Job summary
The Christie NHS Foundation Trust is one of the largest cancer treatment centres in Europe, and an international leader in cancer research and innovation.
We are currently looking for a Translational Research Portfolio Support Manager to join our Experimental Cancer Medicine Team. This is an exciting opportunity to lead the team of Translational Research Facilitators who are responsible for the co-ordination, planning, collection, tracking and initial processing of tissue and bodily fluids for early phase clinical trials and translational research projects within the ECMT.
Applicants must have experience of line management, be qualified to at least scientific degree level, or have an equivalent level of experience, and have knowledge of the Human Tissue Act 2004 and GCP.
The successful candidate will need to demonstrate significant knowledge and experience of the clinical trials process, particularly with regards to translational research. They must have the ability to work proactively and autonomously, and have a strong understanding of the importance of maintaining effective quality oversight within translational research.
Informal discussions are encouraged.
Main duties of the job
The post holder will support the management and oversight of the Translational Research Facilitator functions within the Experimental Cancer Medicine Team.
The post holder will:
- Provide line management support and leadership for the team of Translational Research Facilitators.
- Ensure the efficient and timely initiation and delivery of translational research projects within ECMT, supporting with the identification and management of any requirements specific to translational processes.
- Ensure the efficient and timely collection, processing and shipment of research samples in accordance with individual trial requirements and HTA.
- Ensure the implementation, standardisation and optimisation of data systems for data collection and accurate sample tracking.
- Ensure the application of robust quality management principles across all translational research and sample-handling activities, including adherence to SOPs, audit readiness, accurate documentation and continuous improvement of processes.
- Support divisional activity and performance reporting.
The post holder will work with the ECMT Research Manager, MCRC Biobank Quality and Laboratory Manager and other senior managers to support the identification and delivery of quality improvement and other projects across the team and wider division as required.
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
DUTIES AND RESPONSIBILITIES
LEADERSHIP AND MANAGEMENT
- To provide direct line management for Translational Research Facilitator (TRF) staff within the Experimental Cancer Medicine Team.
- Overall managerial responsibility for recruitment, retention, disciplinary and grievance, and all human resource related staffing issues for the TRF team.
- Ensure the annual performance review and identification of development needs are conducted in accordance with Trust policy.
- 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 and contribute to the continued training and development of nonclinical staff across the Research Division, in relation to Translational Research.
TRANSLATIONAL RESEARCH TRIALS MANAGEMENT
- Act as a pivotal point of contact for Investigators, study sponsors and other relevant parties in relation to translational research studies running within the ECMT.
- Provide guidance to Investigators during set up and throughout the study in relation to sample handling and data collection requirements for Investigator led trials.
- Be responsible for developing and implementing processes to ensure safe and efficient handling of samples according to protocol and regulations.
- Work with ECMT Investigators, providing advice into the development of translational research, including protocol development and grant applications.
- Implement and ensure maintenance of systems to track the status of the translational research portfolio to support monitoring of the delivery of projects and supporting any key business related decisions within the ECMT.
- Be responsible for overall workload management within the TRF team, ensuring cross cover is maintained and flexibility allowing for frequent last minute changes to patient schedules and sample collection requirements.
- Be responsible for ensuring data capture mechanisms are completed efficiently and effectively within agreed timeframes.
- Be responsible for team reporting mechanisms to measure data capture/ entry against agreed performance metrics.
- Work with members of the Molecular Tumour Board to maintain/ further develop reporting of molecular results for patients on translational research studies within the ECMT.
- Be responsible for reporting mechanisms to measure turnaround times of sample retrieval/ shipment from and to required destinations as required per protocol.
- Development and delivery 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.
- Provide expertise at the point of trial feasibility and assessment of resource requirements.
- In conjunction with the ECMT Research Manager collate and provide relevant information relating to the capabilities of the assigned team in preparation for strategic partnership meetings.
- Ensure the TRF team is aware of the archiving process for all clinical trials, ensuring adherence to the current Trust archiving guidelines.
- Maintaining in-house team LIMS system, developing additional functionality in accordance with data collection and sample collection requirements.
- Responsible for developing processes to ensure the completion, quality and integrity of data collected within in-house LIMS system. This will require data interrogation/ data quality checks.
QUALITY AND SERVICE DEVELOPMENT
- Work collaboratively with the ECMT Research Manager, the MCRC Biobank Quality and Laboratory Manager, the Translational Programme Lead, and Research Quality and Regulatory Compliance Team to ensure that quality systems, governance expectations, and agreed ways of working are consistently implemented, embedded, and maintained across the team.
- Build and maintain effective internal and external relationships to support timely and accurate retrieval, handling and transfer of research samples, ensuring pathways are efficient, compliant, and aligned with the required minimum governance standards.
- Conduct scheduled and adhoc internal audits of TRF activity, ensuring compliance with HTA, GCP and local SOPs, documenting findings, and driving corrective and preventative actions.
- Lead proactive monitoring of quality and operational performance within the TRF team. This includes maintaining and regularly reviewing a Quality Management Plan for ECMT, triangulating information from audits, error logs, training records, and competency assessments to identify trends, risks or training gaps.
- Identify concerns early and respond effectively, taking ownership of corrective and preventative actions (CAPAs), escalating issues to senior staff where appropriate, and ensuring learning is embedded into routine practice.
- Exercise a high level of initiative and independent judgement, planning and prioritising workload effectively while working within established protocols and SOPs. The postholder is expected to recognise when issues fall outside existing guidance and to seek advice from the ECMT Research Manager and MCRC Biobank Quality Manager as needed.
- Lead or participate in designated projects on behalf of the ECMT Research Manager, particularly those relating to quality improvement, sample governance, digital systems, or harmonisation of processes across research delivery teams.
TRAINING AND EDUCATION
- The post-holder will oversee induction training, support and mentoring for new non-clinical post holders within the TRF team, and will be responsible for regular review of staff competencies to ensure TRF staff are fully trained and up to date with relevant SOPs, policies and regulations.
- Support and contribute to the education and training needs of the TRF team, ensuring the objectives of the organisation are reflected.
- Provide hands on training for blood or tissue sample handling, including the use of specialist equipment, i.e centrifuge, freezers.
- Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate. Disseminate information to ECMT or research division as appropriate.
- The post holder will have knowledge of the Human Tissue Act (2004) and will provide specialist knowledge to Investigators, researchers, Translational Research Facilitators as appropriate in relation to the Human Tissue Act (2004) ensuring studies running within the ECMT comply.
Job description
Job responsibilities
DUTIES AND RESPONSIBILITIES
LEADERSHIP AND MANAGEMENT
- To provide direct line management for Translational Research Facilitator (TRF) staff within the Experimental Cancer Medicine Team.
- Overall managerial responsibility for recruitment, retention, disciplinary and grievance, and all human resource related staffing issues for the TRF team.
- Ensure the annual performance review and identification of development needs are conducted in accordance with Trust policy.
- 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 and contribute to the continued training and development of nonclinical staff across the Research Division, in relation to Translational Research.
TRANSLATIONAL RESEARCH TRIALS MANAGEMENT
- Act as a pivotal point of contact for Investigators, study sponsors and other relevant parties in relation to translational research studies running within the ECMT.
- Provide guidance to Investigators during set up and throughout the study in relation to sample handling and data collection requirements for Investigator led trials.
- Be responsible for developing and implementing processes to ensure safe and efficient handling of samples according to protocol and regulations.
- Work with ECMT Investigators, providing advice into the development of translational research, including protocol development and grant applications.
- Implement and ensure maintenance of systems to track the status of the translational research portfolio to support monitoring of the delivery of projects and supporting any key business related decisions within the ECMT.
- Be responsible for overall workload management within the TRF team, ensuring cross cover is maintained and flexibility allowing for frequent last minute changes to patient schedules and sample collection requirements.
- Be responsible for ensuring data capture mechanisms are completed efficiently and effectively within agreed timeframes.
- Be responsible for team reporting mechanisms to measure data capture/ entry against agreed performance metrics.
- Work with members of the Molecular Tumour Board to maintain/ further develop reporting of molecular results for patients on translational research studies within the ECMT.
- Be responsible for reporting mechanisms to measure turnaround times of sample retrieval/ shipment from and to required destinations as required per protocol.
- Development and delivery 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.
- Provide expertise at the point of trial feasibility and assessment of resource requirements.
- In conjunction with the ECMT Research Manager collate and provide relevant information relating to the capabilities of the assigned team in preparation for strategic partnership meetings.
- Ensure the TRF team is aware of the archiving process for all clinical trials, ensuring adherence to the current Trust archiving guidelines.
- Maintaining in-house team LIMS system, developing additional functionality in accordance with data collection and sample collection requirements.
- Responsible for developing processes to ensure the completion, quality and integrity of data collected within in-house LIMS system. This will require data interrogation/ data quality checks.
QUALITY AND SERVICE DEVELOPMENT
- Work collaboratively with the ECMT Research Manager, the MCRC Biobank Quality and Laboratory Manager, the Translational Programme Lead, and Research Quality and Regulatory Compliance Team to ensure that quality systems, governance expectations, and agreed ways of working are consistently implemented, embedded, and maintained across the team.
- Build and maintain effective internal and external relationships to support timely and accurate retrieval, handling and transfer of research samples, ensuring pathways are efficient, compliant, and aligned with the required minimum governance standards.
- Conduct scheduled and adhoc internal audits of TRF activity, ensuring compliance with HTA, GCP and local SOPs, documenting findings, and driving corrective and preventative actions.
- Lead proactive monitoring of quality and operational performance within the TRF team. This includes maintaining and regularly reviewing a Quality Management Plan for ECMT, triangulating information from audits, error logs, training records, and competency assessments to identify trends, risks or training gaps.
- Identify concerns early and respond effectively, taking ownership of corrective and preventative actions (CAPAs), escalating issues to senior staff where appropriate, and ensuring learning is embedded into routine practice.
- Exercise a high level of initiative and independent judgement, planning and prioritising workload effectively while working within established protocols and SOPs. The postholder is expected to recognise when issues fall outside existing guidance and to seek advice from the ECMT Research Manager and MCRC Biobank Quality Manager as needed.
- Lead or participate in designated projects on behalf of the ECMT Research Manager, particularly those relating to quality improvement, sample governance, digital systems, or harmonisation of processes across research delivery teams.
TRAINING AND EDUCATION
- The post-holder will oversee induction training, support and mentoring for new non-clinical post holders within the TRF team, and will be responsible for regular review of staff competencies to ensure TRF staff are fully trained and up to date with relevant SOPs, policies and regulations.
- Support and contribute to the education and training needs of the TRF team, ensuring the objectives of the organisation are reflected.
- Provide hands on training for blood or tissue sample handling, including the use of specialist equipment, i.e centrifuge, freezers.
- Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate. Disseminate information to ECMT or research division as appropriate.
- The post holder will have knowledge of the Human Tissue Act (2004) and will provide specialist knowledge to Investigators, researchers, Translational Research Facilitators as appropriate in relation to the Human Tissue Act (2004) ensuring studies running within the ECMT comply.
Person Specification
Qualifications
Essential
- Scientific/ Business degree or relevant experience in scientific and medical research, including Translational 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 translational research coordination 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
- Experience of conducting audits and being involved in service improvement initiatives
- Post-graduate administration/ business experience
Skills
Essential
- Relevant experience working in a laboratory environment/ biobanking experience
- 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, specifically of the Human Tissue Act 2004
- 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
- Knowledge of quality management systems
VALUES
Essential
- Ability to demonstrate the organisational values and behaviours
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, including Translational 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 translational research coordination 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
- Experience of conducting audits and being involved in service improvement initiatives
- Post-graduate administration/ business experience
Skills
Essential
- Relevant experience working in a laboratory environment/ biobanking experience
- 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, specifically of the Human Tissue Act 2004
- 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
- Knowledge of quality management systems
VALUES
Essential
- Ability to demonstrate the organisational values and behaviours
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.
