Job summary
Please note that this post is offered as a permanent contract at 30-37.5 h/week.
An exciting opportunity has arisen within the Research and Innovation Division at The Christie. We are looking to appoint a Research Portfolio Manager to the Melanoma research delivery team within The Christie NHS Foundation Trust.
We are seeking enthusiastic and highly motivated individuals, who are able to demonstrate significant work experience in clinical trials coordination and data management involving clinical trials or project co-ordination, as well as a good understanding of clinical research, GCP and clinical governance.
We are looking for individuals with excellent organisation and communication skills, who can work well both in a team and using their own initiative. The individuals must demonstrate good leadership skills that will promote an environment of quality and learning.
The role is ideal for individuals to build upon line management and leadership experience in clinical trials coordination. It is tailored to equip the successful candidates with the necessary skills and experience to become a future leader in this field.
Applicants should meet all the essential criteria described in the job description as a minimum, including holding a scientific or business-based degree, or have relevant experience in scientific and medical research.
Main duties of the job
The focus of this roles is to provide support to sustain and improve an excellent level of service provision from a trial site perspective for our research partners. In order to support our growth as a centre of excellence in research, a tailored training programme will be provided to the successful candidates to consolidate the skills required to provide management and leadership in the Melanoma Research Team.
Opportunities will be available to lead service development projects within the team and the wider R&I division.
We are looking for an individual who will act as a key co-ordinator for the Melanoma Research team to proactively ensure the provision of a high quality and efficient administrative service.
The roles will involve aspects of work allocation and support of coordination staff with direct line management, oversight of team metrics, set up of new trials and coordination of ongoing trials. Workload assignment will vary and not all aspects of the job description will be performed.
The post holders will be expected to provide support to the senior R&I management and clinical research staff, and ensure compliance with Trust Policy, Good Clinical Practice (GCP) and all other relevant requirements.
About us
The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country. We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years. We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.
Job description
Job responsibilities
LEADERSHIP AND MANAGEMENT
- To provide direct line management for research coordination and administrative staff within a designated team.
- Overall managerial responsibility for recruitment, retention, disciplinary and grievance, and all human resource related staffing issues for the assigned team.
- Ensure the annual performance review and identification of development needs are conducted in accordance with Trust policy.
- Supportand contribute to the education and training needs of the research teams, ensuring the objectives of the organisation are reflected.
- Contribute to the assessment and allocation of the workforce requirements to support the effective maintenance and management of the portfolio of research within the designated team.
- Provide leadership within the team and act as a role model and resource for all team members.
- Maintain own professional development and identify learning needs and opportunities.
- Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.
- Oversee induction training, support and mentoring for new non-clinical post holders within the team.
- Participate and lead on continued training and development of non-clinical staff across the Research Division
FINANCIAL MANAGEMENT
- Support contract negotiation processes with trial sponsors under direction from the Clinical Research Nurse Team Leader/ Research Manager, ensuring appropriate financial agreements are in place for each project for both commercial and Trust- sponsored (i.e. investigator-led) research.
- Ensure the business processes and systems for financial management are implemented, such as, service line reporting, invoicing, procurement, activity logs etc.
- Adopt responsive working practices in relation to any new financial processes/ systems that require implementation.
- Produce written activity and annual reports under the direction of the Clinical Research Nurse Team Leaders
CLINICAL TRIALS MANAGEMENT
- Act as a pivotal point of contact with the pharmaceutical companies, study sponsor, MAHSC-Clinical Trials Coordination Unit and clinical research associates.
- Under the direction of the Clinical Research Nurse Team Leaders/ Research Manager, be responsible for and may participate in the administrative set-up and on- going administrative management of all clinical trials within the team.
- Implement and ensure maintenance of systems to track the status of the research portfolio to support monitoring of the delivery of projects and supporting any key business related decisions within a designated team.
- Responsible for ensuring clinical report forms and other data capture mechanisms are completed efficiently and effectively within agreed timeframes.
- Development of team reporting mechanisms to measure data capture/ entry against agreed performance metrics.
- Development of action plans to address any actual or potential deviations from agreed data capture metrics.
- Ensure team, divisional and national study targets are achieved within agreed timeframes.
- Liaison with Trust departments regarding trial feasibility and resource requirement In collaboration with the Clinical Research Nurse Team Leader/ Research Manager work in liaison with internal and external sponsors and their representatives to ensure timely collection and management of trial related data
- In conjunction with the Clinical Research Nurse Team Leader/ Research Manager collate and provide relevant information relating to the capabilities of the assigned team in preparation for strategic partnership meetings. Oversee the archiving process for all clinical trials, ensuring adherence to the current Trust archiving guidelines.
QUALITY AND SERVICE DEVELOPMENT
- Working in collaborationwith the Clinical Research Nurse Team Leaders and the divisional quality and improvement teams to ensure that quality systems and new ways of working are implemented and embedded within team practices.
- Be pro-active in monitoring the quality and effectiveness of working practices within research team.
- The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to the Clinical Research Nurse Team Leader/ Research Manager as required. The post holder is guided by relevant protocols, SOPs and expected to exercise judgement outside these areas. However, the Research Divisions managerial team members are available as point of reference for any queries and will meet regularly with staff.
- The post holder is expected to lead on specific projects as designated by the Clinical Research Nurse Team Leader/ Research Manager.
Job description
Job responsibilities
LEADERSHIP AND MANAGEMENT
- To provide direct line management for research coordination and administrative staff within a designated team.
- Overall managerial responsibility for recruitment, retention, disciplinary and grievance, and all human resource related staffing issues for the assigned team.
- Ensure the annual performance review and identification of development needs are conducted in accordance with Trust policy.
- Supportand contribute to the education and training needs of the research teams, ensuring the objectives of the organisation are reflected.
- Contribute to the assessment and allocation of the workforce requirements to support the effective maintenance and management of the portfolio of research within the designated team.
- Provide leadership within the team and act as a role model and resource for all team members.
- Maintain own professional development and identify learning needs and opportunities.
- Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.
- Oversee induction training, support and mentoring for new non-clinical post holders within the team.
- Participate and lead on continued training and development of non-clinical staff across the Research Division
FINANCIAL MANAGEMENT
- Support contract negotiation processes with trial sponsors under direction from the Clinical Research Nurse Team Leader/ Research Manager, ensuring appropriate financial agreements are in place for each project for both commercial and Trust- sponsored (i.e. investigator-led) research.
- Ensure the business processes and systems for financial management are implemented, such as, service line reporting, invoicing, procurement, activity logs etc.
- Adopt responsive working practices in relation to any new financial processes/ systems that require implementation.
- Produce written activity and annual reports under the direction of the Clinical Research Nurse Team Leaders
CLINICAL TRIALS MANAGEMENT
- Act as a pivotal point of contact with the pharmaceutical companies, study sponsor, MAHSC-Clinical Trials Coordination Unit and clinical research associates.
- Under the direction of the Clinical Research Nurse Team Leaders/ Research Manager, be responsible for and may participate in the administrative set-up and on- going administrative management of all clinical trials within the team.
- Implement and ensure maintenance of systems to track the status of the research portfolio to support monitoring of the delivery of projects and supporting any key business related decisions within a designated team.
- Responsible for ensuring clinical report forms and other data capture mechanisms are completed efficiently and effectively within agreed timeframes.
- Development of team reporting mechanisms to measure data capture/ entry against agreed performance metrics.
- Development of action plans to address any actual or potential deviations from agreed data capture metrics.
- Ensure team, divisional and national study targets are achieved within agreed timeframes.
- Liaison with Trust departments regarding trial feasibility and resource requirement In collaboration with the Clinical Research Nurse Team Leader/ Research Manager work in liaison with internal and external sponsors and their representatives to ensure timely collection and management of trial related data
- In conjunction with the Clinical Research Nurse Team Leader/ Research Manager collate and provide relevant information relating to the capabilities of the assigned team in preparation for strategic partnership meetings. Oversee the archiving process for all clinical trials, ensuring adherence to the current Trust archiving guidelines.
QUALITY AND SERVICE DEVELOPMENT
- Working in collaborationwith the Clinical Research Nurse Team Leaders and the divisional quality and improvement teams to ensure that quality systems and new ways of working are implemented and embedded within team practices.
- Be pro-active in monitoring the quality and effectiveness of working practices within research team.
- The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to the Clinical Research Nurse Team Leader/ Research Manager as required. The post holder is guided by relevant protocols, SOPs and expected to exercise judgement outside these areas. However, the Research Divisions managerial team members are available as point of reference for any queries and will meet regularly with staff.
- The post holder is expected to lead on specific projects as designated by the Clinical Research Nurse Team Leader/ Research Manager.
Person Specification
Qualifications
Essential
- Scientific/ Business degree or relevant experience in scientific and medical research.
- Current GCP certification.
Desirable
- Post graduate certificate in clinical research or other relevant post graduate qualification/ experience.
- Management qualification.
Experience
Essential
- Line management experience
- Significant experience in clinical trial administration and co- ordination in the NHS, academic and/ or commercial setting.
- Experience of using a wide range of IT software and data collection applications.
- Experience in managing projects and able to independently deliver projects on target.
Desirable
- Experience of performance monitoring and management.
- Previous experience of working in the NHS.
- Experience in leading/ initiating change
- Post-graduate administration/ business experience.
Skills
Essential
- Excellent interpersonal skills with the ability to negotiate, influence in contentious situations.
- Excellent oral and written communication skills.
- Intermediate level of IT skills.
- Strong leadership skills.
- Effective organisational, prioritisation and time management skills.
- Ability to assimilate complex information.
Desirable
- Ability to manage simultaneously a wide variety of issues and projects
Knowledge
Essential
- In-depth understanding of clinical research process, patient information systems and relevant clinical research relevant standards and legislation.
- Knowledge of medical terminology and oncology.
- Knowledge of external organisations including research partners in the higher education and commercial sectors.
Desirable
- Understanding of cancer biology and different treatment modalities.
- Knowledge of research funding arrangements within the NHS.
Other
Essential
- Ability to work to tight and/ or unexpected deadlines.
- Flexible and adaptable.
- Conscientious and hardworking.
- Ability to work unsupervised or as part of a team.
- Innovative and positive approach with the ability to troubleshoot effectively.
Desirable
- Evidence of CPD.
- Evidence of achievement under pressure.
Person Specification
Qualifications
Essential
- Scientific/ Business degree or relevant experience in scientific and medical research.
- Current GCP certification.
Desirable
- Post graduate certificate in clinical research or other relevant post graduate qualification/ experience.
- Management qualification.
Experience
Essential
- Line management experience
- Significant experience in clinical trial administration and co- ordination in the NHS, academic and/ or commercial setting.
- Experience of using a wide range of IT software and data collection applications.
- Experience in managing projects and able to independently deliver projects on target.
Desirable
- Experience of performance monitoring and management.
- Previous experience of working in the NHS.
- Experience in leading/ initiating change
- Post-graduate administration/ business experience.
Skills
Essential
- Excellent interpersonal skills with the ability to negotiate, influence in contentious situations.
- Excellent oral and written communication skills.
- Intermediate level of IT skills.
- Strong leadership skills.
- Effective organisational, prioritisation and time management skills.
- Ability to assimilate complex information.
Desirable
- Ability to manage simultaneously a wide variety of issues and projects
Knowledge
Essential
- In-depth understanding of clinical research process, patient information systems and relevant clinical research relevant standards and legislation.
- Knowledge of medical terminology and oncology.
- Knowledge of external organisations including research partners in the higher education and commercial sectors.
Desirable
- Understanding of cancer biology and different treatment modalities.
- Knowledge of research funding arrangements within the NHS.
Other
Essential
- Ability to work to tight and/ or unexpected deadlines.
- Flexible and adaptable.
- Conscientious and hardworking.
- Ability to work unsupervised or as part of a team.
- Innovative and positive approach with the ability to troubleshoot effectively.
Desirable
- Evidence of CPD.
- Evidence of achievement under pressure.
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).
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).
