Clinical Trial Manager
Posted 12 hours 27 minutes ago by University Hospitals Sussex NHS Foundation Trust
Permanent
Full Time
Healthcare & Medical Jobs
Sussex, Brighton, United Kingdom, BN1 1
Job Description
View all our vacancies across our hospitals in Sussex. Search, find and apply for a job with us today.
This post is only open to internal applicants.
Clinical Trial Manager NHS AfC: Band 6 Main area Clinical Trial Manager Grade NHS AfC: Band 6 Contract Permanent Hours Full time - 37.5 hours per week Job ref 380-APR25
Employer 279 University Hospitals Sussex NHS Foundation Trust Employer type NHS Site NHS Jobs Town Brighton Salary £37,338 - £44,962 per annum Salary period Yearly Closing 11/05/:59
About our Trust
At UHSussex we're proud to be at the heart of the NHS. As one of the UK's largest acute Trusts , we're a leading example of the excellence, the ambition and the values that have embodied the NHS for over 70 years.
Our hard-working, talented and dedicated people work together towards a common goal - to always put our Patient First . In fact our mission is summed up by our 'where better never stops' motto and you will play a part in driving us forwards and in improving the lives of patients across Sussex.
At UHSussex, diversity is our strength, and we want you to feel included to help us always put the Patient First. Your uniqueness and experiences will be part of our creative and innovative community where everyone is encouraged to succeed. We have a range of Staff Networks to help break down barriers, and can offer a buddy to help new members settle in. We're proud to be a Disability Confident Employer (Level 2) and a Veteran Aware Trust.
We treat our patients and staff with the same compassion and empathy we expect for ourselves. We're here for them when they need us, and we go above and beyond to meet their needs. This can be seen in ourWellbeing Programme for staff which is extensive and designed to support you when you need it, including where possible, flexible working to support work life balance - because we know that to look after others we must first look after ourselves.
As a university trust and a leader in healthcare research, we value learning, teaching and training so that we can be the best that we can be. From the moment you start with us and throughout your career we will help you to grow and develop. We hope that in choosing UHSussex you are choosing a long and happy career where you will be able to see the difference you make and feel valued for all that you do.
We look forward to receiving your application and the start of your journey with UHSussex.
Job overview The post holder will sit in the Trust research Quality Assurance and Trial Management Team and provide trial management support for clinical trials sponsored by the Trust.
Depending on the type, complexity and stage of the studies the post holder may manage one or more studies to ensure they are completed on time, to target, within budget, and in-line with regulatory requirements and good clinical practice. All tasks between study set-up to data-lock come under the responsibility of the trial manager including all quality assurance processes.
The post holder will be expected to work closely with the Chief Investigator, Senior Clinical Trial Manager and QA team to ensure that trials are delivered to standards detailed in the Trust's SOPs.
The post will require working with external NHS sites that are recruiting to the Trust's sponsored trials and external collaborators such as research councils, charities, and Universities. There may be the need to undertake site visits nationally for multi-site trials .
Your remit will additionally involve the development, implementation and maintenance of efficient research management processes to support efficient trial management and reporting. This will include study progress and recruitment status reporting, safety and adverse events management. You will also be tasked with trouble shooting, developing and instigating recovery plans if the project is not running according to plan .
Main duties of the job Responsible for ensuring that clinical trials sponsored by the Trust are set up and conducted according to ICH GCP and other relevant national laws policies and procedures.
Responsible to the Chief Investigator for maintaining oversight of the overall conduct and performance of sponsored trials. This will include identifying significant problems with the conduct of studies and taking remedial action as necessary.
Monitor performance metrics for trials.
Lead on assessing the feasibility of sites taking on new studies by consulting with all relevant parties
Work in collaboration with multidisciplinary teams to provide expertise in the assessment, planning, implementation and evaluation of clinical research protocols.
Analyse and make definitive judgements on complex non-clinical aspects of research study issues, to plan the most efficient way to achieve study setup and delivery.
Support the preparation of clinical trial documentation for HRA, Ethics and Trust approval.
Initiate, implement and maintain a system to track activity in order to manage payments for research studies.
Working for our organisation At UHSussex, diversity is our strength, and we want you to feel included to help us always put the Patient First. Your uniqueness and experiences will be part of our creative and innovative community where everyone is encouraged to succeed. We have a range of Staff Networks to help break down barriers, and can offer a buddy to help new members settle in. We're proud to be a Disability Confident Employer (Level 2) and a Veteran Aware Trust.
We treat our patients and staff with the same compassion and empathy we expect for ourselves. We're here for them when they need us, and we go above and beyond to meet their needs. This can be seen in ourWellbeing Programme for staff which is extensive and designed to support you when you need it, including where possible, flexible working to support work life balance - because we know that to look after others we must first look after ourselves.
As a university trust and a leader in healthcare research, we value learning, teaching and training so that we can be the best that we can be. From the moment you start with us and throughout your career we will help you to grow and develop. We hope that in choosing UHSussex you are choosing a long and happy career where you will be able to see the difference you make and feel valued for all that you do.
We look forward to receiving your application and the start of your journey with UHSussex.
Detailed job description and main responsibilities Responsible for ensuring that clinical trials sponsored by the Trust are set up and conducted according to ICH GCP and other relevant national laws policies and procedures.
Responsible to the Chief Investigator for maintaining oversight of the overall conduct and performance of sponsored trials. This will include identifying significant problems with the conduct of studies and taking remedial action as necessary.
Monitor performance metrics for trials.
Lead on assessing the feasibility of sites taking on new studies by consulting with all relevant parties
Work in collaboration with multidisciplinary teams to provide expertise in the assessment, planning, implementation and evaluation of clinical research protocols.
Analyse and make definitive judgments on complex non-clinical aspects of research study issues, to plan the most efficient way to achieve study setup and delivery.
Support the preparation of clinical trial documentation for HRA, Ethics and Trust approval.
Initiate, implement and maintain a system to track activity in order to manage payments for research studies.
Assist the Senior Management Team in business planning for the QA and sponsorship team.
Lead on performance management activities for delegated clinical trials which include ensuring appropriate reporting of study recruitment to time and target, serious breaches, premature closure of studies and implementing corrective and preventive actions.
Produce progress reports on trials as necessary under the direction of lead investigators.
In the event of a statutory inspection assist in preparing appropriate documentation and making necessary arrangements for the inspection in conjunction with the relevant Trust departments.
Assist the senior management team in the development and implementation of policies and strategies which impact on other areas.
Trial Management Meetings
The post holder is responsible for ensuring the effective management of the trail management and data safety meetings, including the timely distribution of papers.
Attend Senior Team Meetings and ensure regular updates are made on study progress
Where appropriate represent the Trust at external meetings and groups.
Communication
To ensure good communication lines and flows are in place with all collaborators working on the trial. This will include investigators across the NHS (and potentially Europe) to ensure the effective delivery of research studies.
To ensure that there are high standards of documentation and care planning in all areas of practice and that documentation standards are consistent across all areas. Ensuring there are regular reviews of all documentation, and focused action plans are produced when areas of concern are identified.
Ensure that there are systems in place to capture feedback from researchers, partners and funders.
Disseminate protocol information and amendments to members of the research teams as relevant and inline with national guidelines.
Act as a primary point of contact for specific trials.
. click apply for full job details
This post is only open to internal applicants.
Clinical Trial Manager NHS AfC: Band 6 Main area Clinical Trial Manager Grade NHS AfC: Band 6 Contract Permanent Hours Full time - 37.5 hours per week Job ref 380-APR25
Employer 279 University Hospitals Sussex NHS Foundation Trust Employer type NHS Site NHS Jobs Town Brighton Salary £37,338 - £44,962 per annum Salary period Yearly Closing 11/05/:59
About our Trust
At UHSussex we're proud to be at the heart of the NHS. As one of the UK's largest acute Trusts , we're a leading example of the excellence, the ambition and the values that have embodied the NHS for over 70 years.
Our hard-working, talented and dedicated people work together towards a common goal - to always put our Patient First . In fact our mission is summed up by our 'where better never stops' motto and you will play a part in driving us forwards and in improving the lives of patients across Sussex.
At UHSussex, diversity is our strength, and we want you to feel included to help us always put the Patient First. Your uniqueness and experiences will be part of our creative and innovative community where everyone is encouraged to succeed. We have a range of Staff Networks to help break down barriers, and can offer a buddy to help new members settle in. We're proud to be a Disability Confident Employer (Level 2) and a Veteran Aware Trust.
We treat our patients and staff with the same compassion and empathy we expect for ourselves. We're here for them when they need us, and we go above and beyond to meet their needs. This can be seen in ourWellbeing Programme for staff which is extensive and designed to support you when you need it, including where possible, flexible working to support work life balance - because we know that to look after others we must first look after ourselves.
As a university trust and a leader in healthcare research, we value learning, teaching and training so that we can be the best that we can be. From the moment you start with us and throughout your career we will help you to grow and develop. We hope that in choosing UHSussex you are choosing a long and happy career where you will be able to see the difference you make and feel valued for all that you do.
We look forward to receiving your application and the start of your journey with UHSussex.
Job overview The post holder will sit in the Trust research Quality Assurance and Trial Management Team and provide trial management support for clinical trials sponsored by the Trust.
Depending on the type, complexity and stage of the studies the post holder may manage one or more studies to ensure they are completed on time, to target, within budget, and in-line with regulatory requirements and good clinical practice. All tasks between study set-up to data-lock come under the responsibility of the trial manager including all quality assurance processes.
The post holder will be expected to work closely with the Chief Investigator, Senior Clinical Trial Manager and QA team to ensure that trials are delivered to standards detailed in the Trust's SOPs.
The post will require working with external NHS sites that are recruiting to the Trust's sponsored trials and external collaborators such as research councils, charities, and Universities. There may be the need to undertake site visits nationally for multi-site trials .
Your remit will additionally involve the development, implementation and maintenance of efficient research management processes to support efficient trial management and reporting. This will include study progress and recruitment status reporting, safety and adverse events management. You will also be tasked with trouble shooting, developing and instigating recovery plans if the project is not running according to plan .
Main duties of the job Responsible for ensuring that clinical trials sponsored by the Trust are set up and conducted according to ICH GCP and other relevant national laws policies and procedures.
Responsible to the Chief Investigator for maintaining oversight of the overall conduct and performance of sponsored trials. This will include identifying significant problems with the conduct of studies and taking remedial action as necessary.
Monitor performance metrics for trials.
Lead on assessing the feasibility of sites taking on new studies by consulting with all relevant parties
Work in collaboration with multidisciplinary teams to provide expertise in the assessment, planning, implementation and evaluation of clinical research protocols.
Analyse and make definitive judgements on complex non-clinical aspects of research study issues, to plan the most efficient way to achieve study setup and delivery.
Support the preparation of clinical trial documentation for HRA, Ethics and Trust approval.
Initiate, implement and maintain a system to track activity in order to manage payments for research studies.
Working for our organisation At UHSussex, diversity is our strength, and we want you to feel included to help us always put the Patient First. Your uniqueness and experiences will be part of our creative and innovative community where everyone is encouraged to succeed. We have a range of Staff Networks to help break down barriers, and can offer a buddy to help new members settle in. We're proud to be a Disability Confident Employer (Level 2) and a Veteran Aware Trust.
We treat our patients and staff with the same compassion and empathy we expect for ourselves. We're here for them when they need us, and we go above and beyond to meet their needs. This can be seen in ourWellbeing Programme for staff which is extensive and designed to support you when you need it, including where possible, flexible working to support work life balance - because we know that to look after others we must first look after ourselves.
As a university trust and a leader in healthcare research, we value learning, teaching and training so that we can be the best that we can be. From the moment you start with us and throughout your career we will help you to grow and develop. We hope that in choosing UHSussex you are choosing a long and happy career where you will be able to see the difference you make and feel valued for all that you do.
We look forward to receiving your application and the start of your journey with UHSussex.
Detailed job description and main responsibilities Responsible for ensuring that clinical trials sponsored by the Trust are set up and conducted according to ICH GCP and other relevant national laws policies and procedures.
Responsible to the Chief Investigator for maintaining oversight of the overall conduct and performance of sponsored trials. This will include identifying significant problems with the conduct of studies and taking remedial action as necessary.
Monitor performance metrics for trials.
Lead on assessing the feasibility of sites taking on new studies by consulting with all relevant parties
Work in collaboration with multidisciplinary teams to provide expertise in the assessment, planning, implementation and evaluation of clinical research protocols.
Analyse and make definitive judgments on complex non-clinical aspects of research study issues, to plan the most efficient way to achieve study setup and delivery.
Support the preparation of clinical trial documentation for HRA, Ethics and Trust approval.
Initiate, implement and maintain a system to track activity in order to manage payments for research studies.
Assist the Senior Management Team in business planning for the QA and sponsorship team.
Lead on performance management activities for delegated clinical trials which include ensuring appropriate reporting of study recruitment to time and target, serious breaches, premature closure of studies and implementing corrective and preventive actions.
Produce progress reports on trials as necessary under the direction of lead investigators.
In the event of a statutory inspection assist in preparing appropriate documentation and making necessary arrangements for the inspection in conjunction with the relevant Trust departments.
Assist the senior management team in the development and implementation of policies and strategies which impact on other areas.
Trial Management Meetings
The post holder is responsible for ensuring the effective management of the trail management and data safety meetings, including the timely distribution of papers.
Attend Senior Team Meetings and ensure regular updates are made on study progress
Where appropriate represent the Trust at external meetings and groups.
Communication
To ensure good communication lines and flows are in place with all collaborators working on the trial. This will include investigators across the NHS (and potentially Europe) to ensure the effective delivery of research studies.
To ensure that there are high standards of documentation and care planning in all areas of practice and that documentation standards are consistent across all areas. Ensuring there are regular reviews of all documentation, and focused action plans are produced when areas of concern are identified.
Ensure that there are systems in place to capture feedback from researchers, partners and funders.
Disseminate protocol information and amendments to members of the research teams as relevant and inline with national guidelines.
Act as a primary point of contact for specific trials.
. click apply for full job details