11 Clinical Safety jobs in the United Kingdom
Clinical Safety Officer
Posted today
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Job Role Overview
Clinical Safety Officer - This opening is to join one of the foremost strategy, risk and compliance providers in the UK. We are looking for an experienced Clinical Safety Officer (CSO) to support our growing international client base.
About The AbedGraham Group
Established over a decade ago, The AbedGraham Group has grown in to one of the most trusted consultancies for technology companies and government agencies. We provide a range of strategic, marketing, project management and compliance services for health IT, security, medical device and network infrastructure vendors. Within our compliance service set, we provide DCB0129, Digital Technology Assessment Criteria (DTAC), Data Security and Protection toolkit (DSPT) and cybersecurity services for dozens of the industry’s leading companies.
About the Job
The job role is to join the compliance team at The AbedGraham Group in the capacity of Clinical Safety Officer. Within the NHS, all suppliers of digital technologies that impact patient care are obliged to comply with the mandatory DCB0129 standard and complete DTAC submissions for review by purchasing organisations or regulators. The AbedGraham Group assists dozens of companies with these processes and frequently acts as the Clinical Safety Officer on their behalf. You will be working under the COO to help maintain existing clients’ compliance and ensuring new clients’ requirements are met. Our compliance work extends across a huge range of specialties from primary to secondary to community and mental health care and across dozens of healthcare IT verticals including EHR, document management, radiology, psychiatry, remote monitoring, online and video consultations, community testing, speech recognition and digital dictation, genomics and surgery.
Essential Requirements
- A registered clinician with a UK professional body with at least 2 years’ experience
- An approved Clinical Safety Officer (that is either evidence of NHS Digital’s risk course attendance or a similar accreditation)
- At least 2 years’ experience in either creating or reviewing the standard documents within DCB0129 (clinical safety case report, hazard log, clinical risk management plan/system)
- Knowledge of clinical informatics and its application in multiple healthcare environments
- Knowledge of ongoing compliance requirements (software testing, release reviews, incident management)
- Exceptional communication and documentation skills
- Exceptional productivity and efficiency
Desirable Requirements
- Experience with companies who have Artificial Intelligence (AI) as part of their product set
- Knowledge or experience of medical device regulations including ISO13485 and ISO14971
- Knowledge or experience of deploying healthcare technologies in line with DCB0160 best principles
- Knowledge of wider DTAC competencies (security, data protection, interoperability)
- Experience in or working with NHS Digital or regional/national procurements/rollouts
- Experience with medical device regulation
The Offer
- Fully remote working
- Competitive Salary
- Up to 10% bonus annually
- Private healthcare cover
- Company pension
- All professional training/accreditation requirements and costs covered
- All IT requirements and costs covered
Finally the opportunity for job growth is important to us. The right candidate can expect the responsibility of managing our clients’ work themselves as well as overseeing the work of others in due course. A more strategic role, reporting to the executive board, will also be considered after 12 months. Please send all submissions and CVs to , we look forward to speaking with you and for you to join us on this exciting journey!
Clinical Safety Officer
Posted today
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Manager, Global Submission Management, Clinical Trials

Posted today
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Job Description
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Purpose**
The Submission Manager, Clinical Trials manages and coordinates the timely, compliant, and accurate delivery of the core submission documents and dossiers to Bristol Myers Squibb (BMS) HA/EC Applicants and CRO. The Submission Manager also participates in the preparation of the CTIS for CT under the EU Regulation
**Key Responsibilities**
+ Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs.
+ Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications.
+ Manage the CT Amendment log considering the EU Regulation and determine windows of opportunity for submissions, escalate within BMS
+ Provide support to the Submission Senior Manager/collaborate with the Submission Specialist in CTA preparation activities for initial filings and start up activities, protocol amendments, end of trials and CSR distributions.
+ Ensure consistency of the Clinical Trial application across projects, studies and countries.
+ Lead Program/Study level CTA Tracking Meetings, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations.
+ Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations.
+ Comply with the use and maintenance of the available planning & tracking tools (e.g. Veeva - HA submission and approval Tracking system) to generate reports and track the CTA content and associated dates.
+ Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution
+ Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements.
+ Support initiatives for innovation and simplification in the processes to improve the support to the study teams and GSM-CT.
+ Coordinate updates within a Program.
+ Support continuous improvement and compliance initiatives
+ Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates
+ Contributes to other requirements as appropriate to allow proper functioning of the GSM-CT.
+ Support implementation of the EU CT REG Portal from Feb 2022.
+ Provide training/mentoring to the GSM-CT newcomers
**Required Qualifications & Experience**
+ BA/BS degree in a science or technology field, preferred
+ Extensive relevant regulatory submissions experience
**Key Competencies**
+ Expert knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
+ Assists in the development of short- and long-term goals for own workgroup in alignment with those of GSM and the R&D umbrella.
+ Resolves problems/difficulties with the assistance of senior team members.
+ Supports other functions as appropriate.
+ Independently facilitate compound/study team meetings.
+ Works Independently and collaborates with other functional areas.
#LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is Disability Confident - Employer
A UK Government scheme
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :47:04.767 UTC
**Location:** Uxbridge-GB
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Senior Clinical Trials Lead (Pharmaceutical - Remote)
Posted 1 day ago
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Job Description
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.
Director/Senior Director, Decentralized Clinical Trials (DCT), Business Development & Strategy, E...
Posted 1 day ago
Job Viewed
Job Description
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
Director/Senior Director, Decentralized Clinical Trials (DCT), Business Development & Strategy, E...
Posted 1 day ago
Job Viewed
Job Description
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
Associate Director Drug Safety Scientist
Posted today
Job Viewed
Job Description
CPL Life Sciences are in collaboration with a world-renowned global pharmaceutical company who are seeking two new professionals at varying experience levels to join their Safety Science and Pharmacovigilance team. This role provides scientific safety oversight across the full lifecycle of investigational and marketed products.
As a Safety Scientist, you key responsibilities will include:
- Support safety activities in early and late-phase clinical development
- Conduct signal detection, evaluation, and contribute to risk-benefit assessments
- Manage individual case safety reports (ICSRs) and prepare aggregate reports (e.g., DSURs, PBRERs)
- Participate in the preparation and review of regulatory submissions (INDs, NDAs, MAAs, etc.)
- Contribute to the development and maintenance of safety labeling and core safety documents
- Collaborate with internal teams and external partners to ensure high-quality safety deliverables
- Provide safety input to study teams and participate in cross-functional meetings
- Help prepare materials for safety committees (e.g., iDMCs, IMCs) and regulatory authorities
Hybrid: North London 2 days per week on site, 3 days remote
Applicants should have direct experience working with signal detection, aggregate reports and risk management plans in particular for both clinical and post-marketing activities.
Strong analytical, communication, and collaboration skills are essential for success in this role.
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Associate Director Drug Safety Scientist
Posted today
Job Viewed
Job Description
CPL Life Sciences are in collaboration with a world-renowned global pharmaceutical company who are seeking two new professionals at varying experience levels to join their Safety Science and Pharmacovigilance team. This role provides scientific safety oversight across the full lifecycle of investigational and marketed products.
As a Safety Scientist, you key responsibilities will include:
- Support safety activities in early and late-phase clinical development
- Conduct signal detection, evaluation, and contribute to risk-benefit assessments
- Manage individual case safety reports (ICSRs) and prepare aggregate reports (e.g., DSURs, PBRERs)
- Participate in the preparation and review of regulatory submissions (INDs, NDAs, MAAs, etc.)
- Contribute to the development and maintenance of safety labeling and core safety documents
- Collaborate with internal teams and external partners to ensure high-quality safety deliverables
- Provide safety input to study teams and participate in cross-functional meetings
- Help prepare materials for safety committees (e.g., iDMCs, IMCs) and regulatory authorities
Hybrid: North London 2 days per week on site, 3 days remote
Applicants should have direct experience working with signal detection, aggregate reports and risk management plans in particular for both clinical and post-marketing activities.
Strong analytical, communication, and collaboration skills are essential for success in this role.
Associate Director Drug Safety Scientist
Posted today
Job Viewed
Job Description
Associate Director Drug Safety Scientist
Posted today
Job Viewed