Adult SMA Reach Data Manager

This is an exciting opportunity to join the world-renowned John Walton Muscular Dystrophy Research Centre (JWMDRC) at Newcastle University, participating as a data manager in the Adult SMA REACH project. Adult SMA REACH is an NHS sponsored academic observational study, collecting clinical data and outcome measures from adult Spinal Muscular Atrophy (SMA) patients. Adult SMA REACH is also colleting data for the Manage Access Agreement of two SMA treatment., The main purpose of the Data Manager is to take responsibility for managing the data collection for the Adult SMA REACH Pregnancy study. Day-to-day management of the data collection service involves (1) training sites in data collection and supporting sites through the data collection process; (2) supporting data monitoring and query resolution (3) ensuring that all the relevant governance documentation is in place, (4) supporting in the design of eCRF. The data manager will also assist other members of the Adult SMA REACH network in collating data for the project., Day-to-day management of the Adult SMA REACH data collection project and associated datasets and databases
Liaising with external data managers, clinical trial personnel and senior clinical staff, to review data and to retrieve and check required data proactively and independently
Assist the Project Manager in establishing and updating all relevant legal documentation (e.g., data transfer agreements) required by Adult SMA REACH for the collection of data
Liaising with computer programmers and application developers to ensure smooth and efficient management of Adult SMA REACH data
To act as a point of contact for regional, national, and international data queries
Transcription of data from paper case report forms and laboratory reports to our in-house database as required for this project. Patient records may include medical notes (often handwritten), complex laboratory test results, or data acquired from other sources
To routinely audit data quality on the manual and electronic systems within the Adult SMA REACH network to ensure that high standards are met and comply with University and Trust and external governing bodies' requirements
Help with the preparation for, and facilitation of, audits and/or inspections
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 the data capture system used comply with this
Provide administrative support when needed as directed by their line manager
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 including 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 administration functions within the project to provide cover for staff absence due to holidays and sickness

Must be experienced in all aspects of Microsoft Windows applications
Excellent interpersonal and communication skills (both written and verbal)
Team membership skills within multidisciplinary research teams
Good time management and able to demonstrate the ability to prioritise workload
Ability to accurately transfer data from one medium to another (using paper based and electronic data capture)
Database and/or data management experience, especially data monitoring
Knowledge of research environment
Experience with NHS/clinical research would be a significant advantage
Knowledge of biology, genetics, or neurology
Knowledge of University and Trust policies regarding Data Protection Act and the Caldicott Guidelines
An understanding of Good Clinical Practice (GCP) and other regulatory processes involved in clinical trials would be an advantage

Attributes and Behaviour
Able to concentrate on routine tasks whilst maintaining attention to detail
Meticulous about following processes and procedures and able to organise workload and paperwork accordingly
Self-motivated and able to work with minimal supervision
Willing to undertake personal development training as required
May be occasionally required to work unsocial hours when urgent data capture / resolution is necessary
Experience/evidence of ability to work on own initiative
Desirable
An interest in clinical research would be beneficial

Qualifications
First degree in relevant field (e.g., medical sciences or another health-related field) or equivalent qualification (e.g., associates or diploma degree) or extensive relevant work experience

Newcastle University is a global University where everyone is treated with dignity and respect. As a University of Sanctuary, we aim to provide a welcoming place of safety for all, offering opportunities to people fleeing violence and persecution.

We are committed to being a fully inclusive university which actively recruits, supports and retains colleagues from all sectors of society. We value diversity as well as celebrate, support and thrive on the contributions of all of our employees and the communities they represent. We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams, we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.

At Newcastle University we hold a silver Athena Swan award in recognition of our good employment practices for the advancement of gender equality. We also hold a Race Equality Charter Bronze award in recognition of our work towards tackling race inequality in higher education REC. We are a Disability Confident employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme.

Salary: £29,605 to £30,487 with progression to £32,982 per annum

Newcastle University is a great place to work, with excellent benefits . We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you.