16 of 16 Good Clinical Practice Jobs in the South East

at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking an Associate Director, Clinical Data Management who can lead and oversee end to end Clinical Data Management activities on assigned studies and programs. You’ll also play a critical role in the … be responsible for leading and delivering initiatives for CDM within the Biometrics group. You’ll also be proactive and be keen to collaborate with cross functional groups within the Clinical Development organization and larger Data Science teams at Recursion. Daily, you will be responsible for all the CDM study activities and deliverables, document reviews, oversight of CRO’s, timelines … ability to manage outsourced studies and lead DM and external vendor oversight activities and deliverables.Proficiency in project management leading 3-4 outsourced programs, simultaneously. Represent Data Management function in Clinical Study Meetings, ensuring proactive alignment of expectations between the CRO and Recursion regarding all data-related deliverables. Work with CRO and Recursion functional groups to complete EDC set up More ❯

today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: Senior Manager Clinical Data Standards About Innovative Medicine Our expertise in Innovative … while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Senior Manager Clinical Data Standards, within Integrated Data Analytics & Reporting (IDAR), to guide the execution of projects, programs, and processes that span multiple related areas in support of the organisation's overall …/scientific experience in a related discipline; e.g., data management, biostatistics, clinical or statistical programming Minimum 5 years SDTM experience essential! Expert knowledge of relevant regulatory requirements (e.g., GCP, ICH) and industry standards (e.g., SDTM, ADaM) Demonstrated written and verbal communications skills Demonstrated customer focus and solution-oriented experience Demonstrated interpersonal skills to build relationships with internal and external More ❯

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Manager, Patient Recruitment & Retention to join our A-team (hybrid*/remote). As a Sr. Manager, Patient Recruitment & Retention at Allucent … PDT scope with other Allucent departments such as Biometrics, Project Management, Consultancy, GCO and study start-up. Leadership: Keeps oversight to ensure compliance to the SOPs and ICH/GCP/regulatory guidelines and best practices as well compliance to the department and project metrics. Where needed, initiates course of action to achieve/sustain compliance and efficiency. Contributes to … will possess: Life science, healthcare and/or business degree. Minimum 8 years of experience in drug development and/or clinical research. Excellent knowledge of ICH/GCP, FDA and country regulations. Strong customer service orientation. Demonstrated professionalism and presentation of a positive image of the company. Demonstrated understanding of applicable medical/therapeutic area knowledge and medical More ❯

at IQVIA Get AI-powered advice on this job and more exclusive features. The Risk-Based Quality Management (RBQM) Risk surveillance Lead is responsible driving the adoption of RBQM practice at trial level and oversee the implementation, and continuous improvement. Risk Surveillance … Lead works within a matrix environment and has overall accountability for the surveillance of the quality risks across the assigned trials and program, enabling a comprehensive clinical quality (GCP) risk governance. The role demonstrates leadership in influencing and improving clinical trial quality through the expert understanding of clinical trial protocols, processes, regulatory requirements, and quality management principles. … Based Quality Management Robust understanding of the drug development process and clinical trial execution Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP) Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions Knowledge of RBQM IT systems or other More ❯

The services hold a responsibility for implementation and maintenance of digital health systems supporting clinical development activities within the Global Development department. The incumbent will be required to provide subject matter expertise in system implementation, validation, maintenance and issue escalation. In addition, it includes participation in/lead operational strategy projects. The services require to work closely with other … team members to ensure system impact is assessed and mitigation strategies are in place where applicable. A clear understanding on the needs of clinical trials/programs and internal or external stakeholders. • Lead projects and/or workstreams actively engaging team members from start to closure • Use project management tools for lean execution of a project • Analyze and document … support system requirements • Interact with Business and obtain the Business Scenarios. General • Services rendered will adhere to applicable Client SOPs, WIs, policies, all applicable local laws and regulations, ICH-GCP, etc. • Comply with relevant training requirements. • Protect the rights of others; protect privacy and company assets, particularly information as the key asset. • Maintain adequate communication with relevant parties within and More ❯

week ago Be among the first 25 applicants The services hold a responsibility for implementation and maintenance of digital health systems supporting clinical development activities within the Global Development department. The incumbent will be required to provide subject matter expertise in system implementation, validation, maintenance and issue escalation. In addition, it includes participation in/lead operational strategy projects. … require to work closely with other team members to ensure system impact is assessed and mitigation strategies are in place where applicable. A clear understanding on the needs of clinical trials/programs and internal or external stakeholders. Lead projects and/or workstreams actively engaging team members from start to closure Use project management tools for lean execution … support system requirements Interact with Business and obtain the Business Scenarios. General Services rendered will adhere to applicable Client SOPs, WIs, policies, all applicable local laws and regulations, ICH-GCP, etc. Comply with relevant training requirements. Protect the rights of others; protect privacy and company assets, particularly information as the key asset. Maintain adequate communication with relevant parties within and More ❯

Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: People Leader All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom Job Description: We are recruiting for a Clinical Programming Portfolio Lead for our location in High Wycombe The Clinical Programming Portfolio Lead is a highly experienced individual with expert understanding of programming strategies, practices, methods, processes … and contribute to organizational effectiveness, transparency, and communication. Directly contributes to delivery of the J&J IM R&D portfolio through effective leadership and accountability of large or complex clinical development and strategic innovation of programs and projects. In collaboration with Senior departmental leadership, the Clinical Programming Portfolio Lead influences departmental effectiveness acting as a change agent to … years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes) and regulatory guidelines (e.g., ICH-GCP) Project, risk, and team management and an established track record leading teams to successful outcomes. Established track record collaborating with multi-functional teams in a matrix environment and partnering with More ❯

IDAR) organization. The Principal Engineer Digital Health Enablement is responsible for shaping the interfaces between partners, system and process for capabilities administered by Enabling Analytics & System Excellence EASE within Clinical Trial Management Solutions (CTM Solutions) or Investigator & Patient Solutions (I&PS). • The Principal Engineer Digital Health Enablement within CTM Solutions will oversee end to end system planning, administration … oversight and related processes for capabilities supporting clinical trial document management/TMF, study management and oversight. • The Principal Engineer Digital Health Enablement will oversee end to end system planning, administration, oversight and related processes for capabilities supporting patient engagement, site staff enablement, clinical staff training. This includes driving customer enablement and innovative solutions for the supported capabilities … leading inspection-ready practices for the supported capabilities, with a focus on delivering measurable value for stakeholders. • Lead change management efforts, promoting the adoption of new tools and ensuring clinical trial teams are well-equipped to use them effectively. • Remaining connected as a primary point of contact with stakeholders, functional area points of contact and subject matter expert frameworks. More ❯

full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Within Enabling Business Information Solutions (EBIS), the Clinical Trial Management Solutions business is recruiting for a Trial Master File (TMF) Analyst to join our Trial Master File (TMF) Center of Excellence (COE) team. The position may be … Qualifications Education and Experience Requirements Education : A bachelor’s degree is required, preferably in health, science, or information technology. Experience : At least 3 years in the pharmaceutical industry or clinical trials. Candidates should have strong technical expertise, with proficiency in electronic records systems (particularly eTMF), IT tools, data warehouses, and, ideally, database administration. Familiarity with emerging technologies such as … RPA), Machine Learning (ML), and Artificial Intelligence (AI) is a plus. An understanding of TMF content management, clinical trial conduct, drug development processes, and regulatory standards (ICH/GCP) is advantageous. Experience with audits, inspections, and implementing quality metrics to support decision-making is highly desirable. Good communication, problem-solving, and organizational skills are crucial, along with the More ❯

Fixed-term for 3 years in the first instance Hours: Full time About the role We have an exciting opportunity for a Senior Data Manager to join the Oncology Clinical Trials Office (OCTO). OCTO, part of the University of Oxford's Department of Oncology, is a leader in early cancer detection, precision prevention and therapy trials, delivering groundbreaking … clinical research. As the Senior Data Manager, you will be responsible for ensuring that data collection systems and data management activities are appropriately designed, implemented, maintained, or developed to support the collection of high-quality clinical trial data sets for analysis, publication, and, where appropriate, future data sharing. Data from multiple sources needs to be integrated in an … data management and information governance within clinical trials, including CTIMPs, in a sponsor organisation. You will have experience of implementing approaches to ensure compliance with high standards of GCP, the requirements of UK clinical trials and data protection legislation, and will have experience of developing and delivering training in relation to data management and integrity. You will have More ❯

providing aseptically prepared clinical trial doses for patients across different specialities within the Trust and maintaining up-to-date documentation according to Good Clinical Practice (GCP). The main role of this post is to supervise and manage the day-to-day service provided by CTASU and to ensure that aseptic preparation of medicines is run … working knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20EC), Human Medicines (EU Exit) Regulations 2019 and the International Conference on Harmonisation GCP Guideline (ICH GCP), as applicable to the dispensing of Investigational Medicinal Products for clinical trials or other products e.g. NIMPs, physiological compounds given to study subjects. To facilitate NHS … competency frameworks where appropriate. Clinical Trials To ensure all CTASU staff are in compliance with relevant standards for the operation and management of Clinical Trials, including ICH-GCP and GMP. To ensure all members of the CTASU staff have appropriate ICH-GCP training. To work within the Medicines for Human Use (Clinical Trial) Regulations 2004 and EU More ❯

talk with your recruiter to learn more. Base pay range 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 … years of product management 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 Bachelors degree in a relevant field Previous product management training (Pragmatic Marketing, Design … etc.) Preferred Experience in API-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 compensation package. Cutting-Edge Technology More ❯

and Laboratory Buyer to join our team and source, negotiate, purchase and manage the supply of essential materials and equipment for the facilities department, including both laboratory research and clinical operations. This role involves working closely with the Head of Procurement to ensure that the right equipment is acquired with cost, time efficiency and in compliance with all regulatory … standards. This role offers the opportunity to work in a highly collaborative, fast-paced environment, supporting cutting-edge research whilst playing a critical role in ensuring that laboratory and clinical teams have access to the resources they need for successful project execution. Key Responsibilities: Sourcing & Procurement: Identify, evaluate, and procure high-quality lab and clinical equipment. Obtain quotes … Experience working with laboratory reagents, consumables, equipment, and clinical trial supplies is highly preferred. Knowledge of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and regulatory requirements related to procurement in scientific settings. Desirable Skills, Qualifications & Experience: Experience with procurement software, ERP systems, and inventory management tools is desirable. Educated to MSc or equivalent More ❯

/or safety of medicines e.g., medicines database, safety alerts, formulary changes, protocol and guideline changes etc; and ensure that these are built into the ePMA system and prescribing practice in a timely way Main point of contact to provide highly specialist pharmaceutical knowledge and expertise around all future phases of build, roll-out, ongoing maintenance and future development … of the Trust ePMA system. About us Rated GOOD overall with outstanding care by the CQC. A specialist NHS hospital providing life-changing reconstructive surgery, burns care and rehabilitation services across the South of England and beyond. We specialise in conditions of the eyes (corneoplastics), hands, head and neck cancer and skin cancer, reconstructive breast surgery, maxillofacial surgery and … experience Desirable management qualification Experience Essential extensive delivery of pharmaceutical care to patients managed a clinical pharmacy service multidisciplinary working staff management Service improvement/change involvement Desirable GCP training Knowledge Essential Broad clinical knowledge of drugs and application Advanced clinical pharmacy knowledge in area Knowledge of law and relevant medicines guidance Desirable Demonstrate or working towards More ❯

of delivering excellent patient care that really does re-build our patients’ lives. We also offer attractive benefits such as tailored personal development to support career aspirations, including accredited clinical and management development programmes flexible working arrangements for a work-life balance that suits you and your needs a dedicated reward programme, offering a range of national and local …/or safety of medicines e.g., medicines database, safety alerts, formulary changes, protocol and guideline changes etc; and ensure that these are built into the ePMA system and prescribing practice in a timely way Main point of contact to provide highly specialist pharmaceutical knowledge and expertise around all future phases of build, roll-out, ongoing maintenance and future development … able to demonstrate knowledge through experience Experience extensive delivery of pharmaceutical care to patients managed a clinical pharmacy service multidisciplinary working staff management Service improvement/change involvement GCP training Knowledge Broad clinical knowledge of drugs and application Advanced clinical pharmacy knowledge in area Knowledge of law and relevant medicines guidance Demonstrate or working towards RPS domains More ❯

This job description is not an exhaustive list of areas of responsibility as the requirements of the role are expected to change over time. Personal attributes Honesty and trustworthiness. Good character. Clear DBS. Clarity of thought. Disciplined and professional approach to work. Non-discriminatory and non-judgemental practice. What are the benefits?* Enhanced holiday entitlement & Birthday off after … day ago Hammersmith, England, United Kingdom 2 weeks ago Woking, England, United Kingdom 1 week ago Surrey, England, United Kingdom 1 week ago Clinical Development Quality Manager (GCP) Egham, England, United Kingdom 5 days ago Bracknell, England, United Kingdom 2 weeks ago Customer Services Performance Coach - Fixed Term Contract - 12 months Aldermaston, England, United Kingdom 1 week ago We More ❯