Clinical Trials Data Specialist (XN06)

Job description

Job responsibilities

We are seeking a Clinical Trials Data Specialist to join our clinical trials team, which is part of the NIHR Leeds Biomedical Research Centre (Leeds BRC), to contribute to research within Work stream 2 (SpA Prevention) and R&I Spondyloarthritis Research Portfolio.

We are looking for candidates with demonstrable experience of clinical trials data management in an NHS Trust, University, pharmaceutical company or CRO.

In this role, you will be expected to work closely with coordinators, statisticians and programmers and to liaise with medical staff involved in spondyloarthritis trials.

The LBRC Work stream 2 works on a wide variety of clinical trials and translational studies in the field of musculoskeletal diseases.

The clinical trials data specialist works across multiple teams and projects. If you enjoy learning, are enthusiastic about data management and have great attention to detail, read on, this post may be for you.

PRINCIPLE DUTIES AND AREAS OF RESPONSIBILITY

The data specialist will

lead data management activities for allocated trials from set-up through to database lock

ensure database and documentation are delivered on time and in line with regulatory guidance, Good Clinical Practice and SOPs

produce or oversee database and CRF design specifications and testing, ensuring databases are fit for purpose

work closely with the trial management team, in particular programmers, statisticians, coordinators to deliver all aspects of the data management project in line with agreed timelines

actively participate in and lead allocated quality and improvement initiatives related to data management

train junior staff and participating site personnel

provide data management guidance to members of staff of all levels who not familiar with data management principles

may line manage junior staff

actively participate in and lead allocated quality and improvement initiatives related to data management

train junior staff and participating site personnel

provide data management guidance to members of staff of all levels who not familiar with data management principles

may line manage junior staff

We would particularly welcome candidates with experience of REDCap and/or MACRO or other eCRF data collection systems and programming skills.

Clinical trial databases and clinical trial data management

To produce and maintain design specifications for data capture tools and validations

To develop and/or provide advice on the specifications for any other databases or systems required for the capture or transfer of clinical trials data or samples

To test or oversee testing of clinical trials databases and other data capture tools to appropriate standards

Liaise with LBRC IT team for the set-up, running and successful delivery of the project portfolio within LBRC WS2 and LTHT Spondyloarthritis Research Portfolio

To perform and oversee data cleaning, verification, and validation.

To develop Data management plans, CRF completion guidelines and other manuals

In collaboration with the programming team, to contribute to the development of data query programmes that extract information from the designated datasets as required for reporting or cleaning purposes.

To actively participate in working groups and meetings as a data management representative and feedback relevant discussions and decisions to the department.

Sample management

To design specifications, testing and maintenance of sample tracking tools

To enter sample tracking information, as required.

Project management

To support the development of project plans for the implementation of databases and data management activity across the Leeds BRC and SpA Research Portfolio and be fully accountable for the subsequent data management elements of the project

To maintain and develop data systems, collating information from multiple sources and research sites across the UK prioritising and coordinating a response

To be the Data management representative on Trial management groups/Steering Committees, as appropriate

To liaise with Leeds BRC and SpA Research Portfolio Senior Management team and researchers in developing strong relationships with them to ensure key project milestones are delivered on time

Presenting findings based on study activity and performance, formulating appropriate action plans

To quickly identify potential problems and provide solutions to ensure that the project remains on time

Determine and escalate data quality issues as required, direct junior staff in response to findings

To ensure that training and support is provided to clinical and academic colleagues to ensure that the data capture tools that have been developed can be fully implemented Collects and quality checks data from multiple formal research programs on a daily basis, feeding back findings to the rest of the delivery team. To assist Senior management in implementation and reporting of suitable data management metrics

Compliance (Procedures, Quality Assurance, audit, reporting and maintenance of existing databases)

To maintain documentation of databases and data management plans to meet regulatory standards in line with relevant Good Clinical Practice requirements, guidance, as well as UK clinical trials regulations and Sponsor SOPs.

Provide input into the development of any new Standard Operating Processes and Procedures relating to data management

To assist the programming team in optimisation of data capture tools, methods and documentation across the Leeds BRC and R&I SpA Portfolio studies

To assist Trial coordinator in coordination activities, as required, such as remote and central monitoring

To participate in audits and inspections for allocated trials. Assist the team in development and implementation of corrective and preventive action plans.

Personnel management & Training

To train and mentor less experienced members of staff within own team and generally across the Leeds BRC and R&I SpA research teams in data management and data capture design. This may include provision of advice and guidance to non-data managers (e.g. Trial Coordinators) involved in data management activities.

To take part in the data management induction of new members of staff coming into Leeds BRC and SpA teams

To assist in the training of participating sites, in particular with respect to site initiations and the roll-out of electronic Case Report Forms.

To develop and review training materials for data managers

The post-holder will be educated to degree level or equivalent or be able to demonstrate relevant experience commensurate with this post. They would be expected to have experience of working in an organisation which includes interaction with multiple departments or organisations.

The post holder will be expected to show a thorough understanding of all legal requirements related to trials and must be familiar with GCP/ICH guidelines and the Declaration of Helsinki. The post requires evidence of relevant experience of Clinical Trials co-ordination and advanced data management skills.

Excellent communication skills and the ability to provide and receive complex information in relation to study design are essential for this role. Excellent organisational, negotiation and presentation skills are essential, as well as the ability to work on their own initiative and as a team player.

Person Specification

Qualifications

Essential

• Educated to degree level or equivalent, or be able to demonstrate relevant experience commensurate with this post.
• Evidence of on-going professional development

Desirable

• Experience of multi centre database management
• Clinical Trials Management

Skills & behaviours

Essential

• Excellent communication skills both verbal and written
• Attention to detail, Computer literate
• Experience of managing multiple complex projects simultaneously

Desirable

• Data base design experience

Other Criteria

Essential

• Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary), in compliance with Trust policy.
• Flexibility to work across different sites if required.
• Reliable.
• Enthusiasm.

Experience

Essential

• Experience of working in a clinical trials setting or health service administration at a senior level.
• Experience of maintaining electronic databases
• Experience of supervising a team of staff
• Knowledge and understanding of the need for and benefits of clinical research. Evidence of working in an organisation which includes interaction with multiple departments or organisations.
• Experience within a clinical trials setting
• Excellent presentation skills.
• Excellent IT skills
• Ability to work unsupervised
• Effective communication skills with all levels within multi-disciplinary team. Participate in and contribute to team discussions.
• Able to work on own initiative/ Proactive approach.
• Able to motivate self and other team members.
• Able to prioritise and manage time effectively.
• Professional attitude to work, diplomatic and calm under pressure.
• Effective communication skills, able to communicate at all levels and ability to provide and receive complex information in relation to study design.
• Strong interpersonal skills. Effective organisational skills

Desirable

• Project management Experience
• Experience of health service and in particular working alongside medical and nursing staff
• Knowledge of data protection issues Experience of study design including protocols and case report forms
• Experience of database creation
• Programming skills

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

Leeds Teaching Hospitals

Address

Leeds General Infirmary

Great George Street

Leeds

LS1 3EX

Employer's website

https://www.leedsth.nhs.uk/ (Opens in a new tab)