Clinical Trials Data Manager/Monitor, Cancer Prevention Trials Unit

Job description

The Cancer Research UK & King’s College London Cancer Prevention Trials Unit (CPTU) specialises in research to advance cancer prevention, early diagnosis and screening.
We perform research on efficacy, cost-effectiveness and technologies to improve existing and establish new screening programmes.
Our portfolio of both secondary (hospital) and primary (community) care trials includes:
Multi-centre international randomised controlled trials of medicinal prevention of cancer often using drug repurposing;
Pragmatic trials of screening and diagnostic interventions;
Trials of behavioural interventions in cancer prevention and screening;
Trials of diagnostic/screening devices.

You will be the data manager for two new trials funded by Yorkshire Cancer Research. This includes the FINESSE trial (FINasteride Evaluation in Surveillance for proStatE cancer), investigating whether finasteride, an existing drug that slows prostate growth and reduces the protein prostate specific antigen levels, can be used to improve active surveillance by reducing the number of men who undergo surgery or radiotherapy needlessly. And a further project investigating screening for bladder cancer, which will involve inviting 6,000 patients to undertake home urine testing in 3 separate cohorts spanning an existing screening trial population, primary care and secondary care.
 
Lead the data management and monitoring activities of the projects
Provide practical assistance to stakeholders to ensure complete and accurate data collection and reporting
Interpret and analyse data received in order to generate simple illustrations and visualisations of the project data that can be easily comprehended in reports for key stakeholders
 
You will report to and be supervised by the Clinical Project Manager at CPTU.  You will be required to develop strong working relationships with the investigators, database developers, trial coordinators and other data coordinators across King’s. Your contributions will be recognised through authorship on publications. We value your professional growth and you will have opportunities to attend conferences and training. 
 
This post is currently home-working in response to COVID-19. For this reason, the post holder must be self-motivated and be able to work independently.

This is a full-time post, a fixed-term contract for 3 years.

Key responsibilities

Key tasks:

• Lead the data management and monitoring activities of the projects 
• Provide practical assistance to stakeholders to ensure complete and accurate data collection and reporting Interpret and analyse data received in order to generate simple illustrations and visualisations of the project data that can be easily comprehended in reports for key stakeholders
• Work with the chief investigator, trial managers, statistician and database developer to develop the trial data management and monitoring plans
• Support the database developer with the development of the REDCap Clinical Data Management Applications (CDMA)
• Oversee the project-specific NHS Digital searches and coordinate data extractions/downloads
• Support the set-up and collection of passive follow-up data using health registries
• Perform site monitoring visits at participating centres to verify study data and protocol compliance
• Act as the primary contact for receipt of large datasets from the key project stakeholders
• Manage the clinical databases change requests in liaison with the trial managers and developer
• Request screening log data from sites, query as required and enter data into the CDMAs
• Oversee and manage the cleaning and validation of the data received from the sites according to the data management plans; following-up on missing datasets and reports when appropriate
• Provide datasets for analysis as per the Statistical Analysis Plan
• Ensure the project complies with applicable regulatory requirements, including the Data Protection Act, the EU General Data Protection Regulation and Good Clinical Practice
• Proactively review data management procedures for the projects and recommend solutions
• Assist in preparation and/or maintaining up-to-date trial related documentation such as Trial Master and Site Investigator Files
• Assist the trial managers in the preparation of progress reports (e.g. for regulatory and funding bodies and Trial Management Group) as required
• Work closely with the trial managers to ensure data is collected from participating sites in accordance with the data management plan
• Raise data queries, and liaise with centres to resolve them
• Communicate findings from monitoring visits to the local investigators and provide re-training as required
• Liaise and negotiate with institutions holding external data sources such as NHS Digital and NCRAS
• Attend and contribute to team meetings (Unit and Trial level)
• Contribute to departmental working groups e.g. the Data Management Working Group
• Work with the project teams to identify and manage risks to the success of the projects by monitoring for quality assurance
• Plan timelines and work with key stakeholders to ensure database management systems are maintained and executed according to agreed project milestones
• Work independently to meet projects reporting milestones
• Undertake presentations/demonstrations/training as required
• Undertake such administrative and other duties linked to the project or to the objectives of the CPTU as are reasonably to be expected, as agreed with line manager
• Based in an office but may also attend conferences, seminars and training courses outside the organisation
• Perform on-site monitoring visits to participating sites
• Attention to detail and excellent written and verbal communication skills are essential
• Remote working will be expected at the start of the role due to Covid-19
• Show consideration to others and maintain good working relations with other departments
• Be aware of the issues relating to working in an open-plan environment and the potential effect that this has on both one’s own work, and that of others
• Multi-centre international randomised controlled trials of medicinal prevention of cancer often using drug repurposing; 
• Pragmatic trials of screening and diagnostic interventions; 
• Trials of behavioural interventions in cancer prevention and screening; 
• Trials of diagnostic/screening devices.

Skills, knowledge, and experience

Essential criteria

• Degree or equivalent experience in clinical research/data management
• Excellent numeracy and accuracy skills with a high level of attention to detail
• Understanding of regulatory requirements pertaining to CTIMPs
• Excellent written and verbal communication skills enabling effective communication with a range of clinical, academic and non-academic staff through various media
• Experience of 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
• Experience of working with complex, relational databases, with demonstratable skills with data transfer, data import, data merge/multiple source linkage, data validation, extraction and reporting
• Demonstrated ability to work independently to achieve project milestones, using problem solving skills to take a pragmatic and flexible approach whilst maintaining adherence to policies and regulations
• Willingness and ability to travel within England to Hospitals to accommodate the needs of the project

Desirable criteria

• Solid working knowledge of MS software including Excel
• Understanding of the key principles of legislation which sets out when information about people can be processed for research and the safeguards that must be in place including Data Protection Act 2018 and the EU General Data Protection Regulation (GDPR)
• Experience of central and on-site monitoring
• Ability to build successful relationships, collaborate in a cross-functional team and maintain a positive work environment

Further information

Candidates should be aware that this role will initially be home-based with remote working due to Covid-19. Interviews will take place via MS Teams or Zoom.