Clinical Research Facility Business and Operations Manager

Job description

Job responsibilities

Strategic Development of the CRF:

a) Lead on the development and implementation of a comprehensive operational business plan and business cases as required for additional financial support and resource to both internal and external audiences.

b) Responsible for the development of research functions and future service delivery requirements of the adult CRFs in order to support commercial and non-commercial/academic research studies.

c) Responsible for the development of key performance indicators and metrics including occupancy data in order to ensure accurate reporting of activities to the CRF Directors, BRC and R&D Departments, and the NIHR.

d) Responsible for reporting the CRF metrics nationally to the NIHR in line with the contractual obligations of our NIHR CRF funding, and locally within the CRF, BRC and R&D governance structures.

e) Provide expert advice and information to support the development of key strategic external peer reviewed infrastructure bids relevant to the CRF and the development of the strategic vision for the CRF.

f) Working in conjunction with the adult CRF Nurse Manager, develop and maintain productive working relationships with pharmaceutical companies and the biotechnology industry partners in order to create and sustain the sound business relationships, strategic partnerships and business alliances needed to attract commercial research activities to the CRF.

g) Liaise with multiple external agencies and internal departments to promote and facilitate the establishment of new clinical research studies within the adult facilities.

h) Ensure that participant feedback/complaints are reported, investigated and responded to appropriately in order to improve service delivery developments and patient experience.

i) Contribute to the development of national CRF policies and initiatives through participation in the UK CRF Network and be responsible for dissemination and implementation of national initiatives within the CRF.

j) Responsible for developing strategies to ensure effective collaboration with other BRC Core Facilities such as the Good Manufacturing Practice Unit and the Immune Monitoring and Flow Cytometry cores to allow the seamless transition of research activities between these facilities.

k) Responsible for the strategic working relationship with other CRFs within Kings HealthPartners in order to increase and maximise operational efficiencies where appropriate and to share best practice.

l) Play a lead role as an Executive member of the CRF Management Team, CRF Review Board and Operations meetings as well as BRC Management meetings.

Financial Management

a) Lead on the development of a robust financial plan and cost recovery system for the CRF for both commercial and non-commercial research activity including the generation of income targets and monitoring of activity against such targets.

b) Responsible for management of the adult CRF budget from both the NIHR CRF funding award and the delegated BRC budget, ensuring income capture, adherence to agreed budget plans, identifying savings and costs reduction in conjunction with the relevant Research Management Accountants/Financial Analysts to ensure budgets are up to date and accurate, making adjustments where required.

c) Delegated signatory of up to £5k.

d) Responsible for identifying costs pressures, service development and cost improvement plans and to present data on performance as required.

e) Responsible for the management and maintenance of the CRFs Asset Register on behalf of the BRC and management of any relevant associated service or maintenance contracts.

Facilities Management

a) To be responsible for the ongoing management and maintenance of the building, equipment and facilities, ensuring the CRF provides an environment conducive to supporting high quality clinical research in line with relevant regulatory frameworks.

b) To promptly resolve any unexpected operational problems impacting on service users and safety.

c) To be responsible for the procurement of all new equipment, furniture and fittings and to ensure purchases are underpinned by maintenance contracts where appropriate.

d) To develop and maintain inventories/databases appropriate for good resource management and ensure that systems are in place for safety testing, servicing and maintenance as appropriate.

e) Liaise with the Trusts estates and facilities department and external suppliers in planning and implementing any repairs, improvements or other building works.

f) Develop and implement a security policy for the unit and put systems in place to ensure the ongoing safety and security of staff, children and their families and investigators.

g) Negotiate the annual service level agreements (e.g. the provision of cleaning services) formulated between the CRF and other service departments within the Trust, ensuring they are submitted and reviewed in a timely manner and that value for money is obtained. Act as the primary Health and Safety and Fire representative for the unit, ensuring there is an appropriate H&S structure in place to provide a suitable environment for conducting multi-disciplinary clinical research which is compliant with statutory requirements. Conduct risk analyses as appropriate.

Human Resources

a) Maintain a system of regular performance review and annual appraisals for all staff ensuring training and development needs are identified and met. Ensure appropriate mentors are available to all disciplines of CRF staff.

b) Provide line manage for key CRF staff and lead on recruitment, induction, appraisal, training and development and retention of CRF staff as well as managing sickness and absence, disciplinary and performance issues that may arise.

c) Develop workforce plans which anticipate service changes and developments and which address recruitment, retention and workforce supply issues to minimise the impact of these on service delivery.

d) Lead and support organisational change to ensure efficient service delivery, productivity and compliance with Trust and CRF goals. This could include consultation with staff and promoting new ways of working, implementing new policies and procedures.

Operational Management and Leadership

a) Deputise for the CRF Director, Deputy Director and BRC Platforms Manager as required.

b) Overall responsibility for the day to day operational management of the adult Clinical Research Facilities including operational planning to establish appropriate resources and capacity to deliver the forthcoming pipeline of clinical research in the CRF.

d) In collaboration with the adult CRF Nurse Managers, provide operational leadership ensuring there is a clear framework for the delivery of high quality care and clinical research and that best practice is maintained at all times.

e) Set, monitor, implement and seek to continuously improve adult CRF services in line with MHRA Phase I Accreditation, Good Clinical Practice, Research and Clinical Governance, Health and Safety, Data Protection, Infection Control and Ethics.

f) Ensure that all Trust policies including child protection, vulnerable adult and Human Tissue Act legislation are adhered to by CRF staff.

g) Lead by example and act as a positive role model for all staff, taking responsibility for your own professional development.

h) Maintain personal standards of conduct and behaviour, which are consistent with Trust and professional standards and requirements, ensuring these standards are achieved.

Communication and Networking

a) Responsible for representing the CRF and the BRC at relevant internal and external meetings and conferences (national and international as required).

b) Act as the lead on developing, maintaining and fostering strategic links with other national CRFs and the UK CRF Network including representation at the pan-London CRF Network.

c) Responsible for promoting a positive image of the CRFs at all times especially promoting the CRFs as centres of clinical excellence for undertaking research activities in order to attract new business activities to the facility, both in the academic/NHS arena and the commercial sector.

d) Responsible for promoting the CRF by proactively targeting clinical academics, research groups and organisations, building effective management links and networks with the Clusters within the BRC, Trust departments and the College, in order to ensure efficient management and development of research collaborations in relation to CRF activities.

e) Establish and maintain strong links with surrounding NHS and academic partners particularly Kings College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust within Kings Health Partners.

f) Responsible for developing the patient and public involvement strategy for the CRF in partnership with the BRC, encompassing participation in Trust, UKCRF Network open days, BRC promotional events and also Trust events relating to public engagement in research.

g) Act as the Trust lead in relation to showcasing the CRF in terms of infrastructure facilities and operational management, and provide advice and guidance to external visitors including government and charitable organisations on the development and management of further CRFs across the country.

Educational and Training

a) Facilitate the development of skills in clinical research and ensure training and development opportunities are available to all disciplines of CRF staff.

b) Create and promote an appropriate learning environment across the CRFs.

Person Specification

Qualifications / Education

Essential

• Masters degree or willingness to work towards or equivalent experience
• Evidence of continuing professional development

Desirable

• Management education (Diploma, MBA or equivalent experience)

PRevious Experience

Essential

• Experience of working in a clinical research facility or clinical trials unit.
• Experience of business planning and managing a budget
• A track record in developing clinical research policies particularly in relation to clinical operations, clinical governance, research governance and regulatory requirements for NIHR Phase I Accreditation.
• Expertise in developing and reporting key performance indicators in relation to clinical research, clinical trials, clinical research operations such as occupancy, research outputs and financial data.
• Experience of developing new working relationships/collaborations with a broad range of commercial and non commercial organisations.
• Experience in managing and mentoring technical staff and dealing with significant human resource issues.

Desirable

• Demonstrable research experience or clinical trials experience at a senior level within the pharmaceutical industry

Skills, Knowledge and Ability

Essential

• Strong organisational skills with proven ability to manage competing demands.
• A strong understanding of the issues around patients and public involvement in research.
• Able to deal effectively with difficult situations with staff and patients, skilled in conflict resolution.
• Experience of developing and delivering a training programme for a wide range of staff.
• Ability to analyse complex situations and produce strategic and tactical approaches to resolution.
• Able to collaborate constructively with internal and external partners to create the conditions for successful partnership working.
• Ability to work under pressure and manage/deliver within deadlines.

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.

Certificate of Sponsorship

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).

Employer details

Employer name

Guy's and St Thomas' NHS Foundation Trust

Address

Guys Hospital

Great Maze Pond

London

SE1 9RT

Employer's website

https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)