Clinical Trials Manager - Research & Development

East And North Hertfordshire Teaching Nhs Trust; Tankerton; On-site; GBP 42,000 - 54,000; Full time

Benefits offered by this job

High Cost Area Supplement

Job summary

East and North Hertfordshire NHS Trust is seeking a Clinical Trials Manager to support the Oncology Research Team at MVCC. The role focuses on trial administration from feasibility to archiving in line with GCP and SOPs, with emphasis on audit readiness and effective data management.

The post entails workforce planning, reporting on recruitment, and close collaboration with the Head of Research and Governance Lead to prepare for audits. Commitment to equality and flexible working is encouraged.

Qualifications

• Experience in clinical trial administration including data management.
• Experience in staff supervision/management.
• Knowledge of GCP, SOPs and trust policies.

Responsibilities

• Support clinical research team with all aspects of trial administration from feasibility to archiving.
• Ensure efficient and timely set up of clinical trials.
• Maintain databases/spreadsheets and produce monthly recruitment reports.
• Workforce planning to manage trial activity and form completion.

Skills

Multidisciplinary teamwork

Prioritise workload

Communication skills

Audit/quality understanding

Written and verbal communication

Education

Postgraduate research qualification

Tools

Study management software

Microsoft Office

Job description

Job summary

We are recruiting for a Clinical Trials Manager who shares our vision to be trusted to provide consistently outstanding care and exemplary service to our patients. We are looking for an enthusiastic and energetic individual with a clear understanding of issues relating to management of clinical research in the NHS to join our Clinical Oncology Research Team at Mount Vernon Cancer Centre. The Trust is a member of the National Institute for Health Research, fully supports the Health Research Authority and is committed to fully implementing the UK policy framework for health and social care research. Previous experience would be highly desirable. At the heart of everything we do are our core values: Include, Respect, and Improve. We encourage you to embrace these values throughout the recruitment process and in your role with us.

Main duties of the job

The main purpose of the role is to support the clinical research team with all aspects of clinical trials administration, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and trust policies. The post holder will provide support to the Research Nurses and wider Clinical Research Team and undertake Management of Band 5 Snr Clinical Trial Coordinator(s). The post holder will be responsible for the administration of clinical trials from feasibility to archiving including (but not limited to):

• Responsible for the efficient and timely set up of clinical trials.
• Responsible for maintaining databases/spreadsheets and production of monthly progress reports on recruitment.
• Workforce planning to manage trial activity ensuring case report form completion and amendment processing meets internal and external deadlines.
• Oversee quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
• Working closely with the Head of Research and Research Governance Lead to ensure preparation for audit and inspections within assigned teams.

About us

At East and North Hertfordshire NHS Trust, we are proud of the range of general & specialist services we provide & our 6,000 or so dedicated staff ensure our patients get the best care. Our ability to be flexible & innovative in the way in which we work and deliver our services to our catchment has never been more important than it is now.

We run the following hospitals:

• The Lister Hospital, Stevenage
• New Queen Elizabeth II (New QEII), Welwyn Garden City
• Hertford County, Hertford
• Mount Vernon Cancer Centre (MVCC), Northwood

We have ambitious plans to become an outstanding, patient-led Trust where dedicated staff provide high-quality, compassionate care to our patients. We continue to undergo significant transformation; our staff & patients are at the heart of delivering this ambitious agenda.

We understand that finding and starting a new job is an important life decision. If you need reasonable adjustments for a disability, or a life event, such as menopause - so that we can consider your application fairly & to get the best out of you during the selection process, please let us know.

We are committed to a positive work life balance for our employees. Employees are entitled to seek to work flexible working patterns & we are committed to listen and consider all requests. Such requests, of course, have to be made & considered formally, & will need to be balanced against service needs, but our starting point will always be to find ways to support making them happen.

Job responsibilities

In addition, you will receive a High Cost Area Supplement of 15% of your basic salary, subject to a minimum payment of £4,314 and a maximum payment of £5,436 per annum pro rata. Please see the attached Job Description and Person Specification applicant pack for further detailed information regarding this role.

Person Specification

Skills

Essential

• Proven effectiveness as working as part of a multidisciplinary team
• Demonstrates ability to prioritise workload
• Demonstrates ability to work under own initiative
• Demonstrates evidence of professional development
• Demonstrates understanding of the importance of audit/quality
• Proven ability to communicate effectively in writing and verbally
• Proven ability to work effectively under pressure
• Computer literacy

Previous Experience

Essential

• Significant experience in clinical trial administration including data management.
• Experience of staff supervision/ Management
• Experience of working in a healthcare setting
• Experience in Study Set up, Feasibility and Contracts Management

Qualifications/Training

Essential

• Post graduate level qualification/courses or equivalent experience within research and /or a related field
• Willingness to undertake training as appropriate for role

Desirable

• Relevant training courses in clinical research

Knowledge

Essential

• Detailed knowledge of the clinical trials process and GCP guidelines/EU directives
• Knowledge of case reports forms.
• Understanding of medical terminology.
• Knowledge of patient information systems.

Other Requirements

Essential

• Experience and evidence of engagement around equality, diversity and inclusion issues in relation to policy, service development and service delivery in respect of both services to users and the management of staff
• Role model our Trust values every day

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.

We are committed to equal opportunities and welcome applications from all sections of the community.