13 Clinical Safety jobs in the United Kingdom

Our client, a leading organisation in **Bristol, South West England, UK**, dedicated to advancing scientific research and development, is seeking a highly skilled and experienced Principal Data Scientist to lead critical projects in clinical trials analysis. This role offers a unique opportunity to leverage advanced statistical methodologies and machine learning techniques to drive insights from complex clinical trial data. You will be responsible for designing data analysis strategies, developing predictive models, and extracting meaningful conclusions that inform critical decision-making in drug development and therapeutic innovation. Collaboration is essential; you will work closely with clinical researchers, statisticians, bioinformaticians, and regulatory experts to ensure the integrity and impact of your analyses. We are looking for a strategic thinker with a deep understanding of statistical modelling, experimental design, and data visualisation. The ideal candidate will possess a strong track record of applying data science to solve challenging problems in a scientific research environment, particularly within the pharmaceutical or biotechnology sectors. Experience with large-scale datasets, complex longitudinal data, and regulatory requirements for clinical trials data is highly desirable. This role demands a passion for scientific discovery, a rigorous approach to data analysis, and the ability to communicate complex findings effectively to diverse audiences. Join us in **Bristol, South West England, UK**, and contribute to the advancement of cutting-edge scientific research.

Key Responsibilities:

• Lead the design and execution of advanced data analysis for clinical trials.
• Develop and implement sophisticated statistical models and machine learning algorithms.
• Extract actionable insights from large, complex datasets related to patient outcomes and treatment efficacy.
• Collaborate with cross-functional teams to define research questions and analytical approaches.
• Mentor junior data scientists and contribute to the development of best practices.
• Present complex analytical findings clearly and concisely to scientific and non-scientific stakeholders.
• Ensure data integrity, quality, and compliance with relevant regulations.
• Stay abreast of the latest advancements in data science, statistical methodologies, and clinical research.
• Contribute to the development of data-driven strategies for R&D initiatives.
• Develop and maintain robust documentation for analytical processes and findings.

Required Qualifications:

• Ph.D. or Master's degree in Statistics, Data Science, Bioinformatics, Computer Science, or a related quantitative field.
• Extensive experience (8+ years) as a Data Scientist, with a significant focus on clinical trial data analysis.
• Expertise in statistical modelling, machine learning techniques, and experimental design.
• Proficiency in programming languages such as R, Python, or SAS.
• Experience with data visualization tools (e.g., Tableau, Power BI).
• Deep understanding of clinical trial phases, methodologies, and regulatory requirements (e.g., FDA, EMA).
• Proven ability to manage complex data projects and lead analytical teams.
• Excellent communication and interpersonal skills.
• Strong problem-solving and critical thinking abilities.

Our client, a prominent pharmaceutical company dedicated to advancing healthcare, is seeking an accomplished Senior Clinical Trials Lead to oversee and manage critical clinical research projects. This role is fully remote, offering the flexibility to work from home anywhere within the UK. You will be responsible for the strategic planning, execution, and successful completion of clinical trials, ensuring adherence to all regulatory requirements, ethical standards, and company protocols. The ideal candidate will possess extensive experience in clinical trial management, with a deep understanding of Good Clinical Practice (GCP), regulatory submissions, and clinical operations. You will have a proven ability to lead cross-functional teams, manage budgets, and mitigate risks associated with clinical trials. Responsibilities include developing clinical trial protocols, selecting and managing clinical sites and investigators, overseeing data collection and monitoring, ensuring timely reporting of trial progress and safety information, and collaborating closely with internal departments (e.g., R&D, regulatory affairs, biostatistics) and external partners. Strong leadership, exceptional organizational skills, and outstanding communication and negotiation abilities are essential. You will play a key role in ensuring the efficient and ethical conduct of studies that contribute to the development of life-changing therapies. This remote position requires a high degree of autonomy, proactivity, and the ability to manage complex projects effectively.

Key Responsibilities:

• Lead the planning, execution, and completion of clinical trials in accordance with established protocols and regulatory guidelines.
• Develop and refine clinical trial protocols and associated documents.
• Oversee the selection, initiation, and monitoring of clinical trial sites and investigators.
• Manage clinical trial budgets, timelines, and resources effectively.
• Ensure compliance with GCP, FDA, EMA, and other relevant regulatory requirements.
• Monitor trial progress, identify potential risks and issues, and implement mitigation strategies.
• Liaise with internal departments, including R&D, regulatory affairs, and medical affairs.
• Oversee data management and ensure the integrity and accuracy of clinical trial data.
• Prepare and present comprehensive clinical trial reports to stakeholders.
• Contribute to the strategic development of the company's clinical development pipeline.

Qualifications:

• Bachelor's degree in a life science, nursing, or related field; advanced degree (MSc, PhD) preferred.
• Minimum of 7-10 years of progressive experience in clinical trial management within the pharmaceutical industry.
• Demonstrated experience in managing Phase I-IV clinical trials.
• In-depth knowledge of GCP, ICH guidelines, and global regulatory requirements.
• Proven leadership and team management skills.
• Excellent project management, organizational, and problem-solving abilities.
• Strong communication, negotiation, and interpersonal skills.
• Experience working effectively in a remote clinical operations environment.

This is a significant opportunity for a seasoned clinical operations professional to drive impactful research and contribute to the development of novel medicines.

**Join us on our exciting journey!**
IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.
**Director/Senior Director, Decentralized Clinical Trials (DCT), Business Development & Strategy, EMEA.**
**1 year contract.**
IQVIA's Decentralized Clinical Trials (DCT) enables remote and hybrid clinical studies by connecting patients through digital tools, wearable devices, and virtual visits. It improves accessibility, speeds up recruitment, and ensures compliance across diverse global regulations.
**Responsibilities**
**Client engagement and understanding of client business.**
+ Captures market share by aligning offerings with client needs and regional trends.
+ Maintains and further establishes strong professional relationships across the client organization; with a particular focus on Decentralized Clinical Trials, proactively but appropriately engages with client teams.
+ Responsible for developing and maintaining deep client knowledge; understanding of their business priorities, organizational culture, product portfolio and pipeline, spend/budget priorities.
+ Manages a systematic client-feedback approach, soliciting information from client teams about experience of working with IQVIA.
**Operations management : Leads on the operational management and oversight of IQVIA's DCT activities for local and international markets**
+ Manage assigned strategic and key account relationships individually or in coordination with Global and Regional Sales Teams
+ Identify and respond to customer needs to define potential opportunities for DCT and propose appropriate tailored solutions in line with client needs.
+ Collaborates with IQVIA's Internal RFX, Pricing & Contracts team to support the sales cycle from RFX to sales.
+ Coordinating across clinical operations, technology, and commercial teams to ensure cohesive delivery of DCT solutions.
**Shaping client's perception of IQVIA**
+ Ensures regulatory and operational alignment by tailoring approaches to accommodate Europe's diverse and complex regulatory landscape
+ Identifies opportunities to engage with Client teams to bring relevant marketing and Thought Leadership materials.
+ Manages the annual Strategic Management Review conference.
+ Identifies, or creates opportunities to introduce relevant IQVIANs or teams who are working in areas of high interest for the client, as part of 'peer to peer' engagement (i.e., beyond IQVIA capability presentations, or specific pitches / RFPs)
**Bringing innovation to Client**
+ The Director will champion innovation, integrating emerging technologies and methodologies to differentiate IQVIA services
+ Building on their knowledge of client priorities and in close partnership with the Clinical, Technology Business Partners, and Global Account Director identifies strategic discussions and major opportunities for IQVIA.
+ Actively engages in the Sales and Account Management community, bringing in relevant ideas and success stories from other major accounts.
**Requirements**
+ Extensive knowledge of Decentralized Clinical Trials
+ 10+ years of experience of working in a Sales, Sales engineer, Business development or similar position within the pharmaceutical, CRO, Tech, health, life science or other related regulated industry
+ Proven track record of managing mid-level and high-level contacts
+ Strong organizational, planning, project management skills
+ A developing record of customer contacts at the outsourcing, procurement and mid - management level
+ Excellent Business/Industry awareness and a thorough understanding of industry trends and impact on the business
+ Excellent analytical skills in assessing and interpreting customer business data
+ Ability to maintain demanding timelines
+ Ability to influence others internally and externally
+ Adaptability and flexibility to changing priorities
+ Demonstrated ability to work creatively in a fast-paced environment
+ Exceptional attention to detail and ability to work simultaneously on multiple priorities
+ Ability to work independently and as a team player
+ Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel
+ Excellent oral and written communication skills
+ Ability to establish and maintain effective working relationships with co-workers, managers, and clients
**Why Join?**
Those who join us become part of a recognized global leader still willing to challenge the status quo to improve patient care. In Technology, you will have access to the most cutting-edge technology, the largest data sets, the best analytics tools and, in our opinion, some of the finest minds in the Healthcare industry.
You can drive your career at IQVIA and choose the path that best defines your development and success. With exposure across diverse geographies, capabilities, and vast therapeutic and information and technology areas, you can seek opportunities to change and grow without boundaries.
We know that meaningful results require not only the right approach but also **the right people** . Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
It's an exciting time to join and reimagine what's possible in healthcare.
**Moving healthcare forward. Together.**
_IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential._
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

**Join us on our exciting journey!**
IQVIA is The Human Data Science Company, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.
**Director/Senior Director, Decentralized Clinical Trials (DCT), Business Development & Strategy, EMEA.**
**1 year contract.**
IQVIA's Decentralized Clinical Trials (DCT) enables remote and hybrid clinical studies by connecting patients through digital tools, wearable devices, and virtual visits. It improves accessibility, speeds up recruitment, and ensures compliance across diverse global regulations.
**Responsibilities**
**Client engagement and understanding of client business.**
+ Captures market share by aligning offerings with client needs and regional trends.
+ Maintains and further establishes strong professional relationships across the client organization; with a particular focus on Decentralized Clinical Trials, proactively but appropriately engages with client teams.
+ Responsible for developing and maintaining deep client knowledge; understanding of their business priorities, organizational culture, product portfolio and pipeline, spend/budget priorities.
+ Manages a systematic client-feedback approach, soliciting information from client teams about experience of working with IQVIA.
**Operations management : Leads on the operational management and oversight of IQVIA's DCT activities for local and international markets**
+ Manage assigned strategic and key account relationships individually or in coordination with Global and Regional Sales Teams
+ Identify and respond to customer needs to define potential opportunities for DCT and propose appropriate tailored solutions in line with client needs.
+ Collaborates with IQVIA's Internal RFX, Pricing & Contracts team to support the sales cycle from RFX to sales.
+ Coordinating across clinical operations, technology, and commercial teams to ensure cohesive delivery of DCT solutions.
**Shaping client's perception of IQVIA**
+ Ensures regulatory and operational alignment by tailoring approaches to accommodate Europe's diverse and complex regulatory landscape
+ Identifies opportunities to engage with Client teams to bring relevant marketing and Thought Leadership materials.
+ Manages the annual Strategic Management Review conference.
+ Identifies, or creates opportunities to introduce relevant IQVIANs or teams who are working in areas of high interest for the client, as part of 'peer to peer' engagement (i.e., beyond IQVIA capability presentations, or specific pitches / RFPs)
**Bringing innovation to Client**
+ The Director will champion innovation, integrating emerging technologies and methodologies to differentiate IQVIA services
+ Building on their knowledge of client priorities and in close partnership with the Clinical, Technology Business Partners, and Global Account Director identifies strategic discussions and major opportunities for IQVIA.
+ Actively engages in the Sales and Account Management community, bringing in relevant ideas and success stories from other major accounts.
**Requirements**
+ Extensive knowledge of Decentralized Clinical Trials
+ 10+ years of experience of working in a Sales, Sales engineer, Business development or similar position within the pharmaceutical, CRO, Tech, health, life science or other related regulated industry
+ Proven track record of managing mid-level and high-level contacts
+ Strong organizational, planning, project management skills
+ A developing record of customer contacts at the outsourcing, procurement and mid - management level
+ Excellent Business/Industry awareness and a thorough understanding of industry trends and impact on the business
+ Excellent analytical skills in assessing and interpreting customer business data
+ Ability to maintain demanding timelines
+ Ability to influence others internally and externally
+ Adaptability and flexibility to changing priorities
+ Demonstrated ability to work creatively in a fast-paced environment
+ Exceptional attention to detail and ability to work simultaneously on multiple priorities
+ Ability to work independently and as a team player
+ Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel
+ Excellent oral and written communication skills
+ Ability to establish and maintain effective working relationships with co-workers, managers, and clients
**Why Join?**
Those who join us become part of a recognized global leader still willing to challenge the status quo to improve patient care. In Technology, you will have access to the most cutting-edge technology, the largest data sets, the best analytics tools and, in our opinion, some of the finest minds in the Healthcare industry.
You can drive your career at IQVIA and choose the path that best defines your development and success. With exposure across diverse geographies, capabilities, and vast therapeutic and information and technology areas, you can seek opportunities to change and grow without boundaries.
We know that meaningful results require not only the right approach but also **the right people** . Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.
It's an exciting time to join and reimagine what's possible in healthcare.
**Moving healthcare forward. Together.**
_IQVIA is a strong advocate of diversity and inclusion in the workplace. We believe that a work environment that embraces diversity will give us a competitive advantage in the global marketplace and enhance our success. We believe that an inclusive and respectful workplace culture fosters a sense of belonging among our employees, builds a stronger team, and allows individual employees the opportunity to maximize their personal potential._
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

Our client, a globally recognized pharmaceutical leader, is seeking a highly experienced Senior Drug Safety Scientist to join their Pharmacovigilance team. This pivotal role is entirely remote, offering the flexibility to work from home across the UK while contributing to the safety monitoring of critical medicines. You will be responsible for ensuring the robust safety surveillance of pharmaceutical products, from clinical development through to post-marketing, and safeguarding patient well-being.

Responsibilities:

• Perform comprehensive case processing and medical assessment of adverse event reports, ensuring compliance with regulatory requirements and company procedures.
• Contribute to the preparation and maintenance of periodic safety update reports (PSURs), development safety update reports (DSURs), and risk management plans (RMPs).
• Conduct signal detection and evaluation activities, identifying potential safety concerns and recommending appropriate actions.
• Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, on safety-related matters.
• Interpret safety data and provide expert input into clinical trial protocols, Investigator's Brochures, and informed consent forms.
• Serve as a subject matter expert on drug safety regulations and guidelines in various global markets.
• Contribute to the development and implementation of pharmacovigilance strategies and processes.
• Participate in regulatory authority inspections and internal audits.
• Mentor and provide guidance to junior safety scientists and case processing personnel.
• Stay current with evolving regulatory landscapes and scientific literature related to drug safety.

Qualifications:

• Medical degree (MD, DO, MBBS) or equivalent healthcare professional qualification (e.g., PhD in a relevant life science field with significant safety experience).
• Minimum of 6 years of direct experience in drug safety and pharmacovigilance within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA guidelines) and reporting requirements.
• Experience with safety databases (e.g., Argus, ARISg) and case processing.
• Proficiency in signal detection and management methodologies.
• Strong medical assessment and analytical skills, with the ability to critically evaluate safety data.
• Excellent written and verbal communication skills, with the ability to present complex information effectively.
• Proven ability to work independently and manage multiple priorities in a remote setting.
• Strong collaboration and interpersonal skills.
• Experience with risk management planning and execution.

This is an exceptional opportunity for a seasoned professional to make a significant impact on patient safety from a fully remote location. You will be part of a highly respected global team committed to excellence in pharmacovigilance. The role is aligned with the strategic goals for the London, England, UK area, but is entirely remote.

Our client, a leading contract research organisation (CRO) at the forefront of pharmaceutical innovation, is seeking a dedicated and meticulous Clinical Research Associate (CRA) to join their esteemed team in Southampton, Hampshire, UK . This role is pivotal in ensuring the successful execution of clinical trials, particularly in the highly specialised field of oncology. As a CRA, you will be responsible for monitoring clinical trial sites to ensure data integrity, patient safety, and adherence to protocol, Good Clinical Practice (GCP), and regulatory requirements. This hybrid role offers a blend of remote work flexibility and essential on-site visits to clinical investigational sites, demanding excellent organisational skills and the ability to travel. You will be working on cutting-edge therapies and playing a vital part in bringing new treatments to patients. The ideal candidate will possess a strong scientific background, exceptional attention to detail, and a passion for advancing medical science.

Key Responsibilities:

• Perform site initiation, monitoring, and close-out visits in accordance with study protocols and regulatory guidelines.
• Ensure adherence to Good Clinical Practice (GCP), International Conference on Harmonisation (ICH) guidelines, and all applicable regulatory requirements.
• Verify the accuracy, completeness, and consistency of clinical data reported by investigators.
• Review and verify source documents against case report forms (CRFs).
• Manage and resolve data queries and ensure timely resolution of site issues.
• Oversee drug accountability and manage investigational product at study sites.
• Build and maintain strong working relationships with principal investigators, site staff, and other study stakeholders.
• Train site personnel on study procedures, protocol requirements, and regulatory compliance.
• Prepare monitoring visit reports and ensure follow-up actions are completed.
• Contribute to the development of study-related documents, including protocols, CRFs, and informed consent forms.
• Act as a key liaison between the sponsor, investigational sites, and regulatory authorities.
• Ensure patient safety and protocol compliance throughout the trial lifecycle.
• Participate in investigator meetings and provide essential study updates.
• Manage travel arrangements and submit expense reports in a timely manner.

Qualifications:

• Bachelor's degree in a life science, nursing, or a related field.
• Proven experience as a Clinical Research Associate, with specific experience in oncology trials highly desirable.
• In-depth knowledge of ICH-GCP guidelines and regulatory requirements for clinical trials.
• Excellent understanding of medical terminology and clinical trial processes.
• Strong organisational, time management, and problem-solving skills.
• Exceptional attention to detail and accuracy.
• Proficient in the use of clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Excellent written and verbal communication skills.
• Ability to travel frequently to clinical sites (estimated 50-60% travel).
• Self-motivated, proactive, and able to work independently with minimal supervision.
• Commitment to ethical conduct and patient well-being.

A leading pharmaceutical company focused on groundbreaking oncology treatments is seeking a highly organized and experienced Clinical Operations Manager to oversee the execution of critical clinical trials. This role is based at our state-of-the-art facility in Coventry, West Midlands, UK . The ideal candidate will have a deep understanding of clinical trial processes, regulatory requirements, and a passion for advancing cancer care.

As the Clinical Operations Manager, you will be responsible for the day-to-day management of clinical trial sites, ensuring that trials are conducted according to protocol, Good Clinical Practice (GCP), and regulatory standards. You will manage study timelines, budgets, and resources, working closely with internal teams and external vendors to achieve trial milestones. Your leadership will be key to the successful delivery of life-changing therapies.

Key Responsibilities:

• Oversee the planning, execution, and completion of clinical trials from initiation to close-out.
• Manage and monitor clinical trial sites, ensuring adherence to protocols, GCP, and regulatory guidelines.
• Develop and manage clinical trial budgets, tracking expenses and ensuring cost-effectiveness.
• Select, train, and supervise Clinical Research Associates (CRAs) and other site staff.
• Collaborate with cross-functional teams, including data management, biostatistics, regulatory affairs, and medical affairs.
• Develop and implement risk management strategies for clinical trials.
• Ensure timely submission of essential documents and regulatory filings.
• Oversee the management of investigational product supplies and study-specific equipment.
• Build and maintain strong relationships with investigators, site staff, and key opinion leaders.
• Prepare and deliver progress reports to senior management and relevant stakeholders.

Qualifications:

• Bachelor's degree in a life science, nursing, or related field; advanced degree preferred.
• Minimum of 5 years of experience in clinical trial management within the pharmaceutical or biotech industry.
• Proven experience managing oncology clinical trials.
• In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
• Strong project management skills, with the ability to manage multiple complex trials simultaneously.
• Excellent leadership, communication, and interpersonal skills.
• Experience with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel as needed (approximately 20-30%).
• Demonstrated ability to work effectively in a team environment and manage cross-functional collaborations.
• Problem-solving skills and a proactive approach to identifying and mitigating risks.

This is an exceptional opportunity to contribute significantly to the development of innovative cancer therapies. Join our dedicated team in Coventry and play a vital role in bringing hope to patients worldwide. We offer a competitive compensation package, excellent benefits, and a stimulating work environment.

Our client, a globally recognized pharmaceutical organization with a strong pipeline of innovative medicines, is seeking a dedicated Senior Regulatory Affairs Specialist with a focus on Drug Safety. This office-based role in Brighton, East Sussex, UK offers a vital opportunity to ensure product compliance and patient safety. You will be responsible for managing pharmacovigilance activities, submissions, and compliance with global regulatory requirements. The ideal candidate will possess in-depth knowledge of regulatory affairs, drug safety principles, and a meticulous approach to documentation and compliance. Key Responsibilities:

• Manage and oversee regulatory submissions related to drug safety, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and periodic safety update reports (PSURs).
• Ensure compliance with global pharmacovigilance regulations (e.g., GVP Modules, FDA regulations) and company policies.
• Prepare, review, and submit safety-related regulatory documents to health authorities worldwide.
• Liaise with global regulatory agencies to address queries and provide necessary information regarding drug safety.
• Collaborate closely with internal departments, including Clinical Development, Medical Affairs, and Quality Assurance, to ensure integrated safety reporting and compliance.
• Monitor regulatory changes and assess their impact on company products and processes.
• Develop and maintain regulatory submission documentation and databases.
• Contribute to the development and implementation of company SOPs related to regulatory affairs and drug safety.
• Provide expert advice and guidance on regulatory requirements to cross-functional teams.
• Participate in regulatory inspections and audits, ensuring preparedness and compliance.
• Support post-marketing safety surveillance activities and submissions.

Qualifications:

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. A Master's degree or equivalent is highly preferred.
• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry, with a specialization in drug safety/pharmacovigilance.
• Thorough understanding of global regulatory requirements for drug safety and GxP.
• Proven experience in preparing and submitting safety-related regulatory documents.
• Excellent knowledge of pharmacovigilance principles and reporting requirements.
• Strong analytical, problem-solving, and organizational skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
• Proficiency in regulatory information management systems and safety databases.
• Ability to work independently, manage multiple priorities, and meet strict deadlines.
• Attention to detail and a commitment to maintaining the highest standards of compliance.
• Candidates must be based in or willing to relocate to the Brighton, East Sussex, UK area for this office-based position.

This is a critical role ensuring the safety and compliance of pharmaceutical products, based in the beautiful coastal city of Brighton, East Sussex, UK .

Our client, a leading global pharmaceutical company, is seeking a highly experienced Senior Clinical Research Associate (CRA) specializing in Oncology trials. This role offers a hybrid working model, allowing for a blend of remote work and on-site contributions at their **Southampton, Hampshire, UK** facility. You will be instrumental in managing and monitoring clinical trials from initiation to closure, ensuring adherence to Good Clinical Practice (GCP) guidelines, protocol compliance, and data integrity. This position demands a rigorous approach to site management, strong analytical skills, and excellent communication capabilities to foster effective relationships with investigators, site staff, and internal teams.

Key Responsibilities:

• Conduct site feasibility, initiation, monitoring, and close-out visits for Phase I-IV oncology clinical trials.
• Ensure all trial activities at assigned sites are conducted in compliance with GCP, ICH guidelines, protocol, and regulatory requirements.
• Monitor study conduct, data accuracy, source document verification, and regulatory documentation.
• Manage communication and relationships with Principal Investigators and site staff, providing guidance and support.
• Identify potential risks and issues at clinical sites and implement corrective and preventive actions (CAPAs).
• Oversee site performance metrics, including recruitment rates, data quality, and regulatory compliance.
• Prepare and present study-related reports, including monitoring visit reports and summaries.
• Participate in the selection and training of new CRAs and site personnel.
• Contribute to the development and review of clinical trial protocols, informed consent forms, and other study documents.
• Stay current with regulatory updates and industry best practices in clinical research.

Required Qualifications and Experience:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific discipline. A Master's degree is a plus.
• Minimum of 5-8 years of direct experience as a CRA, with a significant focus on oncology clinical trials.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements for clinical research.
• Demonstrated ability to successfully manage multiple clinical sites and complex trials.
• Excellent monitoring skills, including source data verification and query resolution.
• Strong analytical, problem-solving, and decision-making abilities.
• Exceptional written and verbal communication skills, with the ability to build rapport and influence stakeholders.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Ability to travel as required to assigned clinical sites (approximately 50-60%).
• Experience working in a hybrid environment, balancing remote and office-based tasks.

This is an exciting opportunity for a seasoned CRA to contribute to groundbreaking oncology research. If you are passionate about advancing cancer treatment and seeking a hybrid role that offers professional growth and impact, we encourage you to apply for this position based out of **Southampton, Hampshire, UK**.