Data Manager
Job summary
An exciting opportunity has arisen for a Data Manager to join the Sarcoma Research Unit, supporting a growing portfolio of academic, grant-funded and sponsored clinical research studies.
The successful candidate will work closely with Trial Managers and research teams to ensure the accurate management, validation and reporting of study data, supporting study setup, delivery and regulatory compliance. The role will also contribute to the development of an RM-sponsored CTIMP and other innovative research projects.This is an excellent opportunity for an organised and motivated individual with experience in clinical research or data management to play a key role in delivering high-quality research that improves outcomes for patients with sarcoma.
If you are passionate about research and data quality, we would love to hear from you.
Main duties of the job
- Responsible for the management of data and tissue samples for clinical trials managed by The Royal Marsden/ICR as required.
- To support the clinical research team with study administration as required to ensure the efficient and successful delivery of clinical trials and other studies according to Good Clinical Practice (GCP), standard operating procedures (SOPs), trust policies and all applicable regulations and governance structures.
- Responsible for ensuring data is complete and managed in line with the protocol, data management plan and regulations.
- Responsibility for the day-to-day supervision, training and oversight of workload for Data Managers (DMs) to ensure data management is performed to required standards to meet all relevant SOPs and regulations.
About us
The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital.
At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.
At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification:
- Undertake data checking and generation of summary reports for trial data entered by research sites in line with the protocol, data monitoring plan, monitoring plan and requirements of oversight committees.
- Assist with the setting up of the trial master file (TMF) and with subsequent maintenance of the file. To liaise with trial managers and Good Clinical Practice (GCP) team regarding updates to the TMF as required.
- Assist with the preparation of investigator site files (ISF) and ensure site teams are aware of their responsibilities for the maintenance of the ISF at their site, as required.
- Liaise with staff at research sites to provide information and documentation and support the set-up, implementation of amendments and running of the trial at each site as required.
Person Specification
Education
- Educated to at least GCSE/A level (or equivalent)
- Knowledge of ICH/GCP guidelines
Experience
- Good understanding of medical terminology
- Experience in working with databases
- Experience of working in a clinical trial setting
Skills
- Excellent administrative and organisational skills
- Competence in research orientated PC software including Microsoft Office packages
- Excellent oral and written communication skills
- Good attention to detail
- Understanding and experience of clinical trials, UK Clinical trial regulations, GCP and regulatory framework
- Experience of data entry and data management
- Good level of spoken and written English
Other Requirements
- Ability to support and train team members
- Able to work on both sites and to be flexible to meet the needs of the role
- Willingness to travel within UK and occasionally overseas to attend meetings and conferences
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Employer details
Employer name
The Royal Marsden NHS Foundation Trust
Address
Royal Marsden Hospital Chelsea
Chelsea
SW3 6JJ
United Kingdom
Employer's website
https://www.royalmarsden.nhs.uk/working-royal-marsden