Royal Papworth Hospital NHS Foundation Trust

Clinical Trial Data Manager

This job is now closed

Job summary

This role is integral to the data management team within Papworth’s Trials Unit Collaboration (PTUC) and will be based in the new Heart and Lung Research Institute, situated next to Royal Papworth Hospital on the Cambridge Biomedical Campus.

It is an excellent opportunity to utilise your clinical trial data management skills for all study types, including Investigational Medicinal Product (IMP), devices and multi-centre studies. Working at all stages of studies, from protocol design to database lock.

In this post you will be responsible for designing, implementing and maintaining database systems and resources for the recording of clinical trials data, ensuring that they are compliant with appropriate regulatory requirements.

You will also work closely with PTUC’s statisticians to provide support to the design, monitoring, and analysis of data sets (using R). Working as a liaison between the statisticians and the data management team, to improve data analysis.

You be required to assist with the ongoing development of our clinical trials data management service to reflect changes to regulatory requirements and to improve data quality and integrity, including writing SOPs and related guidelines. Line management of junior department staff is an expectation of this role.

Main duties of the job

This post suits an individual with knowledge of building studies on EDC systems, and experience in relational databases, SQL and programming. The post-holder requires excellent technical knowledge, good organisational and time management skills, with problem-solving ability. Excellent communication skills are essential as the post holder will have to communicate with technical and non-technical colleagues.

You will:

Be responsible for development and validation of new databases, plus revision of existing databases (OpenClinica).

Assist in development and testing of new processes and systems for the management of data capture within clinical trials.

Provide support in ensuring that Data Management services meet the standards required to maintain UKCRC accredited Clinical Trials Unit status and MHRA requirements.

Collaborate closely with researchers to support the analysis of data; be responsible for producing reports, summaries and listings of safety and efficacy data for data monitoring committees.

Work directly with the statisticians, to provide checked and cleaned datasets for analysis of trial data and contribute towards the statistical design, monitoring, analysis and routine analysis of data sets.

Design, development and implement training packages for clinical trials personnel and Trust/collaborating researchers.

About us

Royal Papworth Hospital NHS Foundation Trust is the UKs leading heart and lung hospital, delivering care to more than 50,000 patients a year in its new state-of-the-art hospital in Cambridge.

It performs the most heart and/or lung transplants in the UK and carried out the UKs first successful heart transplant in 1979. It also offers emergency heart attack treatment, sleep centre care and is one of just five centres nationally for those in severe respiratory failure. Based on the Cambridge Biomedical Campus the largest centre of medical research and health science in Europe the Trust is at the heart of treatments of the future.

Royal Papworth became the first hospital trust in the country to be rated outstanding in all five areas assessed by the Care Quality Commission - a rating it still holds today.

The Trust holds its values of compassion, excellence and collaboration at its core, and all colleagues joining the team are expected to uphold these in their day-to-day roles and interactions.

Royal Papworth is proud of its diverse workforce and encourages people to embrace their individuality. The Trust values difference and welcomes all applications irrespective of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex and sexual orientation. Providing they meet the minimum post criteria, applicants with disabilities will be offered an interview.

Date posted

18 August 2022

Pay scheme

Agenda for change

Band

Band 6

Salary

£33,706 to £40,588 a year

Contract

Permanent

Working pattern

Full-time, Flexible working

Reference number

C9175-2223-2-RD3451

Job locations

Royal Papworth Hospital

Papworth Road

Cambridge Biomedical Campus

Cambridge

Cambridgeshire

CB2 0AY

Job description

Job responsibilities

On this page you will find a Role Profile which provides information about the hospital and full details about the role. We recommend that you review this and refer to it as you complete your application. Please include how you will meet the Trust Values Compassion Excellence Collaboration. If you would like more information about the role or working at Royal Papworth Hospital, please get in touch with the contact for this role.

Job description

Job responsibilities

Person Specification

Knowledge

Essential

Good working knowledge of database technology, query building and report writing.
Sound knowledge of statistical software (e.g., R).
Extensive understanding and knowledge of improving and maintaining Data Quality.

Desirable

Good knowledge of GCP requirements and all aspects of information governance and related legislation for electronic data capture and data base validation.

Skills

Essential

Ability to quickly analyse and interpret data to diagnose issues in database design and /or data entry
Good understanding of overall database design, software implementation and related business processes
Demonstrable ability to learn to use new computing systems, packages and languages rapidly and accurately.
An accurate worker, able to work under pressure to tight deadlines. Methodical in approach, with effective problem-solving ability.
Good analysis skills and be able to work closely with the project teams to identify their reporting requirements.
Ability to communicate clearly to both technical and non-technical colleagues.
Willingness to maintain and update skills, including attendance of courses on and off site.
Proficient in the use of MS Office applications.

Qualifications

Essential

Professional Qualification in Information/ database management
or degree in a science / healthcare subject and some experience in data management
or extensive experience in data management

Experience

Essential

Experience in managing complex or large relational databases or EDCs
Experience using of SQL databases (e.g., PostgreSQL.)
Experience of programming / rule writing
Experience of running web servers and data servers.

Desirable

Experience working in a clinical trials setting or academic environment
Demonstrable experience working with health data
Expertise in using the OpenClinica (version 3) data management system
Expertise in using the OpenClinica (version 4) data management system

Values and Behaviours

Essential

Evidence ability to uphold the Trusts values Compassion Excellence Collaboration and associated behaviour standard at all times.

Other Criteria

Essential

Commitment to flexible working hours as this may be a requirement for specific meetings.
Attention to detail.

Person Specification

Knowledge

Essential

Good working knowledge of database technology, query building and report writing.
Sound knowledge of statistical software (e.g., R).
Extensive understanding and knowledge of improving and maintaining Data Quality.

Desirable

Good knowledge of GCP requirements and all aspects of information governance and related legislation for electronic data capture and data base validation.

Skills

Essential

Ability to quickly analyse and interpret data to diagnose issues in database design and /or data entry
Good understanding of overall database design, software implementation and related business processes
Demonstrable ability to learn to use new computing systems, packages and languages rapidly and accurately.
An accurate worker, able to work under pressure to tight deadlines. Methodical in approach, with effective problem-solving ability.
Good analysis skills and be able to work closely with the project teams to identify their reporting requirements.
Ability to communicate clearly to both technical and non-technical colleagues.
Willingness to maintain and update skills, including attendance of courses on and off site.
Proficient in the use of MS Office applications.

Qualifications

Essential

Professional Qualification in Information/ database management
or degree in a science / healthcare subject and some experience in data management
or extensive experience in data management

Experience

Essential

Experience in managing complex or large relational databases or EDCs
Experience using of SQL databases (e.g., PostgreSQL.)
Experience of programming / rule writing
Experience of running web servers and data servers.

Desirable

Experience working in a clinical trials setting or academic environment
Demonstrable experience working with health data
Expertise in using the OpenClinica (version 3) data management system
Expertise in using the OpenClinica (version 4) data management system

Values and Behaviours

Essential

Evidence ability to uphold the Trusts values Compassion Excellence Collaboration and associated behaviour standard at all times.

Other Criteria

Essential

Commitment to flexible working hours as this may be a requirement for specific meetings.
Attention to detail.

Employer details

Employer name

Royal Papworth Hospital NHS Foundation Trust

Address

Royal Papworth Hospital

Papworth Road

Cambridge Biomedical Campus

Cambridge

Cambridgeshire

CB2 0AY

Employer's website

https://royalpapworth.nhs.uk/working-here (Opens in a new tab)

Employer details

Employer name

Royal Papworth Hospital NHS Foundation Trust

Address

Royal Papworth Hospital

Papworth Road

Cambridge Biomedical Campus

Cambridge

Cambridgeshire

CB2 0AY

Employer's website

https://royalpapworth.nhs.uk/working-here (Opens in a new tab)