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Commercial Research Manager (XN07)

Employer
Leeds Teaching Hospitals NHS Trust
Location
Leeds
Salary
£43,742 to £50,056 a year
Closing date
24 Dec 2023

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Are you a dynamic and experienced professional with a passion for driving delivery in research? Do you thrive in collaborative environments and possess exceptional communication skills? If so, we invite you to join our team as a Commercial Research Manager.

This post will also be considered as a job share or supported under a secondment agreement. The post is fixed term until 30th September 2023 with potential for extension.

Main duties of the job

The Commercial Research Manager will play a pivotal role in ensuring the successful delivery of commercial research trials across the CRN Yorkshire and Humber Clinical Research Network.

You will monitor the performance of the commercial research portfolio, in line with national High-Level Objectives (HLOs), and work closely with the regional research teams and commercial sponsors to identify where and how CRN support can make a positive difference.

You must be flexible, able to handle pressure well and possess a high level of communication, organisation, analytical and technical skills.

You will have good IT knowledge of online meeting software, Word and Excel and administrative experience, preferably in a healthcare, research or event management.

You need to be able to use your own initiative, have good attention to detail and work well within a team.

About us

The National Institute for Health Research Clinical Research Network (NIHR CRN) has been created as part of the Department of Healths R& D strategy, to provide a world-class infrastructure for clinical trials and high-quality research in all areas of disease and clinical need within the NHS. The Clinical Research Network Yorkshire and Humber is one of 15 Local Clinical Research Networks (LCRNs) in England and aims to support clinical and R& D teams to recruit NHS patients to NIHR portfolio studies.

The CRN Y& H includes 22 Trusts and 4 Integrated Care Boards and provides a coordinated and efficient infrastructure of research personnel and facilities to support recruitment and drive clinical research delivery performance across the locality.

Leeds Teaching Hospitals is committed to our process of redeploying 'at risk' members of our existing workforce to new roles. As such, all our job adverts are subject to this policy and we reserve the right to close, delay or remove adverts while this process is completed. If you do experience a delay in the shortlisting stage of the recruitment cycle, please bear with us while this process is completed, and contact the named contact if you have any questions.

Job description

Job responsibilities

JOB PURPOSE/SUMMARY

The post holder will be a key member of the CRN Y& H Industry Team, providing support to aid swift set-up times and recruitment for all commercial portfolio studies. Working as part of the Industry Team, the post holder will work collaboratively with internal teams, CRN Coordinating Centres and external organisations involved in the running of research across Yorkshire and Humber. They will have experience of working within a clinical research environment & will have knowledge of the research regulatory processes for gaining HRA and Trust approvals for gaining NHS permission (CSP) to ensure effective and efficient study set up.

The post holder will play a key role in locally supporting the network's feasibility process, helping determine where to place commercial studies & carry out feasibility with teams. Active performance management of studies is also a key aspect of the role. As such the post holder must have a full understanding of the aims and objectives of the NIHR CRN.

The post holder will assist with training other team members, be expected to deliver presentations to researchers and stakeholders and will actively promote the aims, objectives and work of the industry team/ CRN: Y& H.

The Post holder will be expected to participate fully in their personal development and review processes in order to achieve the knowledge, skills and objectives identified for this post. Although based at LTHT, the post holder will be required travel across Yorkshire and Humber to work with clinical investigators, research staff and sponsor companies/ CROs to facilitate the delivery of the commercial portfolio.

PRINCIPAL DUTIES & AREAS OF RESPONSIBILITY

Research:

Work collaboratively as a member of the Industry team providing support across a number of research projects covering a variety of disciplines.

Actively facilitate the CRN feasibility and site selection processes. Working with research sites, CROs/Sponsors, CRN Coordinating Centre to ensure timely set up of clinical trials.

Actively support sites with the completion of network feasibility forms, providing training as needed.

Work with other members of the industry team, sponsors/CROs, Speciality leads to develop and promote new research sites.

Support the Industry admin team and other facilitators in the daily management of the industry email inbox.

Have excellent communication skills, being responsible for developing and maintaining positive and strong interdepartmental and cross-organisational relationships effectively.

Liaising with the Life Sciences Industry to ensure barriers to timely study site set up, with particular respect to costing and contract negotiation.

Have specialist knowledge of research specific guidelines e.g. Good Clinical Practice (GCP), Research Governance and EU Clinical Trials Directives.

Have knowledge of the research regulatory processes for gaining Health research Authority to ensure effective and efficient study set up.

Attend and contribute to National CRN Industry meetings as required.

Keep up to date with national research issues/changes relating to commercial research and seek to understand their implications for CRN Y& H.

Support the use and development of the CRN: Y& H Feasibility Tool.

Represent CRN Y& H industry Team & contribute to relevant local/national working groups as appropriate.

Performance Management:

Attendance at site selection and site initiation visits. Working with sites and sponsors/CROs to troubleshoot set up issues and develop recruitment strategies. Resolving/escalating issues as appropriate.

Identify early blocks in performance and develop strategies to deal with these in conjunction with sites, R& D Depts, Industry sponsor/CRO, and CRN Coordinating centres.

Work in partnership with the Industry Operations Manager and Research Delivery Managers to design and implement appropriate risk management processes including contingency planning, project plans, risk analysis and innovative strategies to increase recruitment ensuring delivery to time and target of the commercial contract portfolio.

Analyse, interpret and resolve highly complex problems where they may not be precedence and where opinions conflict

Collaborate with stakeholders to pinpoint opportunities for utilising funding streams to overcome barriers and facilitate support through targeted funding proposals.

Work with sites to monitor on-going accurate accrual data, recording on the Local Portfolio Management System (LPMS) and Central Portfolio Management System (CPMS) as required.

Meet with sites to discuss study performance regularly/as required, making use of performance management tools local industry database, Industry RAG report, Open Data Platform.

Working with the Industry Operations Manager/ Industry Team/ Speciality Leads/RDMs to build a working knowledge of the PIs and teams across Y& H, supporting new PIs & teams as required.

Arrange regular Performance Management Meetings with RDMs to discuss studies as appropriate, making use of performance management tools and reports.

Contribute to/arrange teleconferences with sponsors/CROs/CRN Co-ordinating Centre to discuss studies as appropriate.

Promote and collaborate to develop good working relationships, maintaining good communication pathways with internal and external departments.

Identify where relevant funding streams/budgets

Leadership and Management:

Act as a support for the Senior Management Team and in particular the Industry Operations Manager as well as other member of the industry team

To prepare/contribute to the annual report on current research activity, illustrating the achievements and future goals of the team.

Assist Industry Operations Manager/ Chief Operating Officer/RDMs in the development of business plans as appropriate.

Develop and maintain Leadership and organisational skills relevant to the post.

Assist in the recruitment, support and orientation of new staff as required.

Develop and maintain organisational and project managerial skills relevant to the role.

Assist with the day-to-day supervision of junior staff and support on-going staff development. Providing line management duties as required.

Be actively involved in promoting the research work of the Network.

Actively participate in the CRN Y& H research strategy and objectives, promoting, supporting and delivering the core values of the NIHR.

Act as a professional role model, through commitment, integration and practice of Trust policies and procedures.

Work closely with the key stakeholders to enable the implementation of the CRN Y& H Life Science Strategy across the region.

Attend and contribute to Team meetings and other work related meetings as appropriate.

Safeguard working practices, adhering to health & safety policies. Take responsibility for reporting incidents and performing risk assessments when necessary.

Employ appropriate and effective communication with other team members, inter- departmental staff and external collaborators.

Undertake staff appraisals as required.

Education:

Act as a mentor to junior members of the team, encouraging a high level of motivation in all involved.

Participate in the development and delivery of teaching and education programmes.

Act a resource for investigators, other members of the multi-disciplinary teams from both internal and external agencies.

Present at meetings and conferences as appropriate.

Share knowledge and identify training needs of junior members of the team.

Professional:

Participate positively in regular 1-2-1 supervision and annual appraisal processes.

Maintain an updated professional profile, including updating your own knowledge and educational achievements.

Other:

Flexibility

Post holder is expected to be able to work flexibly, as the service needs dictate. This may be subject to change over time.

Car Driver

Essentially, travel is required, primarily within the CRN Y& H boundaries and occasionally, travel may be essential further afield. Therefore, the post holder must be a car driver and be able to provide their own transport.

Health and Safety

The Trust has a statutory responsibility to provide and maintain a healthy and safe environment for its staff to work in. You equally have a responsibility to ensure that you do nothing to jeopardize the health and safety to either yourself or of anybody else. The Trusts Health and Safety Policies outline your responsibilities regarding Health & Safety at Work.

The post holder must not willingly endanger him/herself or others whilst at work. Safe working practices and safety precautions must be adhered to. Protective clothing and equipment must be used where appropriate.

All accidents/incidents must be reported to your Senior Manager and documented as per Trust Policy, including the reporting of potential hazards.

Infection Control

It is a requirement for all staff to comply with all infection control policies and procedures as set out in the Trust Infection Control Manual.

Security

The post holder has a responsibility to ensure the preservation of NHS property and resources.

Confidentiality

The post holder is required to maintain confidentiality at all times in all aspects of their work.

Team Briefing

The Trust operates a system of Team Briefing, which is based on the principles that people will be more committed to their work if they fully understand the reason behind what is happening in their organisation and how it is performing.

No Smoking Policy

Person Specification

Additional requirements

Essential

  • Understanding of the principles of clinical research
  • Knowledge of NHS research and innovation landscape in the CRN Y& H
  • Understanding of the NIHR Clinical Research Objectives
  • Understanding of the management of clinical research in the NHS and the research regulatory processes for gaining HRA and Trust approvals in line gaining NHS Capability & Capacity
  • Knowledge of the governance standards that apply to clinical research in the NHS, e.g. GCP, Relevant regulatory frameworks, etc
  • Knowledge of maintaining research database
  • Understanding of medical terminology
  • Evidence of ongoing professional development
  • Ability to work flexibly and to travel to all sites across Yorkshire and Humber, as required
  • Car driver and be able to provide own transport.


Experience

Essential

  • Experience of working autonomously and as part of a multi-disciplinary team.
  • Experience in co-ordinating clinical studies from initiation to closure.
  • Experience of line managing staff
  • Ability to organise and prioritise own workload
  • Ability to translate national policy or guidance for application to the local situation
  • Able to collate and compile complex information into written reports.
  • Problem solving/decision making skills
  • Experience of working with industry
  • Experience of working with databases and using reporting tools


Desirable

  • Research Nursing experience.
  • Project Management experience.


Skills & behaviours

Essential

  • Excellent communication skills Good written and analytical skills Good presentation skills
  • Excellent IT skills and demonstrable
  • Proficiency with MS Office applications including Word, PowerPoint and Excel
  • Work well within a team and can also use own initiative


Desirable

  • Evidence of leadership skills
  • Training facilitation skills


Qualifications

Essential


Any attachments will be accessible after you click to apply.

C9298-TEX-0048

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