential difficulties with bioanalytical methods and assisting with client calls and visits. Working to GLP/GCP and showing good documentation practice. The Person A successful candidate will have previous experience working in a regulatory bioanalysis lab with experience performing LC … experience of using LC-MS/MS. Previous experience of troubleshooting Have previous experience performing sample extraction techniques for biological analysis. Must be a good communicator with excellent interpersonal skills. Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this 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 … Fortrea is transforming drug and device development for partners and patients across the globe. Job overview: Provides strategic direction and oversight of Quality Assurance GCP Audit and Inspection operations and assures that audit program aligns with global RCQA strategies. Oversees external sponsor and inspectorate evaluations assuring follow up on trends … drive strategic business process improvement initiatives 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 »
Company description: QA Director Audit & Inspection GCP-CDCS 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 … process improvement initiatives What we offer: 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 »
inclusive of sample preparation, data acquisition and processing, and generation of development reports. ATTRIBUTES: A minimum of 3 years of study management experience in clinical and/or preclinical studies Strong background knowledge of … large molecule analysis in support of PK and PD studies. Experience working in a regulatory environment, managing studies that are compliant with GLP/GCP Experience in a client facing role with the ability to provide high level advice and guidance to clients Non-Smoker: due to the nature of 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 … programs. Position overview ProPharma are currently supporting one of the global leaders within the life-sciences sector as they require substantial support for their GCP auditing activities. At present, we are currently searching for a freelancer/contractor to work for them on a full-time basis (1.0FTE) remotely with … for 2025. Qualifications required Further education is required to at least a BSc level in a life science or related field Demonstrated background in GCP Quality/Auditing within the Pharmaceutical or Biological industry is a must Fluency in English is a must Ability to travel to sites within the 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 College London Hospitals NHS Foundation Trust
quality patient care. This post will also be committed to developing the research portfolio and enhancing the national and international profile of the service. Clinical work will be both outpatient-centred in the UCH Macmillan Cancer Centre and involve inpatient attending on a rotational basis. Participation in regional and … working closely with the CAR-T service alongside Dr Claire Roddie, Dr Maeve O'Reilly and Dr Paul Maciocia. There are 3 Cell Therapy clinical nurse specialists (CNS), 3 Lymphoma stem cell/CAR-T CNS and 10 ATIMP clinical trials nurse/practitioners. There is currently one … Participation in clinical audit and attendance at appropriate courses. Research Essential Familiarity with clinical trial methodology Evidence of research activity Evidence of GCP training Desirable Research in relevant clinical field Evidence of first authored publications/peer reviewed publications Disclosure and Barring Service Check This post is more »
Advanced Clinical is seeking a Global Senior Manager in Feasibility to work for a European-based Global Biotech specializing in Oncology. The Senior (Snr) Manager, Feasibility, will support early evaluations for proposed new studies originating within the Sponsor. The Senior Manager, Feasibility, will undertake evaluations to determine whether a … location of patient populations, local practices, considerations of protocol designs, Site ID, and risks. Cross-functional working (e.g. with real-world evidence team, GPSS, Clinical Monitoring team) to facilitate processes to support therapeutic landscape evaluations to assist in the selection of best countries/sites to ensure the necessary … in evaluating the study viability. Required/Preferred Education Extensive pharmaceutical or related industry experience, minimum 8-10 years industry experience. Excellent knowledge of GCP and regulations Experience of team management more »
Biotech companies, are hiring a Senior Statistician to join their growing team. The role Lead and manage customer projects ensuring high-quality deliverables Analyse clinical trial data and real-world data Support HTA submissions Mentor junior colleagues Requirements 2+ years’ experience as a Statistician Industry experience, ideally working in … in the UK without needing visa sponsorship. Keywords: HTA, health technology assessment, statistician, biostatistician, ITC, indirect treatment comparison, NMA, network meta-analysis, ICH/GCP, SAS programming, R programming more »
HQ 💰 Up to £95,000 per annum 🦸Tech for Good 📈 Seed Funded Startup with thousands of users 📱 Tech Stack: React Native, TypeScript, ReactJS, GCP Play a meaningful, Senior role in building a product from zero to one as this tech for good start up scales from one product … team to many.. Sound interesting?.. This could be for you! I am partnering with a "Tech for Good", seed funded startup with ambitious plans to provide a long term, sustainable solution for one of life's taboo challenges related to sexual wellbeing. The aim being to provide a … large scale, cross platform applications in React Native. The role also opportunities to work across the stack with technologies such as TypeScript, ReactJS and GCP within an agile environment. You'd be involved in the end to end design and greenfield development of a React Native application with a focus more »
