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Clinical Data Manager

2 months ago

Cambridge, Canada NHS Blood and Transplant Full time

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 lead for one or more trials within the Clinical Trials Unit (CTU) portfolio, with responsibility for data entry and validation. Your responsibilities will include:-

Testing and maintaining project specific clinical databases and case report forms, working as part of the trials team

Being involved with other members of the trials team to create the database design/specification (from the trial protocol) and subsequently with creating the database using OpenClinica (our database management system) Generating and resolving data queries and providing regular feedback to the Clinical Data Services Manager and the rest of the trial team, at trial team meetings, for the studies you are responsible for, representing the data management aspects of the trial and raising any DM issues as appropriate. Liaise with site research staff regarding data queries – sometimes requires tact and persistence Provide ongoing support to the data entry staff at sites, including providing technical assistance and advice by email or telephone. Producing reports and graphs showing patient recruitment into trials as required. Acting as mentor to the Junior Clinical Data Managers, to train and supervise as required

About You

Experience and Knowledge

Trained and experienced in the use of one or more clinical trial database management systems Experience of inputting data into clinical trial databases, extracting data and data query management Knowledge of NHS Research Governance ICH – Good Clinical Practice guidelines Experience of setting up and maintaining remote electronic data capture filing systems Experience of resolving a range of complex scientific/ technical problems

Qualifications and Training

Honours degree in a relevant science/healthcare subject and/or equivalent body of knowledge related to a scientific/healthcare field or equivalent experience gained working in a data management role