Job summary
The primary purpose of this post is to promote and facilitate the delivery of high quality research activity within London Northwest University Healthcare NHS Trust ("the Trust") and to ensure that all such research is conducted in full compliance with Research Governance standards and other statutory obligations.
The Research Operations & Governance Manager will be responsible for providing operational leadership to ensure that LNWH delivers high quality research for improved patient care and achieves performance objectives for initiating and delivering clinical research. This position will focus on ensuring systems, processes, and workflows of LNWH are consistent with the Trust's strategic initiatives and on improving clinical research management organizational practices including research governance systems, to ensure that the Trust complies fully with the requirements of the Department of Health & Social Care's UK Policy Framework for Health & Social Care Research, Clinical Trial Regulations and the EU clinical trials directives. The Research Operations & Governance Manager will promote and develop a research culture that supports high quality research through help and support to clinical researchers by building collaborative relationships with partner organizations, identifying synergies and acting as a point of contact for clinical research operations and governance.
Main duties of the job
- Responsible for Initiating and driving an innovative programme of clinical research management improvement projects, whilst maintaining documentary evidence of governance compliance and ensuring organisational compliance with all aspects Trust research including the management and resolution of non-compliance issues in line with Trust policy.
Ensure and develop Standard Operating Procedures (SOPs) and other related documents associated with Sponsorship and delivery are in place and reflect national and local policies and regulatory requirements.
- Manage the development of system which enable the recording and tracking of research approval and delivery timelines in accordance with institutional and national requirements
Maintain knowledge of the UK Policy Framework for Health and Social Care Research and other R&I processes and updating local and public information regularly for example reviewing websites, bulletins, e-mails etc
Responsible for Initiating and driving an innovative programme of clinical research management improvement projects, whilst maintaining documentary evidence of governance compliance and ensuring organisational compliance with all aspects Trust research including the management and resolution of non-compliance issues in line with Trust policy.
About us
London North West University Healthcare NHS Trust (LNWH) cares for the people of Brent, Ealing, Harrow and beyond.
Our team of more than 8,200 clinical and support staff serve a diverse population of almost one million people.
We run major acute services at:
o Northwick Park Hospital: home to one of the busiest emergency departments (A&E) in the country. The hospital provides a full range of services including the country's top-rated hyper-acute stroke unit and one of only three hyper-acute rehabilitation units in the UK
o St Mark's Hospital: an internationally renowned specialist centre for bowel disease
o Ealing Hospital: a busy district general hospital providing a range of clinical services, as well as 24/7 emergency department and urgent care centre, and specialist care at Meadow House Hospice
o Central Middlesex Hospital: our planned care site, hosting a range of surgical and outpatient services and collocated with an urgent care centre.
We are a university teaching NHS trust, in recognition of the important role we play in training clinicians of the future and bringing the benefits of research to the public.
Job description
Job responsibilities
To view the main responsibility, please see the attached the Job Description and Person Specification.
Job description
Job responsibilities
To view the main responsibility, please see the attached the Job Description and Person Specification.
Person Specification
Essential
Essential
- 1.Educated to degree level 2.Higher degree in relevant discipline such as medical law and ethics, Masters or equivalent experience
Desirable
- o Formal training in ICH GCP oProject management qualification
Essential
Essential
- 1.Knowledge of UK policy framework for Health and Social Care Research, NHS R&D strategy, NHS long term plan and national industrial strategies etc. 2.Thorough knowledge of legal framework around research governance including national and international regulations and legislation. 3.Highly developed specialist knowledge of health service, Good Clinical Practice (GCP), clinical research and clinical trials management underpinned by theoretical knowledge and practical experience 4.Experience in developing and implementing policy, guidelines and projects from initiation to completion 5.Significant research management experience at a senior level within a scientific or clinical research environment6.Ability to communicate highly complex, sensitive or contentious information orally and in writing, both internally and externally, to a range of audiences 7.Ability to work in an independent manner with proven organizational skills and ability to plan ahead, set priorities and work to deadlines taking into account the needs and priorities of others 8.Ability to handle analyse and interpret complex information and rationalise data 9.Lead on change management, performance improvement and provide effective leadership
- 1.Proven leadership skills at a senior level, including the management, development and maintaining high standards of research quality 2.Ability to build and sustain relationships with a wide range of external stakeholders, NHS staff, from all professions, undertaking research 3.Excellent communication, diplomatic and organisational skills including negotiation, with the proven ability to liaise and engage effectively within a multidisciplinary team based environment 4.Excellent skills in developing and improving governance, operational administrative systems 5.Excellent computer skills (familiarity with Microsoft Office software, databases, statistical packages, etc.) to utilise information technology to produce management information reports; creation and maintenance of databases; presentations
Desirable
- oKnowledge of innovation and intellectual property
- oSkills in developing learning, eg through teaching or professional development
Person Specification
Essential
Essential
- 1.Educated to degree level 2.Higher degree in relevant discipline such as medical law and ethics, Masters or equivalent experience
Desirable
- o Formal training in ICH GCP oProject management qualification
Essential
Essential
- 1.Knowledge of UK policy framework for Health and Social Care Research, NHS R&D strategy, NHS long term plan and national industrial strategies etc. 2.Thorough knowledge of legal framework around research governance including national and international regulations and legislation. 3.Highly developed specialist knowledge of health service, Good Clinical Practice (GCP), clinical research and clinical trials management underpinned by theoretical knowledge and practical experience 4.Experience in developing and implementing policy, guidelines and projects from initiation to completion 5.Significant research management experience at a senior level within a scientific or clinical research environment6.Ability to communicate highly complex, sensitive or contentious information orally and in writing, both internally and externally, to a range of audiences 7.Ability to work in an independent manner with proven organizational skills and ability to plan ahead, set priorities and work to deadlines taking into account the needs and priorities of others 8.Ability to handle analyse and interpret complex information and rationalise data 9.Lead on change management, performance improvement and provide effective leadership
- 1.Proven leadership skills at a senior level, including the management, development and maintaining high standards of research quality 2.Ability to build and sustain relationships with a wide range of external stakeholders, NHS staff, from all professions, undertaking research 3.Excellent communication, diplomatic and organisational skills including negotiation, with the proven ability to liaise and engage effectively within a multidisciplinary team based environment 4.Excellent skills in developing and improving governance, operational administrative systems 5.Excellent computer skills (familiarity with Microsoft Office software, databases, statistical packages, etc.) to utilise information technology to produce management information reports; creation and maintenance of databases; presentations
Desirable
- oKnowledge of innovation and intellectual property
- oSkills in developing learning, eg through teaching or professional development
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).
