Clinical Data Manager Contract

Great opportunity for an experienced Data Manger to join an exciting organisation in Central London on a 3 month contract to support a database lock. We can consider part time too. 

Our client has an extensive global network of sites they work with to provide clinical trials to a range of sponsors and across various Therapeutic areas, although there is a focus on cardiovascular, haematology and oncology therapeutic areas. They also have a great technology platform that you will get to work on to support studies. 

As a Data Manager you will provide support and technical expertise in the management and processing of clinical data, within assigned projects to ensure that they are executed in efficiently, accurately to set timelines. The study is in close out so you will need to be able to lead data management activities to get queries resolved and assure high quality data ahead of data base lock and analysis. 

We can consider a range of experience for this role as it's urgent. You will need to work in their offices 3 days/ week in London. The role may be extended. 

Key Responsibilities:

• Report trial progress and outstanding issues.
• Staff training for all projects to which assigned; both direct involvement in training and supervision of staff assigned to training.
• To ensure that all data management operations are conducted to TRI SOPs; contribute to the ongoing revision/improvement of these SOPs.
• Creation of project specific documentation for assigned trials, i.e. the Data Management Plan and the Data Management File.
• Prepare database and edit check specifications.
• Creation and validation of Manual and SAS checks.
• Reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory).
• To perform verification and User Acceptance Testing of configured databases.
• Data cleaning activities.
• To review SAS listings/SAS tables.
• To create CRF and eCRF completion guidelines, EDC system manuals and access instructions.
• Production of information/reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendor.
• To liaise with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees (CEC) within clearly defined guidelines as determined by the Data Manager for matters concerning processing of data.
• Performance of QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects.
• Perform other duties as assigned.  The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive

OTHER SKILLS AND ABILITIES:

•  The job holder must be computer literate and numerate with a willingness to adapt to various computer systems.
• It is essential that the job holder works with close attention to detail and is questioning about the validity of the data being entered and has an ability to phrase data queries in an understandable and impartial manner.
• To have the ability to train new staff and to monitor their performance

REQUIREMENTS:

• Life Science Degree, Nursing qualification, or relevant industry experience.
• All candidates will need to have current and valid eligibility to work in the UK in order to be considered for this role.

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