Job summary
We are seeking to appoint to a senior trial manager to lead on the advanced therapy research portfolio and other haemophilia and haematology studies within the centre and provide supervision for the wider research team.
The responsibilities of the post include but are not limited to developing clinical trial protocol and documents for submission to grant bodies, regulators, managing the research team, overseeing the support for studies; developing strategies for the efficient recruitment of patients onto clinical trials, the collection and maintenance of study records and case report forms and publications. An estimated 20% of the role will be people management.
The post holder will work in close collaboration with Chief Investigators, Principal Investigators the Trust R&D Office and the UCL Joint Research Office in developing clinical trial protocols and documents for submission to grant bodies, regulators.
The post holder will be supported by a research team including research nurses, clinical trial practitioners, data managers and lab personnel.
Main duties of the job
We are seeking to appoint to a senior trial manager to lead on the advanced therapy research portfolio and other haemophilia and haematology studies within the centre and provide supervision for the wider research team.
The responsibilities of the post include but are not limited to developing clinical trial protocol and documents for submission to grant bodies, regulators, managing the research team, overseeing the support for studies; developing strategies for the efficient recruitment of patients onto clinical trials, the collection and maintenance of study records and case report forms and publications. An estimated 20% of the role will be people management.
The post holder will work in close collaboration with Chief Investigators, Principal Investigators the Trust R&D Office and the UCL Joint Research Office in developing clinical trial protocols and documents for submission to grant bodies, regulators.
The post holder will be supported by a research team including research nurses, clinical trial practitioners, data managers and lab personnel.
About us
We are seeking to appoint to a senior trial manager to lead on the advanced therapy research portfolio and other haemophilia and haematology studies within the centre and provide supervision for the wider research team.
The responsibilities of the post include but are not limited to developing clinical trial protocol and documents for submission to grant bodies, regulators, managing the research team, overseeing the support for studies; developing strategies for the efficient recruitment of patients onto clinical trials, the collection and maintenance of study records and case report forms and publications. An estimated 20% of the role will be people management.
The post holder will work in close collaboration with Chief Investigators, Principal Investigators the Trust R&D Office and the UCL Joint Research Office in developing clinical trial protocols and documents for submission to grant bodies, regulators.
The post holder will be supported by a research team including research nurses, clinical trial practitioners, data managers and lab personnel.
Job description
Job responsibilities
We are seeking to appoint to a senior trial manager to lead on the advanced therapy research portfolio and other haemophilia and haematology studies within the centre and provide supervision for the wider research team.
The responsibilities of the post include but are not limited to developing clinical trial protocol and documents for submission to grant bodies, regulators, managing the research team, overseeing the support for studies; developing strategies for the efficient recruitment of patients onto clinical trials, the collection and maintenance of study records and case report forms and publications. An estimated 20% of the role will be people management.
The post holder will work in close collaboration with Chief Investigators, Principal Investigators the Trust R&D Office and the UCL Joint Research Office in developing clinical trial protocols and documents for submission to grant bodies, regulators.
The post holder will be supported by a research team including research nurses, clinical trial practitioners, data managers and lab personnel.
Job description
Job responsibilities
We are seeking to appoint to a senior trial manager to lead on the advanced therapy research portfolio and other haemophilia and haematology studies within the centre and provide supervision for the wider research team.
The responsibilities of the post include but are not limited to developing clinical trial protocol and documents for submission to grant bodies, regulators, managing the research team, overseeing the support for studies; developing strategies for the efficient recruitment of patients onto clinical trials, the collection and maintenance of study records and case report forms and publications. An estimated 20% of the role will be people management.
The post holder will work in close collaboration with Chief Investigators, Principal Investigators the Trust R&D Office and the UCL Joint Research Office in developing clinical trial protocols and documents for submission to grant bodies, regulators.
The post holder will be supported by a research team including research nurses, clinical trial practitioners, data managers and lab personnel.
Person Specification
Education & professional Qualifications
Essential
- Relevant first degree
- Evidence of recent professional / management / leadership development
Desirable
- Master's degree or working towards
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Experience
Essential
- Experience of working to UK Clinical Regulations and ICH-GCP and regulatory framework
- Experience of assisting with the development of CRFs and clinical trial databases
- Experienced in oversight of complex clinical trials to include writing of protocols, data management, governance and approval requirements
- Knowledge and experience of leading significant change, delivering tangible and sustained improvements
- Experience of managing employment relation issues
- Financial management skills to include experience of preparing costings for research studies and generation of invoices for completed research studies.
- Knowledge and experience of practice and policy across a broad range of responsibilities, e.g. financial systems & budgetary control, corporate, clinical and research governance, health & safety and human resources
- Experience of study monitoring and or inspections, both regulatory and sponsor
- Experience of developing and implementing new SOPs and processes
- Experience of development of CRFs and clinical trial databases
- Experience of managing staff and improving individuals and team performance
- Able to build rapport and credibility with senior clinical and managerial colleagues
- Experience of working across organisational boundaries with multidisciplinary teams
Desirable
- Experience of developing systems and processes to allow efficient management and conduct of multicentre clinical trials
Skills and aptitudes
Essential
- Excellent written and oral communication skills and experience of communicating effectively with all levels of staff
- To prepare written reports and contribute to business planning and service delivery
- Ability to handle complex information in relation to running of clinical trials and the various regulatory requirements
- In depth understanding of ICH -GCP and competency in delivering related training to research and non -research staff
- In depth knowledge and understanding of the requirements of clinical trials and clinical research projects during their life -cycle
- Knowledge of systems and processes required to conduct clinical trials in accordance with clinical trial regulations
Desirable
- Knowledge of database set -up and data management processes and procedures necessary to conduct clinical trials
Personal Qualities and attributes
Essential
- Highly professional role model
- Ability to work well within a multi -disciplinary environment in an effective and supportive way
- Ability to prioritise workload of others while balancing own workload(s).
- Able to work under pressure, methodical in approach, with effect problem -solving ability
- Continues to advance their specialist knowledge & understanding
- Ability to reflect, question & evaluate own practice
- Willing to work flexibly to include some evening and weekend working.
- Proven problem solving skills
- Ability to negotiate, acting in a tactful and confidence manner to achieve the desired results
- Willing and able to coach and train others
- Excellent presentation skills.
Person Specification
Education & professional Qualifications
Essential
- Relevant first degree
- Evidence of recent professional / management / leadership development
Desirable
- Master's degree or working towards
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Experience
Essential
- Experience of working to UK Clinical Regulations and ICH-GCP and regulatory framework
- Experience of assisting with the development of CRFs and clinical trial databases
- Experienced in oversight of complex clinical trials to include writing of protocols, data management, governance and approval requirements
- Knowledge and experience of leading significant change, delivering tangible and sustained improvements
- Experience of managing employment relation issues
- Financial management skills to include experience of preparing costings for research studies and generation of invoices for completed research studies.
- Knowledge and experience of practice and policy across a broad range of responsibilities, e.g. financial systems & budgetary control, corporate, clinical and research governance, health & safety and human resources
- Experience of study monitoring and or inspections, both regulatory and sponsor
- Experience of developing and implementing new SOPs and processes
- Experience of development of CRFs and clinical trial databases
- Experience of managing staff and improving individuals and team performance
- Able to build rapport and credibility with senior clinical and managerial colleagues
- Experience of working across organisational boundaries with multidisciplinary teams
Desirable
- Experience of developing systems and processes to allow efficient management and conduct of multicentre clinical trials
Skills and aptitudes
Essential
- Excellent written and oral communication skills and experience of communicating effectively with all levels of staff
- To prepare written reports and contribute to business planning and service delivery
- Ability to handle complex information in relation to running of clinical trials and the various regulatory requirements
- In depth understanding of ICH -GCP and competency in delivering related training to research and non -research staff
- In depth knowledge and understanding of the requirements of clinical trials and clinical research projects during their life -cycle
- Knowledge of systems and processes required to conduct clinical trials in accordance with clinical trial regulations
Desirable
- Knowledge of database set -up and data management processes and procedures necessary to conduct clinical trials
Personal Qualities and attributes
Essential
- Highly professional role model
- Ability to work well within a multi -disciplinary environment in an effective and supportive way
- Ability to prioritise workload of others while balancing own workload(s).
- Able to work under pressure, methodical in approach, with effect problem -solving ability
- Continues to advance their specialist knowledge & understanding
- Ability to reflect, question & evaluate own practice
- Willing to work flexibly to include some evening and weekend working.
- Proven problem solving skills
- Ability to negotiate, acting in a tactful and confidence manner to achieve the desired results
- Willing and able to coach and train others
- Excellent presentation skills.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
