Clinical Data Manager Ii

Job Summary

This is an excellent opportunity to join a dynamic data management team working as part of the NHSBT Clinical Trials Unit which holds full registration with the UK Clinical Research Collaboration (UKCRC). You will contribute directly to clinical research projects and build good working relationships with NHSBT’s wider research community, contributing to the translation of the basic research into improvements in patient care. The majority of our trials are in the areas of organ donation and transplantation, transfusion medicine and tissues and stem cells, to align with NHSBT’s core business.

You will be an important member of a small but growing team with full responsibility for your allocated trials and will be the primary point of contact. You will also represent Data Management at the monthly Trial Management Group meetings to provide updates to the Trial Managers and Chief Investigators.

There are a variety of trials to work on with new trials in the pipe-line, providing scope for all aspects of Data Management from trial start-up procedures such as database design and build to finalisation procedures and database lock.

Main duties of the job

In this role you will :-

• Act as Clinical Data Manager for one or more trials within the Clinical Trials Unit (CTU) portfolio, with responsibility for data entry and validation
• Design, test and maintain project specific Clinical Databases and case report forms, working as part of the project team
• Extract trial data sets, generating and resolving data queries and providing regular feedback and reports to the Clinical Data Services Manager and the rest of the team
• Tracking the progress of trials with regard to data received, entered and cleaned
• Liaise with the trial Statisiticians to resolve analysis queries
• Act as mentor to the Clinical Data Manager I, to train and supervise as required

About You

Experience and Knowledge

• Highly specialist knowledge of clinical trial databases
• Experience of designing, testing & using databases for clinical research studies
• Experience of website design and maintenance
• Experience of using remote electronic data capture for recording clinical trial data
• Extensive experience in Clinical Data management techniques
• Knowledge of NHS Research Governance ICH – Good Clinical Practice (GCP) guidelines
• Knowledge of UK legislation relating to data protection and freedom of information
• Project management / supervisory experience would be desirable
• Experience of working with Information Technology using Microsoft Office packages (Word, Excel and PowerPoint)

Qualifications and Training

• Honours degree in a relevant science or healthcare subject and/or equivalent body of knowledge related to a scientific/healthcare field OR specialist knowledge gained through working in a Clinical Trial data management setting
• Demonstrates commitment to own continued professional development (CPD)

Please view the attached recruitment profile which is a summary of the detailed Job Description and Person Specification for the full personal attributes we require for the role. You will need to demonstrate these throughout the recruitment process.

About Us

At NHS Blood and Transplant, we’re incredibly proud of the many talented people who come together every day to make our organisation the very best it can be. We have clearly defined values that are centred around offering exceptional care to our donors and their families. We take care of each other too and we focus on building our expertise so we can change lives, provide quality support and offer fulfilling careers.

It’s an opportunity to contribute to a unique team as part of a service that saves lives 365 days a year. We offer brilliant benefits including 27 days of holiday (plus bank holidays), a comprehensive induction and training programme, and competitive pension scheme.

We are passionate about creating an inclusive workplace and aim to reflect the diverse communities we work with and positively encourage applications from all sectors of the community.

Three small words, one big difference - Caring, Expert and Quality.

Together we'll save and improve more lives than ever

Interviews are to be confirmed