Royal Papworth Hospital NHS Foundation Trust
This is an exciting opportunity for an experienced Operations Manager to join and lead the Clinical Research Facility based in the Victor Philip Dadaleh Heart & Lung Research Institute (VPD-HLRI). The CRF is a collaboration between Royal Papworth Hospital and the University of Cambridge.
The role will provide strategic and operational leadership to the Clinical Research Facility which supports a portfolio of early phase cardiorespiratory studies. Previous experience in a Clinical Research Facility or equivalent research environment is essential as well as significant operational experience in managing complex, high intensity, early phase experimental medicine research including first in human studies.
The CRF management team comprises of a Clinical Director, the Operations Manager and a Nurse Team Leader, who lead a talented multi-disciplinary team to deliver a portfolio of innovative high quality research studies.
Main duties of the job
The post holder will be responsible for the operational leadership, governance, management, strategic planning and development of the Victor Philip Dadaleh Heart & Lung Research Institute (VPD-HLRI) Clinical Research Facility and will provide research leadership to staff working in the Facility and users of the facility.
The post holder will have responsibility for managing all clinical research studies conducted within the area of responsibility, ensuring that studies are run to the highest standards incorporating Good Clinical Practice Guidelines.
The post-holder will be responsible for writing annual and other ad hoc reports, collecting study and activity metrics in accordance with NIHR Clinical Research Facility award contract to Director of Operations, NIHR Cambridge Clinical Research Facility.
As a member of the senior team in RPH R&D, the CRF Manager will contribute to the delivery of the Trust research agenda working in partnership with senior CRF & R&D nursing leadership where required to ensure research is conducted to time and target.
The post-holder will be responsible for the CRF Facility within the HLRI: maintenance, equipment and facilities staff and will coordinate and manage new facilities projects.
Person Specification
Qualifications
* Degree in clinical or life sciences related subject, supplemented by relevant specialist training and or experience to masters level equivalent.
* Evidence of continuous professional development.
* Previous experience in a Clinical Research Facility or equivalent research environment.
* Masters or working towards Leadership or Management training/module.
Experience
* Significant operational experience in managing complex, high intensity, early phase experimental medicine research including first in human.
* Extensive experience in budget / grant management.
* Proven Negotiation and facilitation skills.
* Experience of change management & teaching.
* Practical experience of policy development.
* Advanced working knowledge of Research governance / clinical governance / Research regulatory requirements / ICH GCP including familiarity with issues surrounding clinical data, particularly confidentiality.
* Innovative, able to problem solve and make decisions.
* Understanding of clinical trial processes and legal requirements including familiarity with issues surrounding clinical data, particularly confidentiality.
* Knowledge and understanding of NHS R&D systems, processes and legislation, including the HTA.
* Well-developed interpersonal and communication skills to work with clinical and management colleagues at all levels.
* Organisation and time management skills to manage and deliver a range of tasks and projects to tight deadlines.
* Highly motivated with the ability to influence and inspire others.
* Proven team leadership and team leading skills.
* Ability to work autonomously: able to plan, prioritise + co-ordinate work under pressure.
* Clinical management of multiple complex studies & teams.
* Able to work collaboratively as part of a multidisciplinary team across a broad range of clinical specialties.
* Highly motivated and effective communicator with proven ability to influence all levels of staff.
* Skills in preparing and delivering reports.
* Flexible approach to working, including ability to problem solve and provide advice, guidance and support to others.
* Senior managerial experience within a CRF.
* Experience of preparing and co-ordinating external audits and MHRA GCP Inspections.
* Experience of working within an MHRA Phase 1 accredited unit.
* Experience of Public involvement and engagement.
* Awareness of campus wide research infrastructure and developments.
* Awareness of UK Clinical Research Agenda, current National and Trust Nursing initiatives.
Additional Criteria
* Please provide evidence of your commitment to uphold the Trust's values: Compassion, Excellence, Collaboration.
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.
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