7 Good Clinical Practice Jobs in the East of England

Career Category Clinical Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s … delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us. CLINICAL DATA MANAGEMENT MANAGER LIVE What you will do In this vital role you will responsible for ensuring clinical projects are executed according to … study level non-DM documents for awareness and project level consistency. Lead electronic submission activities and assist with response to questions and findings from Clinical Quality Assurance (Quality Assurance) and other audits at the study/vendor level. Lead or participate in the development, review and implementation of processes 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 »

interventional studies under your supervision according to agreed resources, budget and timelines complying with AstraZeneca Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. You will accountable for the performance of the Oncology sites selected; ensure that Oncology study sites are identified, qualified … assigned to the clinical trials. You will oversee the budgets and timelines and support implementation using local relevant local regulations and international ICH-GCP guidelines. As the SMM Oncology Lead, you will be part of the Oncology SMM Leadership Team and line manage a dedicated group(s) of staff. … for national and international travel. Desirable for the role Very good knowledge of the Clinical Study Process, Procedural Documents and international ICH-GCP guidelines. Excellent knowledge of the Monitoring Process. Good understanding of the Study Drug Handling Process and the Data Management Process. Good knowledge of 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 »

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 »

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 »