We are currently looking for an enthusiastic individual to work within the Research Delivery Team. You will have the opportunity to be a part of the multidisciplinary team including Research Nurses/Practitioners, Principal Investigators and the wider research teams at the Royal Surrey County Hospital, working with us to endeavour to make a difference to patient’s lives.
The role will involve assisting and supporting the Research team with clinical trial set-up and the retrieval, review and entry of clinical trials patient data using paper and eCRFs. The successful candidate should have a flexible approach to their duties and the ability to work both as part of the team as well as independently playing a key role in the development, initiation and data capture for national and international trials. The maintenance of accurate and comprehensive records is an essential aspect of this post.
You can demonstrate previous clinical experience having worked within a clinical setting and be familiar with medical terminology. You will work within the guidelines and policies for the conduct of clinical trials, ensuring high standards of practice in accordance with the principles of GCP. In addition you will have excellent communication, administrative and IT skills.
Main Duties
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As a Data Manager, you will play a pivotal role in the success of our clinical trials by overseeing the accurate, timely input and management of clinical trial data. You will be responsible for populating electronic and paper Case Report Forms (CRFs), managing patient recruitment databases, and creating essential source data worksheets and patient pathways in collaboration with the wider research team. A key part of your role involves maintaining robust tracking systems to monitor patient progress and trial financial implications, while actively utilising the Trust's key information. You will act as a primary point of contact for external trial sponsors and units, resolving complex data queries and preparing for crucial monitoring visits and regulatory audits. Beyond pure data entry, you will collaborate closely with research nurses, clinicians, and support departments (such as medical records, radiology, and pathology) to ensure comprehensive data capture, while professionally handling sensitive communication with patients. Additionally, you will support study set-up by assessing pre-study CRFs, creating data reports, managing digital image uploads, and organising the transport of clinical specimens when required.
Royal Surrey is a compassionate and collaborative acute and community Trust. Recognising that our 5000 colleagues are our greatest strength, we offer a comprehensive health and wellbeing program along with a commitment to developing and advancing your career. Our diverse and welcoming Royal Surrey family will ensure you that you feel valued from your initial interview through your entire tenure.
We are clinically led and provide joined up care by bridging the gap between hospital and community services alongside regional specialist cancer care. Our main acute hospital site is in Guildford with community hospital sites at Milford, Haslemere and Cranleigh. We provide adult community health services in homes across Guildford and Waverley.
The Care Quality Commission (CQC) have given us an overall rating of Outstanding.
Royal Surrey has a strong reputation and history to build on. We are proud of our achievements and we are investing in our colleagues through our commitment to supporting professional development as well as investing more than £45 million in our physical environment and new equipment in the next few years. There has never been a better time to join us.
Although it isn't the Trusts normal practice, adverts may close early, so you are encouraged to submit an application as soon as possible.
A video about the Royal Surrey - https://www.youtube.com/watch?v=R96pMboIYdo
Please refer to the full job descriptiojn & person spec.
As part of the team you will have the opportunity for personal and professional development and ongoing education with access to the Kent, Surrey and Sussex Clinical Research Delivery Network.
Operating strictly within ICH/GCP guidelines, Research Governance Standards, and Trust Data Protection policies, you will maintain meticulous filing systems, prioritise your workload to hit critical trial deadlines, and mentor data assistants as needed to drive network objectives forward.
Potential candidates should be able to demonstrate:
- A good understanding of data collection or clinical audit
- Good interpersonal and communication skills.
1. Data Management
- To be responsible for the input of clinical and other data necessary for clinical trial purposes:
- Checking all data is accurately populated, ensuring all empty data fields are completed to ensure correct analysis of trial
- Responsible for forwarding completed data and data queries to trials unit (sponsor)
- Maintain spread sheets/database on patient recruitment
- Maintenance of robust systems to track and monitor patient and financial progress through clinical trials.
- To be responsible for the electronic or paper entry of the Case Report Forms (CRFs) in line with the agreed timelines within the Clinical Trial Agreement (CTA) for commercial sponsors and local SOPs for Academic studies
- To ensure all patients questionnaire data fields are populated, to enable electronic capture or the hard copies to be forwarded to the sponsor as required by the research protocol
- Priorities workload to ensure specific deadlines, expected timelines and clinical importance are achieved.
- To be responsible for liaising with Clinical Trials Units (Sponsor) regarding data queries and for checking/resolving data queries
- To be responsible for liaising with commercial trial sponsors to ensure complex data issues are resolved
- To have an overall understanding of the activities associated with each trial that is allocated to the research team and financial implications
- To utilise the Trust’s Patient Administration System, Telepath, CRIS (Clinical radiology Information System) and other information systems.
- To produce reports of the numbers of patients in follow-up as requested by the other member of the Research Team
- To comply with the Trust’s policy on Data Protection, Confidentiality and security.
- To work to International Conference on Harmonisation Good Clinical Practice (ICH/GCP) and Research Governance Standard
- The creation of source data worksheets to reflect all data required at each study visit.
- Create patient pathways with the input from the wider research team for all new studies.
- Assess CRF’s pre study initiation to ensure accurate time estimates are used to assist with study set up.
2. Communication
- To work closely with the Research Nurses/practitioners and clinicians to ensure that all data are captured for patients on clinical trials and question missing fields.
- To establish communication lines and understand process with medical records department, radiology and pathology in order to obtain relevant medical records for those patients on clinical trials
- To attend Research related meetings and to contribute to the development of the Research Network.
- To deal sensitively and in a professional manner with patients in person and on the telephone
- To prepare for and attend commercial and NCRI trial sponsor monitoring visits or audit inspections by regulatory authorities
3. Other Duties
- Mentoring of data assistant where relevant
- To remain in contact with local and national organisations in order to keep up to date with relevant trials and data management issues
- Attend the National Institute for Health Research training programmes and other relevant education and training days/programmes as appropriate
- To work effectively to deadlines and prioritise work appropriately
- To organise transportation of clinical samples in a timely manner and liaise with couriers to arrange transportation of clinical specimens in the absence of the biological specimen co-ordinator.
- Uploading of digital images required by sponsors.
