B6 Trials Manager

Liverpool Heart and Chest Hospital

Information:

This job is now closed

Job summary

Liverpool heart and Chest Hospital (LHCH) has collaborated with Liverpool University Hospitals Foundation Trust (LUFHT) and Clatterbridge Cancer Centre (CCC) to develop the new NIHR Liverpool CRF (Clinical Research Facility). This new collaboration is an exciting opportunity for both staff and patients, as we will see an increase in early phase and translational research across the Liverpool region. LHCH is leading on the cardiac theme. This is a recently established post and it is a really exciting time to be joining the expanding research team at LHCH.

LUFHT CRU (Clinical Research Unit) is an accredited Phase 1 unit and therefore access to specalised training and supervision will be jointly provided by LHCH and LUHFT. The post is located at LHCH and the post holder will be expected to set up clinical trials that are associated with the CRF at LHCH and ensure that the patients are cared for and looked after throughout their research journey. There will be some requirements to attend LUFHT for training, supervision and to support set up and delivery of studies, on a needs basis.

Main duties of the job

The post holder will co-ordinate Early Phase CRU led Clinical trials under leadership direction of the Principal Investigator and the senior leadership team. Responsibilities typically include contributing to the development and management of the protocol, budget, timeline, quality guidelines and being the primary point of contact for the Sponsor, thereby ensuring that expectations are met while identifying and mitigating risks. The Project Manager also compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data including Ethics Submissions.

About us

As the largest single site specialist heart and chest hospital in the UK, we, at Liverpool Heart and Chest Hospital, have a clear vision 'to be the best cardiothoracic integrated healthcare organisation'.

We provide specialist services in cardiothoracic surgery, cardiology, respiratory medicine both in the hospital and out in the community.

We serve a catchment area of 2.8 million people, spanning Merseyside, Cheshire, North Wales and the Isle of Man, and increasingly we receive referrals from outside these areas for highly specialised services such as aortics.

Our reputation for strong performance is important in delivering the best care for our patients and high quality clinical services. This is underpinned by a culture of research and innovation, delivered in modern estate and our encouragement of flexible working in a variety of forms.

Please visit our website - https://www.lhch.nhs.uk/

Please follow this link for a tour of our site - https://bit.ly/36ylsoq

Date posted

29 January 2024

Pay scheme

Agenda for change

Band

Band 6

Salary

£35,392 to £42,618 a year

Contract

Permanent

Working pattern

Full-time, Flexible working

Reference number

C9410-24-0028

Job locations

Liverpool Heart and Chest Hospital

Thomas Drive

Liverpool

Merseyside

L14 3PE


Job description

Job responsibilities

PRINCIPAL ACCOUNTABILITIES

Manage and track project resource needs and contribute to contingency planning for key resources.

Create required project plans utilising appropriate planning software. Implement and monitor progress against project plans and revise as necessary.

Monitor trial/project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations.

Oversee/complete accurate and timely Ethics/R&D Submissions in conjunction with the Lead Nurse

Serve as client/sponsor/internal stakeholders primary contact for assigned studies.

Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects.

Meet/exceed client/sponsor satisfaction expectations.

Present at external and/or internal meetings, with support from a more senior manager or Principal Investigator as needed.

Assist in ensuring that all staff allocated to assigned projects adhere to professional, SOP, and specific GCP and ICH standards.

Review proposals and budgets.

Follow defined project issue escalation process

With support from more senior management positions and the Principal Investigator, monitor and control the risk plan and provide on-going oversight to ensure mitigation plans are in place and working. Escalate risks newly identified by the project team to stakeholders.

With support from more senior management positions, meet financial performance targets for the assigned projects and proactively identify out of scope activities and execute necessary work scope change orders.

Ensure that site monitoring reports and monitoring visits are completed in a timely manner. Review monitoring reports and escalate issues.

Establish working relationships with clients/sponsors which result in client satisfaction, operational excellence and thereby increase potential for repeat business.

Contribute and participate in the delivery of presentations for new business, as required.

Ensure that internal project review meetings are conducted as needed. Depending on size and scope of project, lead meetings as appropriate.

Perform other duties as assigned by management.

Development of Case Report Forms and set up of databases for the delivery of CRF studies such as REDCap.

CLINICAL GOVERNANCE/ QUALITY

To work closely with the CRU team to deliver high quality research governance regulations including ICH-GCP.

To assist the research teams including CRU/CRF and R&I with quality control and quality assurance and audit processes.

Compliance with Trust, Directorate and R&D SOPs, policies and protocols.

Maintenance of personal and professional development.

MANAGERIAL/LEADERSHIP

To work on the development of databases and electronic trial management systems to provide effective oversight of research delivery.

Ensure clear escalation processes and guidance is followed in reporting of all adverse events.

Exercise strong and effective leadership acting as an exemplary role model for the CRF team.

Ensure compliance with mandatory training and maintain current records.

Responsible for the implementation of risk management policies, including the development, implementation and monitoring of action plans to address identified risks.

To have a comprehensive knowledge of clinical research including issues on ethics, legislation management in clinical research.

Authorised signatory for department purchases through SBS.

ORGANISATIONAL

Ensure appropriate allocation of study time for professional development and staff compliance with Trusts study leave policy.

Provide escalation reports and study reports to the appropriate committees for review.

Attend appropriate team and departmental meetings as required such as the R&I Committee.

Job description

Job responsibilities

PRINCIPAL ACCOUNTABILITIES

Manage and track project resource needs and contribute to contingency planning for key resources.

Create required project plans utilising appropriate planning software. Implement and monitor progress against project plans and revise as necessary.

Monitor trial/project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations.

Oversee/complete accurate and timely Ethics/R&D Submissions in conjunction with the Lead Nurse

Serve as client/sponsor/internal stakeholders primary contact for assigned studies.

Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects.

Meet/exceed client/sponsor satisfaction expectations.

Present at external and/or internal meetings, with support from a more senior manager or Principal Investigator as needed.

Assist in ensuring that all staff allocated to assigned projects adhere to professional, SOP, and specific GCP and ICH standards.

Review proposals and budgets.

Follow defined project issue escalation process

With support from more senior management positions and the Principal Investigator, monitor and control the risk plan and provide on-going oversight to ensure mitigation plans are in place and working. Escalate risks newly identified by the project team to stakeholders.

With support from more senior management positions, meet financial performance targets for the assigned projects and proactively identify out of scope activities and execute necessary work scope change orders.

Ensure that site monitoring reports and monitoring visits are completed in a timely manner. Review monitoring reports and escalate issues.

Establish working relationships with clients/sponsors which result in client satisfaction, operational excellence and thereby increase potential for repeat business.

Contribute and participate in the delivery of presentations for new business, as required.

Ensure that internal project review meetings are conducted as needed. Depending on size and scope of project, lead meetings as appropriate.

Perform other duties as assigned by management.

Development of Case Report Forms and set up of databases for the delivery of CRF studies such as REDCap.

CLINICAL GOVERNANCE/ QUALITY

To work closely with the CRU team to deliver high quality research governance regulations including ICH-GCP.

To assist the research teams including CRU/CRF and R&I with quality control and quality assurance and audit processes.

Compliance with Trust, Directorate and R&D SOPs, policies and protocols.

Maintenance of personal and professional development.

MANAGERIAL/LEADERSHIP

To work on the development of databases and electronic trial management systems to provide effective oversight of research delivery.

Ensure clear escalation processes and guidance is followed in reporting of all adverse events.

Exercise strong and effective leadership acting as an exemplary role model for the CRF team.

Ensure compliance with mandatory training and maintain current records.

Responsible for the implementation of risk management policies, including the development, implementation and monitoring of action plans to address identified risks.

To have a comprehensive knowledge of clinical research including issues on ethics, legislation management in clinical research.

Authorised signatory for department purchases through SBS.

ORGANISATIONAL

Ensure appropriate allocation of study time for professional development and staff compliance with Trusts study leave policy.

Provide escalation reports and study reports to the appropriate committees for review.

Attend appropriate team and departmental meetings as required such as the R&I Committee.

Person Specification

Qualifications

Essential

  • Graduate with Hons Degree, preferably in a science or clinical area.

Desirable

  • Relevant clinical research experience in a pharmaceutical company/CRO including study management and/or project management experience.

Values and Behaviours

Essential

  • Meticulous attention to detail and a high standard of accuracy.
  • Flexible approach to working hours.
  • Good communication skills and ability to articulate complex information
  • Work well as part of a team and able to motivate and support others.

Experience

Essential

  • Experience in managing or co-ordination of clinical studies.
  • Experience in effective use of Microsoft Office package including Microsoft Project or other planning software.
  • Knowledge of the principles & practice of clinical research and/or clinical trials.
  • Knowledge of ethical and quality standards applicable to clinical trials, including EU Directive ICH/GCP requirements.
  • Demonstrate knowledge of NHS Research Governance.
  • Understanding of the drug development process.
  • Ability to understand and work with financial information.
  • Working knowledge of project management processes.

Desirable

  • Experience of liaison with staff at all levels in the NHS, Universities and Industry.
  • Leadership/management experience.
  • Experience of being a client/sponsors primary point of contact.
  • Experience in Phase I Clinical Trials.

Skills and Abilities

Essential

  • Good communication, presentational, training and interpersonal skills.
  • Ability to use a personal computer.
  • Skills in administration & project management.
  • Ability to meet tight deadlines and cope in a highly demanding environment.
  • Ability to work independently and prioritise/own workload and to communicate effectively with all members of the multi-disciplinary team.
  • Ability to liaise with clients/sponsors in a professional manner.
  • Good planning and organisation skills.

Desirable

  • Skills in handling and management of computerised data.
  • Skills in developing Case Report Forms.
  • Skills in developing databases.
  • Skills in handling and management of computerised data.
  • Skills in the analysis and interpretation of data.
Person Specification

Qualifications

Essential

  • Graduate with Hons Degree, preferably in a science or clinical area.

Desirable

  • Relevant clinical research experience in a pharmaceutical company/CRO including study management and/or project management experience.

Values and Behaviours

Essential

  • Meticulous attention to detail and a high standard of accuracy.
  • Flexible approach to working hours.
  • Good communication skills and ability to articulate complex information
  • Work well as part of a team and able to motivate and support others.

Experience

Essential

  • Experience in managing or co-ordination of clinical studies.
  • Experience in effective use of Microsoft Office package including Microsoft Project or other planning software.
  • Knowledge of the principles & practice of clinical research and/or clinical trials.
  • Knowledge of ethical and quality standards applicable to clinical trials, including EU Directive ICH/GCP requirements.
  • Demonstrate knowledge of NHS Research Governance.
  • Understanding of the drug development process.
  • Ability to understand and work with financial information.
  • Working knowledge of project management processes.

Desirable

  • Experience of liaison with staff at all levels in the NHS, Universities and Industry.
  • Leadership/management experience.
  • Experience of being a client/sponsors primary point of contact.
  • Experience in Phase I Clinical Trials.

Skills and Abilities

Essential

  • Good communication, presentational, training and interpersonal skills.
  • Ability to use a personal computer.
  • Skills in administration & project management.
  • Ability to meet tight deadlines and cope in a highly demanding environment.
  • Ability to work independently and prioritise/own workload and to communicate effectively with all members of the multi-disciplinary team.
  • Ability to liaise with clients/sponsors in a professional manner.
  • Good planning and organisation skills.

Desirable

  • Skills in handling and management of computerised data.
  • Skills in developing Case Report Forms.
  • Skills in developing databases.
  • Skills in handling and management of computerised data.
  • Skills in the analysis and interpretation of data.

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.

Employer details

Employer name

Liverpool Heart and Chest Hospital

Address

Liverpool Heart and Chest Hospital

Thomas Drive

Liverpool

Merseyside

L14 3PE


Employer's website

https://www.lhch.nhs.uk/ (Opens in a new tab)

Employer details

Employer name

Liverpool Heart and Chest Hospital

Address

Liverpool Heart and Chest Hospital

Thomas Drive

Liverpool

Merseyside

L14 3PE


Employer's website

https://www.lhch.nhs.uk/ (Opens in a new tab)

For questions about the job, contact:

Head of Research Governance

Martika Taylor

martika.taylor@lhch.nhs.uk

01512543036

Date posted

29 January 2024

Pay scheme

Agenda for change

Band

Band 6

Salary

£35,392 to £42,618 a year

Contract

Permanent

Working pattern

Full-time, Flexible working

Reference number

C9410-24-0028

Job locations

Liverpool Heart and Chest Hospital

Thomas Drive

Liverpool

Merseyside

L14 3PE


Supporting documents

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