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Data Manager

Requisition ID:  1038
Location: 

Newcastle, GB

Contract Type:  Open Ended
Posted Date:  05-Nov-2019

We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.

 

Salary: £30,942 - £32,817 

Closing Date: 19 November 2019

 

We have an exciting opportunity for a Data Manager to join our successful UK CRC registered Clinical Trials Unit. 

The successful candidate will be responsible for the design, set-up, programming, testing and management of computerised databases for the capture and management of data across a portfolio of clinical trials (including electronic remote data capture and randomisation systems).  You will also be responsible for ensuring data integrity and confidentiality of databases together with secure back up of all trial data.

This demanding post requires an enthusiastic, proactive and motivated individual with experience of data collection in a research context, database design and data checking, and reporting. 

The post will support trials in both Newcastle and in our hub at The James Cook University Hospital. The post holder will work at both sites depending on the needs of individual trials and NCTU. 

Informal enquiries may be made to Mandy Jarvis via e-mail to Mandy.jarvis@ncl.ac.uk

Further information about the NCTU can be found via the following link:  http://www.ncl.ac.uk/nctu/about/

 

The Role

The post holder will work with Chief Investigators, trial teams, database providers and others as appropriate to ensure the smooth running of all data aspects of NCTU Trials.  They will be responsible for the design, set-up, programming and management of computerised databases for the capture (including electronic remote data capture and randomisation systems) and the management of data within these, across a portfolio of clinical trials. The post holder will be responsible, with trial managers and trial statisticians, for identifying processes to ensure the highest level of data integrity and will be responsible for ensuring data is suitable for statistical analyses.  These systems and data will meet the quality standards expected for reporting to regulatory bodies and in accordance with all applicable legislation and Good Clinical Practice guidelines.  They will be proactive in their approach to work.

 

There are currently approximately 50 active trials being conducted by NCTU. NCTU works with multiple trial sponsors, locally, nationally and internationally and from two main hubs in Newcastle and South Tees. Chief Investigators, Principal Investigators, and Co-Investigators are located throughout and beyond the University. The post holder will be expected to work at both sites depending on the needs of individual trials and NCTU.

 

Key Accountabilities

  • Design, develop, test and maintain databases and data capture systems for clinical trials documenting each element in line with relevant SOP’s using one or more proprietary Clinical Data Management System packages (e.g. MACRO, Red Pill).
  • Design, develop, test and maintain randomisation systems for clinical trials documenting each element in line with relevant SOP’s using one or more systems (e.g. Sealed Envelope).
  • Design, develop, test and maintain other databases (e.g. Access) to support the administration of clinical trials
  • Enable accurate, complete and timely entry of all study data
  • Work closely with the trial management group in contributing to the design of data collection forms
  • Oversee the collection and collation of data collection forms from participating centres and ensure the input of this data onto computerised databases as needed
  • Work closely with the trial manager and trial statistician to perform regular and timely data cleaning procedures, and quality controls to ensure that all trial data is accurate, complete and timely, identifying and following up any data omissions or queries, identifying potential problems and taking appropriate action
  • Ensure good working relationships between NCTU and its clinical, academic and other partners and collaborators
  • Prepare data for analysis as required by the statistician including coding as required (e.g. MedDRA)
  • Prepare data management plans and ensure accurate and thorough documentation of all data management activities in accordance with applicable legislation and current standard operating procedures
  • Provide data to the Trial Management Group to facilitate the preparation of progress reports for Funders, Ethics Committees, Trial Steering Committees, Independent Data Monitoring and Ethics Committees, and other bodies, performing basic descriptive analyses of data, and presenting results in a format suitable for reporting.
  • Assist in the preparation of data and materials for publication and/or presentation at scientific meetings or in scientific journals
  • Give presentations and provide training on the effective use of data capture systems including development of trial specific user manuals
  • Ensure studies are conducted in accordance with GCP and other applicable legislation for Clinical Trials, and the General Data Protection Regulation
  • Ensure secure back up of all trial data
  • Contribute to, and lead on, writing and reviewing of SOP’s and policy documents on data collection and management systems and processes, including the review of quality improvement and other related initiatives
  • Be able to plan and organise own workload and supervise that of others when required 
  • Use initiative while being aware of circumstances which require the involvement of CI’s, trial statisticians and trial managers.
  • Work with Chief Investigators an the wider research team in planning data collection systems and data management
  • Attend internal and external meetings as the expert in database and data management and develop close and effective working relationships with CI’s, PI’s, statisticians, health economists, other specialists and the trial management team
  • Contribute to internal NCTU staff training regarding data collection management systems, data management, randomisation systems and related processes
  • Any other duties, appropriate to the grade, which may be required from time to time by the NCTU

 

The Person

Knowledge, Skills and Experience

Essential

  • High levels of literacy and numeracy
  • Knowledge of good data management principles
  • Evidence of ability to set up, maintain and manage an effective research data management system, which produces reports and raises queries e.g. web-based CRF
  • Excellent IT skills including the use of the Microsoft Office Package
  • Ability to prioritise and manage workload using your initiative as required
  • Ability to make independent decisions and to work independently, alongside excellent team working skills
  • Working knowledge of regulatory and governance requirements for clinical trials in the UK
  • An understanding of the requirement of data protection regulations, the need for confidentiality and the ability to work to these
  • Appropriately handle confidential and sensitive information
  • Experience of database design
  • Experience of data management, data checking, data cleaning and reporting
  • Excellent organisational and administrative skills

 Desirable

  • Knowledge and hands-on experience of statistical software
  • Knowledge and hands-on experience of SQL programming
  • Knowledge and hands-on experience of Clinical Data Management Systems (e.g. MACRO)
  • Knowledge of Clinical Trial Methodology
  • Experience of data analysis
  • Experience of working on an interventional clinical trial
  • Experience of working in a University or NHS environment
  • An understanding of data collection in an NHS environment

 

Attributes and Behaviour

  • Excellent interpersonal skills
  • Excellent attention to detail
  • Excellent communication skills
  • Flexible approach to working
  • Willingness to travel to trial sites and to trial meetings as required
  • Willingness to work at each of the two NCTU sites located in Newcastle and South Tees Hospitals NHS Foundation Trust

 

Qualifications

 Essential

  • Degree in a relevant subject (or equivalent relevant experience)

 Desirable

  • Higher degree in a relevant subject

 

Newcastle University is committed to being a fully inclusive Global University which actively recruits, supports and retains staff from all sectors of society.  We value diversity as well as celebrate, support and thrive on the contributions of all our employees and the communities they represent.  We are proud to be an equal opportunities employer and encourage applications from everybody, regardless of race, sex, ethnicity, religion, nationality, sexual orientation, age, disability, gender identity, marital status/civil partnership, pregnancy and maternity, as well as being open to flexible working practices.

 

Requisition ID: 1038