The APIPPRA and ALTO studies are multi-centre clinical trials that are investigating whether biological therapy can delay or prevent the onset of rheumatoid arthritis in subjects deemed to be at high risk of developing the disease. The post holder will be responsible for providing the data management for the APIPPRA and ALTO Trials as well as assisting the Trial Manager to undertake a range of trial management tasks as required for delivery of these clinical trials.

The successful applicant will be responsible for the production of the APIPPRA and ALTO Data Management Plans and associated Data Management Reports which will be produced from exports from the electronic data capture system. The post holder must have a flexible approach to work and enjoy having regular contact with a variety of research professionals involved in the study across the UK and the Netherlands.

Communication & Networking:

• Communicate complex information both orally and in writing
• Participate in project meetings as required
• Ensure clear communication at all times to a multidisciplinary study team consisting of clinical research and laboratory staff and statisticians

Decision Making, Planning and Problem Solving:

• Use initiative and creativity to resolve occurring issues that might arise with the study dataset
• Demonstrate initiative and be proactive within his/her domain of responsibility.
• Decide on a schedule for when Data Management reports should be run and liaise with the Trial Manager to set up regular meetings to go through the findings and assist with finding solutions/disseminating information.
• Assist the Trial manager in setting up processes and procedures to aid the management of the study
• Deal with any problems which may affect the achievement of data management objectives & deadlines
• Identify data management issues that require onward reporting to the Trial Manger and/or Chief Investigator
• Produce a data management plan for the study in collaboration with the study team and statistician
• Monitor data entry into the study (excluding SDV checking as this is done by the Trial Manager / Monitor)
• Produce reports on timelines to data entry, recruitment, missing data, visit timelines, database warnings, discrepancy levels, outliers and circulate these reports to the trial manager and CI as needed
• Inform trial manager of any issues within the database design which may need to be raised with the programmer
• Monitor data flow through the study
• Liaise with the trial statistician to plan appropriate logic checks on data
• Liaise with the trial statistician to ensure they can access appropriate data to produce consort diagrams and reports
• Attend Trial Management Group meetings
• Ensure concomitant medication and AE data is appropriately coded by site staff, linking in with CI as appropriate
• Advise the CI and Trial Manager promptly if any concerns about data quality are identified
• Produce a final data set for the analysis and manage the database lock process within the eCRF
• Ensure the completion of data management tasks in a timely manor
• Any other duties as directed by direct line manager

Assist the Trial Manager with:

• The acquisition and distribution of relevant study documentation
• The organisation of meetings and training days during the setting up phase of study sites and meetings of all the committees
• Taking minutes
• Establishing and maintaining the study master files and investigator site files in accordance with ICH GCP and Research Governance
• The preparation and submission of ethics and R&D approval forms
• The acquisition and distribution of relevant study documentation
• The organisation of archiving/reconsolidation of trial documentation
• Preparation of data for database lock
• Assist the Trial manager with the drafting of relevant study reports
• Assist the Trial Manager with the reporting of safety data
• Help develop processes to aid the management of the study
• General clerical and office management duties including maintaining efficient study filing systems
• Maintain sufficient stocks of documentation and equipment required for study (e.g. CRFs, Questionnaires,  sample packs)
• Ensure sites have relevant study materials (site files, sample packs etc.)

• Ensure clear documentation with regards to conventions, data changes, errors and correspondence with collaborators

Analysis & Research:

• Generate Data Management reports from data extracts from the study database using appropriate data manipulation packages (MS Excel, SPSS, STATA, R etc)

• Work with the study team to ensure planned data management activities are conducted in a timely manor

• Maintain a library of primary publications for validated measures being used within the study

• Manage data extraction request process from the eCRF

Use initiative and be proactive about learning new skills relevant to the prosecution of clinical trial

Key responsibilities

• To draft a data management plan for the study with input from the wider trial team including the study statistician and Chief Investigator
• To implement the data management plan during the course of the study so as to ensure the completeness, accuracy and consistency of the study data
• To support the trial manager with maintaining efficient and responsive administrative and data management processes to ensure the smooth and effective conduct of the study
• Collaborate with the multidisciplinary study team and problem solve data management issues 

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

Skills, knowledge, and experience

​Essential criteria

• Graduate or equivalent
• Proven knowledge or willingness to learn about rheumatic diseases
• Computer literate with experience in using Microsoft Word, Excel and  preferably familiar with Microsoft Access
• Excellent analytical and organisational skills
• Ability to solve problems, plan ahead and able to prioritise
• Demonstration of attention to detail
• Good written and oral communication skills
• Able to work in a multidisciplinary team
• Experience of handling data
• Flexible and adaptable approach to work
• Willingness to travel to hospitals in the UK and the Netherlands

Desirable criteria

• Knowledge of ICH GCP and R&D governance
• Experience of working in clinical research