Clinical Trial Data Manager

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Job overview

The Cancer Clinical Trials Unit at UCLH is looking to recruit a Data Manager to support a portfolio of Phase I-III clinical trials in the Genitourinary/Head and Neck Team. You may be required to cover other disease areas on a short-term or longer-term basis.

The post-holder will be required to deliver and verify trial-specific information to sponsors, support the team with the set-up of new clinical trials and assist as needed with the processing of biological samples, amongst other tasks. You will be part of supportive and dynamic team, working closely with clinical research staff. Whilst the position is administrative, the role is vital in supporting clinical research staff deliver excellent care to patients with cancer.

We are currently supporting hybrid remote working, allowing a combination of working from home and office-based working. Flexibility around on-site working is essential, and you may be required to attend the office at relatively short notice to ensure that the service is covered.

We ideally want someone with experience of clinical research, knowledge of cancer, good verbal and written communication skills and some experience of working in a healthcare setting.

However, if you have some of these criteria and clear enthusiasm for the role, then please apply.

Main duties of the job

The post holder will:

• Have a portfolio of trials for which they are responsible
• Complete data entry into case report forms for assigned trials as per protocols
• Ensure case report forms are completed are of high quality, accurate and sent in a timely manner
• Resolve issues with source data and anomalous data at the time of reporting, reviewing against previously reported data as well as local and national normal ranges.
• Prioritises workload to manage time effectively
• Process updated information and documents for the successful running of the study
• Create and maintain both paper and electronic trial site files
• Maintain list/database of up-coming, current and recently closed clinical trials
• Maintain electronic and paper list of accrual to trials
• Organise and prepare documentation for audits and monitoring visits.
• Process biological samples in the trials lab
• Liaise with the MDT, Principal and Sub Investigators, Sponsors, and support departments professionally and appropriately
• Obtain tumour block sample
• Upload scans as required by trial protocol
• Escalate issues to senior team members

The portfolio is very diverse, with a wide range of studies, to reflect the varied nature of the disease area in this age group. The successful applicant should be organised, pro-active and able to work autonomously, while also collaborating and communicating with the rest of the trials team and the doctor. Full duties are explained in the attached job description.

Working for our organisation

University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. We provide academically led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas. Our vision is to deliver top-quality patient care, excellent education, and world-class research.

We provide first-class acute and specialist services across eight sites:

• University College Hospital (incorporating the Elizabeth Garrett Anderson Wing)

• National Hospital for Neurology and Neurosurgery

• Royal National ENT and Eastman Dental Hospitals

• University College Hospital Grafton Way Building

• Royal London Hospital for Integrated Medicine

• University College Hospital Macmillan Cancer Centre

• The Hospital for Tropical Diseases

• University College Hospital at Westmoreland Street

We are dedicated to the diagnosis and treatment of many complex illnesses. UCLH specialises in women's health and the treatment of cancer, infection, neurological, gastrointestinal and oral disease. It has world class support services including critical care, imaging, nuclear medicine and pathology.

We are committed to sustainability and have pledged to become a carbon net zero health service, embedding sustainable practice throughout UCLH. We have set an ambitious target of net zero for our direct emissions by 2031 and indirect emissions by 2040.

Detailed job description and main responsibilities

For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.

The Cancer Clinical Trials Unit office is based in 250 Euston Rd and comprises of three main areas: Haematology, Oncology and Complex Pathways and it supports activity in the local Clinical Research Facility and the North Thames Local Comprehensive Research Network and Experimental Cancer Centre.

Each group is comprised of teams of research nurses, clinical trial practitioners and data managers and provides support to local Investigators wishing to conduct clinical trials and other high quality clinical research projects within UCLH.

Each team supports a process for agreeing a portfolio of research and ensures that trials are conducted to the highest standards and in accordance with UK legislation and the R&D Governance Framework. The aim of the Unit is to effectively use resources so as to ensure that patients have access to entry into clinical trials, as appropriate, and maintain the highest quality of care for patients.

Cancer Services sits within the Surgery and Cancer Board. It incorporates comprehensive outpatient, day care, and ambulatory care and inpatient services for the specialities of inpatient and outpatient oncology and Haematology.

Come and be a part of the best NHS trust in England to work for, according to our staff*

UCLH top trust to work at in England - for the second year running! : University College London Hospitals NHS Foundation Trust

*In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England - for the second year in a row.

UCLH top trust to work at in England - for the second year running! University College London Hospitals NHS Foundation Trust.

Once again, UCLH has received the highest score of all general acute and acute/community NHS trusts in England for staff that would recommend us as a place to work.

Person specification

Knowledge and Qualifications

Essential criteria

• Life Science degree
• Knowledge of drug development process and concept of clinical trials
• ledge of ICH GCP

Desirable criteria

• Knowledge of oncology and/or haematology

Experience

Essential criteria

• Experience of working under minimal supervision
• Experience of working as part of large teams
• Experience of working to deadlines
• Experience of independently carrying out a research project
• Experience of conducting clinical trials

Skills and Abilities

Essential criteria

• Proven ability to work under own initiative.
• Computer literacy to include experience of Word & Excel

Desirable criteria

• Knowledge of ICH GCP
• Knowledge of oncology and/or haematology

Communication

Essential criteria

• Proven ability to communicate effectively in writing.

Personal and People Development

Essential criteria

• Good eye for detail
• Ability to identify own training needs
• Displays desire for professional and personal development

At UCLH, we have a real 'One Team' ethos, and our values - safety, kindness, teamwork and improving, are central to the way we work. This is supported by our staff, who voted us as the #1 NHS Acute Trust to work for in the whole of England.

At UCLH we take equality of opportunity seriously and are committed to being a diverse and inclusive employer, with a culture that creates a real sense of belonging and trust. It is our fundamental aim, to recruit, retain and promote a diverse mix of people who are representative of our local communities. Applications are encouraged from candidates of all backgrounds, cultures, and perspectives to support our world class research, innovation and creativity.

UCLH recognises the benefits of flexible working for staff and has a dedicated policy which allows staff to apply for flexible working right from the beginning of employment. For more information please go to: https://www.uclh.nhs.uk/work-with-us/why-choose-uclh/flexible-working.

We offer our permanent staff an interest free season ticket loan for travel, all our staff have access to free independent and confidential support, large retail discounts, a staff discount platform, cycle to work scheme and on-site accommodation to name a few.

Additionally, UCLH Arts and Heritage's staff wellbeing programme, Creative Comfort, offers a variety of ways to engage with the arts as a member of UCLH staff. You can try out the weekly choir, weekly art club and join the Culture Club for exclusive access to free and discounted tickets for opera, exhibitions, theatre and more.

We recognise, reward and thank colleagues by nominating them for our annual Celebrating Excellence Awards, which are funded by UCLH Charity.

We are also members of www.mytrustbenefits.co.uk/ which offers discounts on high street retail stores, offers on travel deals, and also to take advantage of cash back schemes.

This vacancy may close before the current listed closing date. You are advised not to delay submitting your completed application.

Please note that all correspondence regarding your application will be via email. The emails will be sent to you via TRAC.jobs and not via NHS Jobs, we encourage you to check your inbox regularly.

Please note that if you are at present in a training position on the 2016 new junior doctor's contract and are applying for a Trust doctor role your salary will not be pay protected.

You will be placed on the appropriate point of the Trust Doctor pay scale based on your previous experience.

Please note that if you have not heard from us within 3 weeks of the closing date of the advert to assume that you have not been shortlisted on this occasion.

The Trust uses electronic new starter forms on Trac to collect personal details. Information collected is securely stored and used to set up the employee record on the ESR HR system.

Employer certification / accreditation badges

Documents to download

• Job Description (PDF, 329.2KB)
• Functional Requirement (PDF, 262.3KB)
• UCLH Values (PDF, 860.9KB)