593 Clinical Trial Manager jobs in the United Kingdom
Clinical Trial Manager
Posted today
Job Viewed
Job Description
Global Study Manager
Duration - 12 months (interim)
Location - Remote
Inside IR35
The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.
Responsibilities:
• Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
• Lead the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
• Manage the set-up of third-party vendors assessing initial statement of work and budget, as well as the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
• Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
• Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
• Support risk management and quality efforts to ensure study compliance.
• Support set-up, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
• Prepare presentation material for meetings, newsletters and websites.
• Support the study team in the implementation of audits and regulatory inspections.
• Contribute to review of new/amended/unique SOPs and guidance documents.
Essential Skills/Requirements:
University degree / Bachelor’s degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
• Minimum of 3-4 years of progressive clinical trial experience
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Excellent knowledge of ICH-GCP principles
• Demonstrated verbal and written communication skills
• Early Phase experience (phase I and IIa)
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements
Clinical Trial Manager
Posted today
Job Viewed
Job Description
About Summit:
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:
- HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
- HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
- HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting .
Overview of Role:
The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.
Role and Responsibilities:
- Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
- Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
- Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
- Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
- Proactive identification and management of study related risks
- Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
- Responsible for reviewing and managing study related plans, processes including
- Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
- Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
- Reviews and approves essential document packages to enable timely site activations
- Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
- Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
- Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
- Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
- Perform periodic QC of the TMF
- Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
- Ensures the study is “inspection ready” always
- Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
- 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
- Prior phase II and III experience required
- A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
- Experience with budget forecasting and management
- Experience with clinical studies in oncology
- Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
- Proven proficiency in overseeing large complex studies being managed in house and by a CRO
- Demonstrated ability to lead teams and work in a fast-paced team environment
- Experienced and enjoys building relationships with KOLs and site personnel
- Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
- Demonstrated ability to build and deliver on patient enrollment strategies
- Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
- Demonstrated ability to comprehend complex scientific concepts and data
- Proficient in reviewing and assessing clinical data
- Possesses excellent planning, time management & coordination skills
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
- Experience in working in a small organization
- Excellent written and oral communication skills
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Clinical Trial Manager
Posted today
Job Viewed
Job Description
We are seeking an experienced Clinical Trial Manager to join a London-based biotech and lead the planning, execution, and delivery of clinical trials. The successful candidate will excel in fast-paced, dynamic biotech settings and be committed to driving trials that meet the highest standards of quality, compliance, and operational excellence.
Responsibilities:
- Lead the design, start-up, and execution of clinical trials, ensuring projects are completed on schedule, within scope, and aligned with budgetary expectations.
- Serve as the primary sponsor contact for CROs, investigators, and providers.
- Oversee CRO performance, including reviewing monitoring outputs and KPIs.
- Work closely with Regulatory Affairs on ethics/regulatory submissions, ensuring alignment with ICH-GCP guidelines and current UK/EU regulations.
- Maintain trial inspection readiness, overseeing safety reporting, audit response, and vendor governance.
- Develop and review protocols, informed consent forms, and study reports.
- Drive risk management, issue resolution, and collaboration across cross-functional teams.
- Play an active role in refining operational processes and SOPs within the Clinical Operations function.
Requirements:
- Bachelor’s degree (or equivalent) in a life science or health-related discipline.
- Minimum of 8 years in clinical trial management across pharma, biotech, or CROs.
- Site monitoring experience or proven ability to critically evaluate CRO monitoring performance.
- In-depth understanding of ICH-GCP and global regulatory requirements, with strong understanding of upcoming UK/EU regulatory changes (e.g., UK CTR 2026).
- Demonstrated success in managing CROs and vendors, including financial oversight.
- Skilled at balancing multiple priorities and tight timelines.
- Proficient in navigating lean, fast-paced environments; direct experience in biotech settings is valued.
- Strong interpersonal and communication skills, with proven ability to manage internal stakeholders with accountability and transparency.
- Able to work on-site in central London in a hybrid capacity.
Clinical Trial Manager
Posted today
Job Viewed
Job Description
We are seeking an experienced Clinical Trial Manager to join a London-based biotech and lead the planning, execution, and delivery of clinical trials. The successful candidate will excel in fast-paced, dynamic biotech settings and be committed to driving trials that meet the highest standards of quality, compliance, and operational excellence.
Responsibilities:
- Lead the design, start-up, and execution of clinical trials, ensuring projects are completed on schedule, within scope, and aligned with budgetary expectations.
- Serve as the primary sponsor contact for CROs, investigators, and providers.
- Oversee CRO performance, including reviewing monitoring outputs and KPIs.
- Work closely with Regulatory Affairs on ethics/regulatory submissions, ensuring alignment with ICH-GCP guidelines and current UK/EU regulations.
- Maintain trial inspection readiness, overseeing safety reporting, audit response, and vendor governance.
- Develop and review protocols, informed consent forms, and study reports.
- Drive risk management, issue resolution, and collaboration across cross-functional teams.
- Play an active role in refining operational processes and SOPs within the Clinical Operations function.
Requirements:
- Bachelor’s degree (or equivalent) in a life science or health-related discipline.
- Minimum of 8 years in clinical trial management across pharma, biotech, or CROs.
- Site monitoring experience or proven ability to critically evaluate CRO monitoring performance.
- In-depth understanding of ICH-GCP and global regulatory requirements, with strong understanding of upcoming UK/EU regulatory changes (e.g., UK CTR 2026).
- Demonstrated success in managing CROs and vendors, including financial oversight.
- Skilled at balancing multiple priorities and tight timelines.
- Proficient in navigating lean, fast-paced environments; direct experience in biotech settings is valued.
- Strong interpersonal and communication skills, with proven ability to manage internal stakeholders with accountability and transparency.
- Able to work on-site in central London in a hybrid capacity.
Clinical Trial Manager
Posted today
Job Viewed
Job Description
About Summit:
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:
- HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
- HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
- HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting .
Overview of Role:
The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.
Role and Responsibilities:
- Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
- Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
- Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
- Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
- Proactive identification and management of study related risks
- Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
- Responsible for reviewing and managing study related plans, processes including
- Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
- Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
- Reviews and approves essential document packages to enable timely site activations
- Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
- Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
- Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
- Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
- Perform periodic QC of the TMF
- Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
- Ensures the study is “inspection ready” always
- Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
- 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
- Prior phase II and III experience required
- A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
- Experience with budget forecasting and management
- Experience with clinical studies in oncology
- Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
- Proven proficiency in overseeing large complex studies being managed in house and by a CRO
- Demonstrated ability to lead teams and work in a fast-paced team environment
- Experienced and enjoys building relationships with KOLs and site personnel
- Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
- Demonstrated ability to build and deliver on patient enrollment strategies
- Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
- Demonstrated ability to comprehend complex scientific concepts and data
- Proficient in reviewing and assessing clinical data
- Possesses excellent planning, time management & coordination skills
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
- Experience in working in a small organization
- Excellent written and oral communication skills
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Clinical trial manager
Posted 15 days ago
Job Viewed
Job Description
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the successful delivery of clinical trial outcomes.
**What you will be doing**
+ Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
+ Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
+ Build and manage strong relationships with trial investigators and stakeholders.
+ Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
+ Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
Your Profile
+ University degree in medicine, science, or equivalent combination of education & experience
+ Demonstrated ability to drive the clinical deliverables of a study
+ Subject matter expertise in the designated therapeutic area
+ Prior monitoring experience is preferred
+ Ability to travel up to 20%
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
Clinical Trial Manager
Posted today
Job Viewed
Job Description
About Summit:
Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.
Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials:
- HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).
- HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
- HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.
Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting .
Overview of Role:
The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial.
Role and Responsibilities:
- Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met
- Initiates and builds solid professional relationships with key opinion leaders and clinical site staff
- Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time
- Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data
- Proactive identification and management of study related risks
- Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements
- Responsible for reviewing and managing study related plans, processes including
- Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring
- Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met
- Reviews and approves essential document packages to enable timely site activations
- Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report
- Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates
- Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
- Responsible for oversight on the maintenance of the TMF and completeness at the end of the study
- Perform periodic QC of the TMF
- Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
- Ensures the study is “inspection ready” always
- Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred
- 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization
- Prior phase II and III experience required
- A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process
- Experience with budget forecasting and management
- Experience with clinical studies in oncology
- Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%)
- Proven proficiency in overseeing large complex studies being managed in house and by a CRO
- Demonstrated ability to lead teams and work in a fast-paced team environment
- Experienced and enjoys building relationships with KOLs and site personnel
- Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues
- Demonstrated ability to build and deliver on patient enrollment strategies
- Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives
- Demonstrated ability to comprehend complex scientific concepts and data
- Proficient in reviewing and assessing clinical data
- Possesses excellent planning, time management & coordination skills
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs
- Experience in working in a small organization
- Excellent written and oral communication skills
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
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Clinical Trial Manager
Posted today
Job Viewed
Job Description
We are seeking an experienced Clinical Trial Manager to join a London-based biotech and lead the planning, execution, and delivery of clinical trials. The successful candidate will excel in fast-paced, dynamic biotech settings and be committed to driving trials that meet the highest standards of quality, compliance, and operational excellence.
Responsibilities:
- Lead the design, start-up, and execution of clinical trials, ensuring projects are completed on schedule, within scope, and aligned with budgetary expectations.
- Serve as the primary sponsor contact for CROs, investigators, and providers.
- Oversee CRO performance, including reviewing monitoring outputs and KPIs.
- Work closely with Regulatory Affairs on ethics/regulatory submissions, ensuring alignment with ICH-GCP guidelines and current UK/EU regulations.
- Maintain trial inspection readiness, overseeing safety reporting, audit response, and vendor governance.
- Develop and review protocols, informed consent forms, and study reports.
- Drive risk management, issue resolution, and collaboration across cross-functional teams.
- Play an active role in refining operational processes and SOPs within the Clinical Operations function.
Requirements:
- Bachelor’s degree (or equivalent) in a life science or health-related discipline.
- Minimum of 8 years in clinical trial management across pharma, biotech, or CROs.
- Site monitoring experience or proven ability to critically evaluate CRO monitoring performance.
- In-depth understanding of ICH-GCP and global regulatory requirements, with strong understanding of upcoming UK/EU regulatory changes (e.g., UK CTR 2026).
- Demonstrated success in managing CROs and vendors, including financial oversight.
- Skilled at balancing multiple priorities and tight timelines.
- Proficient in navigating lean, fast-paced environments; direct experience in biotech settings is valued.
- Strong interpersonal and communication skills, with proven ability to manage internal stakeholders with accountability and transparency.
- Able to work on-site in central London in a hybrid capacity.
Clinical Trial Manager
Posted today
Job Viewed
Job Description
We are seeking an experienced Clinical Trial Manager to join a London-based biotech and lead the planning, execution, and delivery of clinical trials. The successful candidate will excel in fast-paced, dynamic biotech settings and be committed to driving trials that meet the highest standards of quality, compliance, and operational excellence.
Responsibilities:
- Lead the design, start-up, and execution of clinical trials, ensuring projects are completed on schedule, within scope, and aligned with budgetary expectations.
- Serve as the primary sponsor contact for CROs, investigators, and providers.
- Oversee CRO performance, including reviewing monitoring outputs and KPIs.
- Work closely with Regulatory Affairs on ethics/regulatory submissions, ensuring alignment with ICH-GCP guidelines and current UK/EU regulations.
- Maintain trial inspection readiness, overseeing safety reporting, audit response, and vendor governance.
- Develop and review protocols, informed consent forms, and study reports.
- Drive risk management, issue resolution, and collaboration across cross-functional teams.
- Play an active role in refining operational processes and SOPs within the Clinical Operations function.
Requirements:
- Bachelor’s degree (or equivalent) in a life science or health-related discipline.
- Minimum of 8 years in clinical trial management across pharma, biotech, or CROs.
- Site monitoring experience or proven ability to critically evaluate CRO monitoring performance.
- In-depth understanding of ICH-GCP and global regulatory requirements, with strong understanding of upcoming UK/EU regulatory changes (e.g., UK CTR 2026).
- Demonstrated success in managing CROs and vendors, including financial oversight.
- Skilled at balancing multiple priorities and tight timelines.
- Proficient in navigating lean, fast-paced environments; direct experience in biotech settings is valued.
- Strong interpersonal and communication skills, with proven ability to manage internal stakeholders with accountability and transparency.
- Able to work on-site in central London in a hybrid capacity.
Clinical Trial Manager
Posted 24 days ago
Job Viewed
Job Description
You’ll serve as a strategic point of contact for internal teams, CROs, clinical sites, and vendors — delivering high-quality clinical trials on time and within budget. This is an excellent opportunity for a professional looking to advance their leadership career in clinical research management .
Job Responsibilities
Oversee clinical trial planning and implementation from protocol development through final study reportLead cross-functional teams (CRA, Data Management, Regulatory, Biostatistics) and manage CRO oversightDevelop and manage study budgets, timelines, and site selectionMonitor trial metrics, risk mitigation plans, and vendor performanceEnsure quality and regulatory compliance with ICH-GCP , EMA , MHRA , and FDA standardsServe as main point of contact for clinical sites, investigators, and stakeholdersCoordinate and lead internal/external team meetings and status reports.Manage documentation and trial master files (TMF) to inspection-ready standardsRequirementsRequired Skills
Extensive understanding of clinical trial regulations, GCP , ICH , and MHRA requirementsProven experience managing global or multi-site clinical studiesExcellent leadership, team coordination, and stakeholder management skillsStrong command of trial budget and vendor oversightProficient with EDC systems, CTMS, and MS Office toolsDesired Skills
Life sciences or health sciences degree (BSc, MSc, or equivalent)ACRP, SOCRA, or equivalent clinical research certificationExperience with oncology, rare disease, or CNS trialsFamiliarity with EU CTR and decentralised trial models BenefitsJob Benefits
Competitive salary with performance-based bonusPrivate medical insurance & pension schemeCareer development pathway with leadership trainingFlexible hybrid working (2–3 days office-based)Opportunity to manage global, multi-centre trials