Overview
The Cancer Clinical Trials Unit at UCLH is recruiting a Data Manager to support a portfolio of Phase I–III clinical trials in the Gastrointestinal trials team. You may be required to cover other disease areas on a short-term or longer-term basis.
The post-holder will deliver and verify trial-specific information to sponsors, support 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 a supportive and dynamic team, working closely with clinical research staff. The role is administrative but vital to 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.
Responsibilities
* 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 to a 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.
* Prioritise 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 upcoming, 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 samples and upload scans as required by trial protocol.
* Escalate issues to senior team members.
* Operate within a diverse portfolio reflecting the varied nature of the disease area; work autonomously while collaborating with the trials team and doctors.
Qualifications and Experience
Knowledge and Qualifications
* Essential: Life Science degree.
* Essential: Knowledge of the concept of clinical trials.
* Essential: Knowledge of ICH GCP.
* Desirable: Knowledge of oncology and/or haematology.
Experience
* Essential: Experience of working under minimal supervision.
* Essential: Experience of working to deadlines.
* Desirable: Experience of independently carrying out a research project.
* Desirable: Experience of working in a healthcare setting.
* Desirable: Experience of conducting clinical trials.
Skills and Abilities
* Essential: Proven ability to work under own initiative.
* Essential: Knowledge of ICH GCP.
* Essential: Computer literacy to include Word and Excel.
* Desirable: Knowledge of oncology and/or haematology.
Communication
* Essential: Proven ability to communicate effectively in writing.
Personal and People Development
* Essential: Good eye for detail.
* Essential: Enthusiastic disposition.
* Essential: Ability to identify own training needs.
* Essential: Desire for professional and personal development.
Other Information
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and a Disclosure to the Disclosure and Barring Service will be required to check for any previous criminal convictions. Applications from job seekers requiring Skilled Worker sponsorship to work in the UK will be considered alongside all other applications.
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