Clinical Trial Data Manager

Royal Papworth Hospital NHS Foundation Trust

This job is now closed

Job summary

About us: Papworth's Trials Unit Collaboration (PTUC) and is based in the Heart and Lung Research Institute, beside Royal Papworth Hospital on the Cambridge Biomedical Campus. The Data Management (DM) team works within PTUC to generate high quality data for our trials.

About the role: This role is integral to the DM team, and it is an excellent opportunity to utilise your clinical trial data management skills in all study types, including CTIMPs, devices and multi-centre studies. Being involved at all trial stages, from protocol design to database lock, giving ownership to the data.

The post holder 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.

They 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 DM team, to improve data analysis.

About you: You will have significant data management experience, within a clinical trial setting. You will have experience of using clinical data management systems and designing electronic case report forms and data validations. Previous line management experience would be beneficial.

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 UK's 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. We perform the most heart and/or lung transplants in the UK and carried out the UK's 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 & collaboration at its core, and all colleagues joining the team are expected to uphold these in their day-to-day roles & 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 & maternity, race, religion & belief, sex and sexual orientation. Providing they meet the minimum post criteria, applicants with disabilities will be offered an interview.

For a street view tour: https://royalpapworth.nhs.uk/virtual-tour

Date posted

15 November 2023

Pay scheme

Agenda for change

Band

Band 6

Salary

£35,392 to £42,618 a year

Contract

Permanent

Working pattern

Full-time, Part-time, Flexible working

Reference number

175-2324-2-RD315

Job locations

Heart and Lung Research Institute

Papworth Road

Cambridge Bio Medical Campus

Cambridge

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 and 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

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 EDC's for clinical trials.
Experience using of SQL databases (e.g., PostgreSQL.)
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.

Desirable

Expertise in using OpenClinica (OC3 or OC4)
Good knowledge of GCP requirements and all aspects of information governance and related legislation for electronic data capture and database validation.

Additional Criteria

Essential

Please provide evidence of your commitment to uphold the Trust's values: Compassion, Excellence, Collaboration

Person Specification

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 EDC's for clinical trials.
Experience using of SQL databases (e.g., PostgreSQL.)
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.

Desirable

Expertise in using OpenClinica (OC3 or OC4)
Good knowledge of GCP requirements and all aspects of information governance and related legislation for electronic data capture and database validation.

Additional Criteria

Essential

Please provide evidence of your commitment to uphold the Trust's values: Compassion, Excellence, Collaboration

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.