job description

Cancer Research UK & King’s College London Cancer Prevention Trials Unit (CPTU) specializes in research to advance cancer prevention, early diagnosis and screening. We research the effectiveness, cost-effectiveness and technologies to improve existing screening programs and establish new ones.

Our portfolio of secondary (hospital) and primary (community) care trials includes:

• International multicenter randomized controlled trials on drug prevention of cancer often using drug redirection;

• Pragmatic testing of screening and diagnostic interventions;

• Trials of behavioral interventions in cancer prevention and screening;

• Testing of diagnostic/screening devices.

You will be the data analyst/lead for the BEST4 studies which are part of an exciting new project funded by Cancer Research UK and the National Institute for Health and Care Research, to find out if a test called Cytosponge can be used to reduce the number of deaths from esophageal cancer (CAO). The BEST4 screening study will recruit 120,000 participants, of which 40,000 will receive the Cytosponge on mobile units located in 5 regions of the UK. The BEST4 surveillance study (N=1900) will also investigate whether Cytosponge could be used as primary surveillance instead of endoscopy in patients with non-dysplastic Barrett’s esophagus. Trials will open for recruitment in 2023, so we are looking for an experienced and enthusiastic Data Analyst to support relevant activities.

You will be:

• Be responsible for all data management activities

• Interpret and analyze received data to generate illustrations and visualizations of project data that can be easily included in reports for key stakeholders

• Coordinate activities around attendee invitations and venue reservations and the use of a dynamic registration program

You will report to and be supervised by BEST4’s Clinical Project Manager. We appreciate your professional growth and you will have the opportunity to attend conferences and training.

This position is currently a hybrid job in response to COVID-19. For this reason, the job holder must be self-motivated and able to work independently. The incumbent is expected to be in the office approximately two days per week.

This position will be offered on a fixed-term contract until December 31, 2026

This is a full-time position – 100% full-time equivalent

Main responsibilities

• Be responsible for all data management activities

• Work with Chief Investigator, Trial Managers, Statistician and Database Developer to develop trial database (CDMA), data management and data monitoring plans

• Coordinate activities around the dynamic enrollment program to ensure that the sample is representative by age, gender and socioeconomic status to ensure that recruitment of the trial population reflects the characteristics and diversity of the british population

• Review data collection across trials to ensure we are collecting data consistently and appropriately to monitor equity, diversity and inclusion (EDI) within our research populations

• Oversee and manage the cleaning and validation of data received from sites according to data management plans; follow up on missing datasets and reports, if any

• Monitor KPIs

• Work closely with Cyted to monitor reports of lab results (quality control) to identify where re-training of the Cytosponge procedure might be needed

• Support trial managers in clinical database modification requests in liaison with the developer

• Provide datasets for analysis according to the statistical analysis plan

• Support work in multiple areas of trial operations, including assisting in the preparation and maintenance of up-to-date trial related documentation such as Trial Master and Site Investigator files, etc.

• Support the establishment and collection of passive monitoring data using health registers

• Assist in the education and training of testing personnel

• Represent the operations team at multi-stakeholder meetings and provide updates on trial progress and answer questions about the trial

• Develop and update written procedures for test data processes as required

• Work, as appropriate, with lead investigators, grant co-applicants, data managers, monitors, clinicians, statisticians, and external agencies and vendors on a daily basis to ensure that milestones projects are achieved

• Ensure that trials are conducted according to protocol

• Troubleshoot issues and respond to trial management requests both inside and outside the unit

• Ensure confidentiality on all questions and information obtained during employment

• Ensure the project complies with applicable regulatory requirements including Human Medicines (Clinical Trials) Regulations, Data Protection Act, Human Tissue Act 2004, UK policy framework for Health and Social Care Research and Health and Social Care (National Data Custodian) Act 2018

• Work independently to achieve project reporting milestones

• Undertake administrative and other tasks related to the CPTU project or objectives that are reasonably foreseeable, as agreed with the line manager

The above list of responsibilities may not be exhaustive and the post holder will be required to undertake the duties and responsibilities reasonably expected within the scope and classification of the post.

Skills, knowledge and experience

Essential criteria

1. Undergraduate degree in a related field of study or equivalent clinical research/data management experience

2. Excellent numeracy and precision skills with a high level of attention to detail

3. Understanding of regulatory requirements for clinical research

4. Excellent written and verbal communication skills enabling effective communication with a range of clinical, academic and non-academic staff through a variety of media

5. Experience working with complex databases and data management, within the NHS, academia or commercial industry, ideally in a research or clinical setting using confidential or sensitive information

6. Experience working with complex relational databases, with demonstrable skills in data transfer, data import, data fusion/multi-source linking, data validation, extraction and reporting

7. Experience with clinical research electronic data entry systems (i.e. REDCap, MACRO, Inform or custom

8. Possess an understanding of database structure and data management processes

9. Demonstrated ability to work independently to achieve project milestones, using problem-solving skills to take a pragmatic and flexible approach while maintaining compliance with policies and regulations

10. Strong working knowledge of MS software including Excel

Desirable criteria

1. Ability to use programming languages ​​such as R or Python for data communication

2. Understanding of the key principles of the legislation which defines when information about individuals may be processed for research purposes and the safeguards which must be in place, including the Data Protection Act 2018 and the UK General Data Protection Regulation. data protection (GDPR)

3. Ability to build successful relationships, collaborate within a cross-functional team and maintain a positive work environment

Sean N. Ayres