their research centre to contribute to their compliance by assuring that their clinical trial activities comply with goodclinicalpractice (GCP) regulations and guidelines for laboratories. You will work alongside multidisciplinary laboratory and support teams and contribute to maintaining and assuring that their Quality Management System … regulations, standards, and procedures. You will have the opportunity to work closely with personnel at all levels of the organisation to assure their regulated GCP activities meet the required standards. As the Scientific Officer you will possess experience in a quality assurance or compliance role within a GxP regulated laboratory … with knowledge of GCP regulations, internal audits, non-conformance (or deviation) and CAPA management. Ideally you will have experience with LIMS and QPulse. You will possess BSc (or equivalent) in Science or a related subject or have equivalent relevant experience. Duties include: Using a range of Quality Management System procedures More ❯
UCLH (University College London Hospitals NHS Foundation Trust)
and Development Grade: NHS AfC: Band 4 Contract: Permanent Hours: Full time - 37.5 hours per week Job ref: 309-UCLH-5888 Site: NIHR UCLH Clinical Research Facility Town: London Salary: £31,944 - £34,937 Per annum inclusive of HCAS Salary period: Yearly Closing: 20/02/:59 The … studies. The post holder will ensure high quality data in line with the study protocol, the principles of GoodClinicalPractice (GCP) and the UK Medicines for Human Use (Clinical Trials) Regulations. The post holder will be based across both CRF sites according to the needs … equivalent, with Grade C or above in English and Maths. Knowledge of drug development process and concept of clinical trials Knowledge of ICH GCP Science related degree or equivalent Experience Experience of dealing with confidential information Experience of working with clinical trials Skills & Abilities Ability to make decisions More ❯
Medical Writing, to drive efficiency and accountability. IQVIA Biostatistics helps interpret and draw inferences from data collected on patients as they progress through a clinical trial and serves as the bridge between data capture and reporting. We have one of the largest Biostatistics departments within the industry of around … needs analysis for complex project or client requirements. Acting as a lead on studies, you will directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines and support the training of new or junior team members. As well as … and coordinating tasks within a programming team In-depth knowledge of applicable clinical research regulatory requirements, i.e. GoodClinicalPractice (GCP) and International Conference on Harmonization (ICH) guidelines Join IQVIA to see where your skills can take you Global exposure Variety of therapeutic areas Collaborative and More ❯
Medical Writing, to drive efficiency and accountability. IQVIA Biostatistics helps interpret and draw inferences from data collected on patients as they progress through a clinical trial and serves as the bridge between data capture and reporting. We have one of the largest Biostatistics departments within the industry of around … needs analysis for complex project or client requirements. Acting as a lead on studies, you will directly communicate with internal and client statisticians and clinical team members to ensure appropriate understanding of requirements and project timelines and support the training of new or junior team members. You will estimate … and coordinating tasks within a programming team In-depth knowledge of applicable clinical research regulatory requirements, i.e. GoodClinicalPractice (GCP) and International Conference on Harmonization (ICH) guidelines Join IQVIA to see where your skills can take you Global exposure Variety of therapeutic areas Collaborative and More ❯
a permanent, full-time role. The successful candidate will work within our Quality team supporting the implementation of our next generation patient-centric remote clinical trial solutions. What will you do? You will be an integral part of our Quality team responsible for ensuring that the development and configuration … teams to facilitate the compliant release of core, and configured software to support the capture and processing of patient and clinician data relating to clinical trials that are performed by our customers. Core components of the role will include: Acting as a quality contact/subject matter expert for … need to succeed ESSENTIAL SKILLS AND COMPETENCIES A bachelor's degree or equivalent in a science subject Knowledge of Quality System rules, regulations and practice associated with the development of software systems that are used in regulated life-sciences industries Demonstrable competency in the methods used to validate software More ❯
Royston, Hertfordshire, South East, United Kingdom
Intertek
the appropriate standards and effective working systems and relationships are maintained and where necessary improved and completely reflect the raw data and meet current GoodClinicalPractice standards and regulations Identify and contribute to areas for improvement within the quality management systems to ensure compliant and efficient More ❯
review and approve CSV strategies/plans, devise compliance maturity assessments and remediation plans. Responsibilities Business Relationship: Collaborate with Quality Assurance Quality Systems, and Clinical QA Organizations to ensure that IT CSV and GxP processes and related procedures are in alignment with Quality/Regulatory Policies and SOPs. Collaborate More ❯
your dream job, you'll also be helping to save the planet! THE ROLE We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Excellent … to company resourcing meeting Point of contact for programming issues for the team, proactively ensuring everything is working cohesively Persuade stakeholders to follow best practice within a trial Develop and deliver company-wide training as and when required Identify areas where new processes are required Create, review and update … the pharmaceutical industry Good awareness of clinical trial issues, design, and implementation Experience of regulatory submissions and associated industry guidance Familiarity with GCP and regulatory requirements Knowledge of SDTM and ADaM CDISC standards APPLY NOW With the world's eyes focused on clinical trial data, this is More ❯
dream job, but you'll also be helping to save the planet! The Role We are seeking a Senior Programmer to work across multiple clinical and non-clinical studies; supporting regulatory submission activities; producing and validating datasets and outputs to excellent quality while adhering to deliverable timelines. The … the pharmaceutical industry. Good awareness of clinical trial issues, design, and implementation. Experience with regulatory submissions and associated industry guidance. Familiarity with GCP and regulatory requirements. Knowledge of SDTM and ADaM CDISC standards. Apply Now With the world's focus on clinical trial data, this is a More ❯
our clients' cutting-edge research, helping innovative biopharmaceuticals, monoclonal antibodies, biomarkers and immuno-oncology treatments gain regulatory approval. We are a niche GLP and GCP compliant laboratory with our experienced scientific team providing specialist immunohistochemistry (IHC), histology, digital pathology and image analysis solutions, working with pharmaceutical and biotechnology companies worldwide. More ❯
PowerPoint) and adaptable to new software packages/web applications. Experience in developing and delivering end user training, preferred system training. Excellent interpersonal skills. Good organisational and time management skills and able to demonstrate flexibility and adaptability. Experience working with high volumes of documentation, electronic and paper. Good attention to detail for data entry tasks and understanding of Good Documentation Practices. A basic understanding of … computer system validation in the pharmaceutical sector. Experience and knowledge of working in a regulated environment, specifically with regards to record retention. Knowledge of GCP and GMP with regards to QMS activities. Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP More ❯
deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: People Leader All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: Our expertise in Innovative Medicine is informed … NJ; Springhouse, PA; or Titusville, NJ. Purpose: The adoption of risk-based methodologies and analytics is a key area of innovation and growth in Clinical Trial Data Management, Central Monitoring and Global Clinical Operations. Responsibilities: Accountable for the strategy, planning, and execution of departmental goals within assigned area … track record working successfully in a complex multi-functional environment collaborating with partners, customers, and external vendors. Expert knowledge of regulatory guidelines (e.g., ICH-GCP) and clinical R&D concepts. Applied understanding of project management concepts, sourcing strategies and resource management. Proven experience in process development and improvement and More ❯
off through to study close. Collaborate with customers to exceed their expectations of project outcomes. Create both customer configuration speciation from customer protocol and clinical case record forms. Ensure the quality of all customer-facing deliverables. Manage all project documentation according to defined processes. Identifies risk areas and determines … succinctly. WHAT YOU NEED TO SUCCEED Industry Experience: A demonstrable track record of project management achievements in eCOA/ePRO or EDC industries. Extensive clinical trial experience for either medical device or pharmaceuticals. Team and Project Management: Confidence working within a project management position in a client-facing role … trial process and an understand of application design and development processes. Experience working within regulated environments, for example GDPR (General Data Protection Regulation), GCP & HIPAA. Nice to have: PMP Certification Proven experience of delivering eClinical technology for clinical research. Experience in process improvement. UMOTIF IS AN EQUAL OPPORTUNITY More ❯
Data Management activities using advanced data management tools and techniques with respect to cost, quality, and timelines for all assigned trials/projects within Clinical Data Acquisition and Management. The position is a key collaborator and strategic partner with stakeholders ensuring that data management activities for the clinical trials are executed efficiently with timely and high-quality deliverables (in alignment with the Novartis Clinical Data Quality Statement). This role reports to the Director of Data Management. About the Role Key Responsibilities: Lead data management activities as Trial Clinical Data Scientist for complex priority trial … Strong leadership, collaboration, and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines. Excellent understanding of clinical trials methodology, GCP, and medical terminology. Proven ability to interrogate and view data through various programming/GUI techniques. Must be able to anticipate challenges and risks and More ❯
off through to study close. Collaborate with customers to exceed their expectations of project outcomes. Create both customer configuration specifications from customer protocol and clinical case record forms. Ensure the quality of all customer-facing deliverables. Manage all project documentation according to defined processes. Identify risk areas and determine … succinctly. What you need to succeed Industry Experience A demonstrable track record of project management achievements in eCOA/ePRO or EDC industries. Extensive clinical trial experience for either medical devices or pharmaceuticals. Team and Project Management Confidence working within a project management position in a client-facing role … trial process and an understanding of application design and development processes. Experience working within regulated environments, for example, GDPR (General Data Protection Regulation), GCP & HIPAA. Nice to have PMP Certification Proven experience of delivering eClinical technology for clinical research. Experience in process improvement. Why uMotif? Unlimited paid holiday More ❯
Product Manager - Health Tech Company Join Us in Revolutionising Healthcare! Are you passionate about leveraging technology for the greater good? Here's your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey … experience in healthcare technology Working knowledge of healthcare data standards, particularly FHIR Product analytics, UI/UX feedback loops, and process optimization Experience with clinical workflows and healthcare IT systems Strong analytical and problem-solving skills Excellent communication and stakeholder management abilities Bachelor's degree in a relevant field … based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and offer a competitive More ❯
Oxfordshire, Oxford, South East Hybrid / WFH Options
Computer Futures
Product Manager - Health Tech Company Join Us in Revolutionising Healthcare! Are you passionate about leveraging technology for the greater good? Here's your chance to make a tangible impact on global health! This cutting-edge Health Tech Company is at the forefront of innovation. Be part of the journey … experience in healthcare technology Working knowledge of healthcare data standards, particularly FHIR Product analytics, UI/UX feedback loops, and process optimization Experience with clinical workflows and healthcare IT systems Strong analytical and problem-solving skills Excellent communication and stakeholder management abilities Bachelor's degree in a relevant field … based data exchange, data mapping, and validation rules Experience with clinical research or EDC systems Knowledge of regulatory requirements for clinical trials (GCP, 21 CFR Part 11) Familiarity with Agile development methodologies What's On Offer Competitive Salary and Benefits: We value our team and offer a competitive More ❯
are seeking a motivated and detail-oriented Life Sciences Data Analyst, with 1–2 years of professional experience within the life sciences, CRO, or Clinical trials sector, who is looking to further their career within life sciences data analytics and healthcare sector. The successful candidate will be responsible for … sciences discipline such as biology, biochemistry, or biomedical sciences Experience with in the clinical, Life sciences or CRO sector and an understanding of GCP Experience with statistical methodologies, bioinformatics, and data analytics Experience with R or Python Experience with data visualisation tools (ideally Keynote) Ability to communicate insights to More ❯
are seeking a motivated and detail-oriented Life Sciences Data Analyst, with 1–2 years of professional experience within the life sciences, CRO, or Clinical trials sector, who is looking to further their career within life sciences data analytics and healthcare sector. The successful candidate will be responsible for … sciences discipline such as biology, biochemistry, or biomedical sciences Experience with in the clinical, Life sciences or CRO sector and an understanding of GCP Experience with statistical methodologies, bioinformatics, and data analytics Experience with R or Python Experience with data visualisation tools (ideally Keynote) Ability to communicate insights to More ❯