Loading...
Share this Job

Data Manager

Requisition ID:  3341
Location: 

Newcastle, GB

Contract Type:  Open Ended
Posted Date: 

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: £21,814.00 - £23,067.00 

Closing Date: 28 February 2020

 

The role

 

An exciting opportunity has arisen for a Data Manager to be based across the Clinical Research Facility (CRF) in the RVI and the Clinical Ageing Research Unit (CARU) at the Campus for Ageing and Vitality.

 

We require a well-motivated and flexible Data Manager to accurately collect and co-ordinate the data created by the Research Team.  A meticulous attention to detail is paramount.

 

It is essential that applicants have proven experience of working and/or education in a medical environment and have a thorough understanding of medical terminology.  You should have excellent IT skills, preferably holding the European Computer Driving Licence qualification or equivalent.  The candidate must also be willing to undertake further training and education.

 

Applicants must have excellent communication and interpersonal skills as liaison with many other disciplines within, and outside the unit is an integral part of this role. 

 

This is a full time role and the successful applicant will need to have an NHS Research Passport in place before employment can commence.

 

Enquiries about this post can be made through Mandy Jarvis, Operations Manager via email (mandy.jarvis@ncl.ac.uk).

 

Further details about CRF and CARU can be found via the following links:

CRF:  https://www.ncl.ac.uk/crf/rvi/

CARU:  https://www.ncl.ac.uk/caru/

                                   

Key Accountabilities

 

  • Transcription of data from patient records to Case Report Forms as required by a specific clinical trial.  Patient records may include medical notes (often handwritten), laboratory test results, or data acquired from questionnaires patient diaries etc.  Case Report Forms may be based on an electronic or paper system.
  • Liaising with a range of internal and external interested parties such as senior clinical and non-clinical staff, funders, PI’s and nursing staff,  reviewing patient records to proactively and independently retrieve required data.  Will need to access external patient records and Hospital information systems where necessary.
  • Ensure that all data reporting requirements both internally and externally are met, including responding to routine deadlines and ad hoc information requests.
  • To take responsibility for all data security and integrity in line with University and Trust policies.
  • Ensure that University and Trust policies in relation to Data Protection/Caldicott Guidelines are adhered to, including checking that all data capture systems used comply with this.
  • Collation of information and paperwork for reporting of Serious Adverse Events (SAE’s) that may occur during the course of the clinical trial at the local (Newcastle) site.  This includes ensuring the relevant information is available for the completion of forms, obtaining relevant signatures and sign-off from a clinical member of the team and ensuring the reporting process is followed as required for the specific clinical trial (e.g. faxing to a central point)
  • May be delegated by clinical team members to register and randomise patients into clinical trials
  • Ensuring patient investigation results are received, seen by the relevant member of the study team (usually a clinical or nursing member of the clinical trial team) and ensuring they are recorded and filed appropriately.
  • Be responsible for anticipating requirements for and ordering supplies of data capture documentation.  Liaise with the nursing and clinical team to maintain sufficient stocks of clincal equipment required for individual trials.
  • To act as a point of contact for regional, national and international data queries.
  • To liaise regularly with counterparts nationally to ensure that there is consistency of approach in data collection to facilitate audits across the centres in the UK.
  • Organise meetings for visit of monitors and/or auditors.  This will include arranging meeting rooms, ensuring relevant patient notes are available, ensuring the site study file is accurate and up to date.  Act as the point of contact for their visit to the site
  • To routinely audit data quality on the manual and electronic systems within the department to ensure that high standards are met and comply with University and Trust external governing bodies’ requirements
  • Assist the Clinical Trials Co-ordinators in all aspects of maintaining records of patients on trials and the regulatory issues that govern the management of clinical trials.
  • Help with the preparation for, and facilitation of, audits and/or inspections
  • Ensure archival of closed study documentation is completed in accordance with local policy
  • Provide administrative support when needed as directed by their line manager
  • Take responsibility for continuous improvement of research administrative processes and target achievement, in line with changing regulations and faculty strategy.
  • Take responsibility for identifying own learning needs, including identifying appropriate courses to ensure up to date knowledge in the regulations governing clinical research and research data.
  • Be aware of and take responsibility for working in accordance with applicable regulations and guidance inlcuding the International Conference on Harmonisation (ICH) Guidelines on Good Clinical Practice, UK Regulations on Clinical Trials, Data Protection Act and Research Governance Framework for Health and Social Care.
  • To assist with other research administrative functions within the department to provide cover for staff absence due to holidays and sickness.
  • There is not normally any responsibility for managing other staff but there may be a need to supervise any temporary support required to assist with special projects or events
  • Required to make decisions, using trial specific tools, when transcribing data into Case Report Forms.  This will be in relation to clinical information and will involve relating the request for information to what is actually recorded in the notes.
     

The Person

 

Knowledge, Skills and Experience

 

Essential

  • Knowledge of medical terminology
  • Knowledge of University and Trust policies regarding Data Protection Act and the Caldicott Guidelines.
  • Experienced in all aspects of Microsoft Windows applications
  • Able to concentrate on routine tasks whilst maintaining attention to detail
  • Excellent interpersonal and communication skills (both written and verbal)
  • Good time management skills
  • Ability to prioritise workloads
  • Ability to accurately transfer data from one medium to another using both paper based and electronic data capture
  • Previous Database and Data Management experience
  • Evidence of Admin and Clerical experience
     

Desirable

  • An understanding of Good Clinical Practice (GCP) and other regulatory processes involved in clinical trials
  • Demonstration of a knowledge of Serious Adverse Event (SAE) procedures
  • Knowledge of E-Record
  • Experience within NHS/clinical research

 

Attributes and Behaviour

 

Essential

  • Meticulous about following processes and procedures and able to organise workload and paperwork accordingly
  • Self motivated and able to work with minimum supervision
  • Willing to undertake personal development training as required
  • Flexibility to work unsocial hours when urgent data capture/resolution is necessary
  • Able to work flexibly across both CRF and CARU sites
     

Desirable

  • An interest in clinical research

 

Qualifications

 

Essential

  • Educated to A level standard or equivalent
     

Desirable

  • European Computer Driving licence qualification or equivalent

 

 

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: 3341