Job overview
Medical Oncology Gastro-intestinal & Lymphoma Unit
Full time – 37.5 hours per week over 5 days per week.
Salary Scale: AfC6
Based: Sutton (Royal Marsden NHS Foundation Trust)
A very exciting opportunity has arisen in the GI & Lymphoma Unit at the Royal Marsden Hospital for a lead Data Manager for all Royal Marsden sponsored, Investigator lead, Clinical trials. At least 1 years’ experience working in Gastrointestinal Cancer and working on MACRO is essential.
This person will be experienced in development of clinical trial databases in MACRO, creating and annotating Case Report Forms (CRFs), specification of validation checks and the testing of each individual Electronic Data Capture (EDC) database.
The role will also be responsible for the creation and review of data management plans, CRF completion guidelines, guidance documents and templates making recommendations for change where appropriate.
Main duties of the job
We require a Clinical Data Manager to lead the Data Management for all Royal Marsden sponsored, Investigator Lead clinical trials running through the Gastro-intestinal & Lymphoma Research Unit, communicating proactively and effectively with study team members, providing updates on projects and ensuring data management milestones are met to ensure all trials open in a timely manner with data capture processes in place for the first patient to be recruited. This post will be based at the Royal Marsden Hospital, Surrey although flexibility will be
required to work in our London offices on occasion.
The experience and motivated post-holder will be exposed to a number of clinical trials, supporting the development of clinical trial databases in MACRO, creating and annotating Case Report Forms (CRFs), specification of validation checks and the testing of each individual Electronic Data Capture (EDC) database. The role will also be responsible for the creation and review of data management plans, CRF completion guidelines, guidance documents and templates making recommendations for change where appropriate.
Detailed job description and main responsibilities
For more information please refer to the job description and person specification:
Serving as the primary unit contact for data management for RM sponsored trials running through the GI &Lymphoma Unit, communicating proactively and effectively with the Trial team, ensuring data management milestones are met.
Assisting with the development of CRFs, assisting the programmers to define the individual trial specific database in MACRO, specify validation checks and perform validation of each programme
Create and review data management plans, guidance documents and templates, making recommendations for change where appropriate, including changes to accommodate study protocol amendments.
Assist with the review of clinical trial data ensuring ongoing data cleaning is managed effectively and efficiently, highlighting any issues that may affect data quality to the Trial Manager.
Person specification
Education/Qualifications
Essential criteria
1. Educated to Degree level in Computer Sciences
Experience
Essential criteria
2. Minimum of two years’ experience of Case Report Form development and Electronic Data Capture, including MACRO
3. Understanding of clinical trials and regulations governing clinical research
4. Thorough and proven understanding of the principles of data management and administration
5. Recent Good Clinical Practice training
Desirable criteria
6. Experience of working in the NHS
7. Experience of working in the field of cancer
Skills Abilities/knowledge
Essential criteria
8. Excellent administrative and organisational skills
9. Excellent IT skills including access, excel and power point
10. Excellent organisational and communication skills
11. Strong interpersonal skills to work within a multidisciplinary team
12. Strong time-management and problem solving skills under pressure to manage multiple priorities
13. Ability to oversee and streamline data collection tools and working practice for a large trials portfolio
14. Ability to work with large data sets
15. Ability to maintain adherence to written procedures
Desirable criteria
16. Good attention to detail
The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.
As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.
Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment.
Flu Vaccination – What We Expect of our Staff
At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.
The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.
Employer certification / accreditation badges
Applicant requirements
The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.