Parexel

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose: moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®. About the Role We are seeking a Senior Software Engineer to join our team, supporting the clinical research and pharmaceutical industries. As a Senior Software Engineer, you will design, implement, and architect software products and product extensions that support clinical trial information sharing and the pharmaceutical clients we serve. This position plays a key role in delivering the software and data solutions that clinical research depends on, supporting data quality, efficient information sharing, and reliable application support. You'll collaborate with stakeholders across matrix teams, follow agreed development standards and Agile practices, and contribute from design through live deployment. Responsibilities include designing and architecting software and database solutions, mentoring Software Engineers, producing technical artifacts, and supporting release management, with opportunities to deepen your expertise and shape solutions that influence clinical programs. You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through designing clinical trial information sharing solutions, delivering technical consulting to pharmaceutical clients, and mentoring fellow engineers. With diverse teams and continuous learning opportunities, the Senior Software Engineer can explore career paths and expand skills across clinical research. Key Responsibilities Design, implement, and architect software products, translating logical designs into physical designs that account for the target environment, performance, security, and existing systems. Design, implement, and architect product extensions that meet customer-specific requirements. Apply data analysis, data modeling, and quality assurance techniques to establish, modify, and maintain data structures, object and data models, and database designs, advising database designers and development team members. Design, code, test, correct, and document complex programs and scripts from agreed specifications using agreed standards and tools, taking part in peer reviews and leading reviews of colleagues' work. Specify user and system interfaces and produce detailed designs, documented to required standards, methods, and tools, including prototyping where appropriate. Mentor and provide technical guidance for Software Engineers. Adhere to development standards and produce artifacts, including technical specifications, architectural specifications, data models, installation and qualification guides, and release notes. Design and support clinical trials information sharing solutions. Support technical consulting activities for clients in the pharmaceutical industry. Provide application support for existing products. Help with release management using versioning tools such as SVN or GitHub and execute live deployments. You'll thrive in this role if you bring: Strengths in system architecture frameworks and concepts, application software development, and technical awareness of security. Interest in or experience working in clinical research, healthcare, or a regulated environment. Excellent interpersonal, verbal, and written communication skills, with a willingness to work in a matrix environment and a strong appreciation for teamwork. A client-focused approach to work and a commitment to quality assurance. Comfort working with Visual Studio, Agile development methodology, and versioning tools such as SVN or GitHub. Required Qualifications Bachelor's degree in technical discipline (such as mathematics, science, engineering, or computing) or a related study, or equivalent project-related experience. Proven relevant experience in systems integrat

When our values align, there's no limit to what we can achieve. At Parexel , we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel , contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. About the Role We are seeking an experienced Senior Clinical Research Associate based in the UK, ideally in the South West of England (or at least willing to travel there regularly), to join one of our key sponsors. This role is responsible for the successful delivery of clinical studies at assigned investigator sites, serving as the primary point of contact for site management, monitoring, and study execution activities. As an active member of the local study team, you will work closely with clinical operations colleagues and stakeholders to ensure high quality study delivery, patient safety, regulatory compliance, and operational excellence. This is an opportunity to contribute directly to the advancement of innovative therapies while building your expertise within a world class research environment. Key Responsibilities Lead the preparation, initiation, routine monitoring, and close out of assigned clinical trial sites in accordance with protocol requirements, ICH GCP guidelines, sponsor procedures, and local regulations. Serve as the primary contact for investigative sites, building strong partnerships that support successful study execution and patient recruitment goals. Train, support, and advise investigators and site personnel on study requirements, protocol execution, and Risk Based Quality Management principles. Conduct onsite and remote monitoring visits, source data review, source data verification, and case report form review in accordance with study monitoring plans. Proactively identify, manage, and escalate site and study related issues to ensure timely resolution and continued study progress. Perform site quality risk assessments and adapt monitoring activities as appropriate throughout the study lifecycle. Ensure timely and accurate reporting of serious adverse events, query resolution, and quality study data collection. Maintain accurate and up to date study information within CTMS and other required clinical systems. Support the collection, review, upload, and maintenance of essential documents within the eTMF and investigator site files, ensuring inspection readiness. Collaborate with local study teams, quality colleagues, and other stakeholders to support audits, inspections, and successful study delivery. Manage study supplies, study drug accountability activities, and associated documentation as required. Contribute insights regarding site performance, investigator engagement, and local research landscapes to support study success. Candidate Profile You’ll thrive in this role if you bring: Strong capabilities in site management, clinical monitoring, and stakeholder engagement. Experience working within clinical research and regulated environments. The ability to collaborate effectively across cross functional teams and communicate confidently with investigators and site personnel. A patient focused mindset and commitment to quality, compliance, and operational excellence. Comfort working with CTMS, eTMF, remote monitoring tools, and other clinical trial systems. Strong organizational skills with the ability to manage multiple priorities and timelines A proactive approach to problem solving and continuous improvement. Required Qualifications Bachelor’s degree in a life science or related discipline, or equivalent experience aligned with local market requirements. Significant clinical research experience with demonstrated expertise in site monitoring and clinical trial execution. Excellent knowledge of ICH GCP and working knowledge of applicable local regulatory requirements. Good understanding of clinical study management, study drug handling, data management, and clinical trial processes. Experience using CTMS, eTMF, and other clinical research technologies and systems. Strong written and verbal communication, organizational, and problem solving skills. Proficiency in written and spoken English. Ability to travel nationally and internationally as required. Valid driving licence in accordance with local country requirements, where applicable. Preferred Qualifications Experience supporting global clinical studies within a pharmaceutical or biotechnology environment. Familiarity with risk based monitoring approaches, including remote monitoring methodologies. Experience performing as a CRA/Senior CRA within Oncology clinical trials. Experience supporting regulatory inspections and audit readiness activities. Strong cultural awareness and experience c