Job summary
Band 4 Data Manager 12 Month Secondment / fixed term
An exciting opportunity has arisen within R&D for a 12 month Band 4 Data Manager secondment.
The position is for 37.5 hours and will be based within the R&D Digital & Data Delivery team.
The role will include tasks such tracker development, access management, data analysis, technical support for in-house research designed systems and supporting the Digital Project Manager rolling out and maintaining research specific systems.
Please ensure that your current line manager supports your interest in this post if you would like to be considered for secondment opportunity
Closing Date: Please be advised that this job advert will close as soon as sufficient applications have been received. Please apply for this job as soon as you can, if interested.
Main duties of the job
The Data Manager is an integral member of the R&D Digital & Data team providing and supervising a high quality data management service to assist in the delivery of research trials in a safe and timely manner.
The post holder will be expected to take responsibility for the provision of data management across a number of teams for research studies with the maintenance of accurate and comprehensive records being an essential aspect of the role.
They will be a flexible, motivated team player who is able to develop a good understanding of clinical trials. They will take responsibility for supervising other members of the data management team ensuring the smooth running of the service providing efficient and effective administrative and organisational support to a number of teams as workload dictates.
The post holder will need to have a good level of written and verbal communication skills, excellent IT skills and be able to manage workload effectively with minimal supervision; in return they will be supported through a comprehensive training/competency package as appropriate to the job role.
The job holder may be required to carry out other similar or related duties which do not fall within the work outlined in the description which may reasonably be required to deliver a comprehensive research service to our patients. The Line Manager, in consultation with the post holder will undertake any review.
About us
University Hospitals Coventry and Warwickshire NHS Trust, rated as good by the Care Quality Commission, is one of the largest teaching Trusts in the UK.We are extremely proud of our employees across our hospital sites, with high quality patient care at the heart of everything we do.Boasting some of the most modern facilities in Western Europe, the Trust is renowned for being at the forefront of research and innovation as part of its blossoming reputation as a worldwide leader in healthcare.We are proud to be recognised as a Pathway to Excellence designated organisation - please click the link for further details about this prestigious award. Pathway To Excellence - University Hospitals Coventry & Warwickshire (uhcw.nhs.uk)By joining our exciting journey, you will form part of a passionate, talented team and will be able to access a wide range of learning and development opportunities. There has never been a better time to join our team.The Trust is committed to building an organisation that makes full use of the talents, skills, experience, and different perspectives available in our diverse society. We want everyone to feel they are respected, valued, can achieve their potential and receive the most appropriate and relevant care. We will create an environment where the equality and human rights principles of fairness, respect, equality, dignity and autonomy are promoted and are part of the organisation's core values.
Job description
Job responsibilities
Responsible for the data management of a specified number of clinical trials (as agreed with line manager) across differing specialities becoming familiar with the treatment regimes outlined in the clinical trial protocols.
Liaise with clinical trials offices, pharmaceutical company staff and other non-Trust staff to ensure the smooth running of clinical trial data collection.
Facilitate the secure storage of study documentation in accordance with ICH GCP and Research Governance.
Organise and maintain efficient filing systems.
Ensure appropriate clinical trial consent forms have been completed and are stored securely so that patients can be registered and / or randomised in clinical trials.
Collection of patient data from medical notes and completion of case report forms (CRFs). Checking all data is recorded accurately and in a timely manner.
Sending of completed CRFs either paper or electronic in a timely fashion to the relevant Clinical Trial Office.
Entry of data onto the departmental databases.
Collect diagnostic and treatment details and analyse medical results in order to document toxicity and response to treatment etc, as specified in the clinical trial protocol.
Report and record serious adverse events which occur whilst the patient is in the clinical trial to the relevant personnel and act as required according to GCP and local guidelines.
Maintain relevant A/E or SAE databases and provide follow up data as required.
Liaise with consultants research nurses to ensure accurate data.
Track patients to predict when the next data collection is required.
Work to International Conference on Harmonisation Good Clinical Practice (ICH/GCP) and Research Governance Standards.
For further details of the role please see the attached job description.
Job description
Job responsibilities
Responsible for the data management of a specified number of clinical trials (as agreed with line manager) across differing specialities becoming familiar with the treatment regimes outlined in the clinical trial protocols.
Liaise with clinical trials offices, pharmaceutical company staff and other non-Trust staff to ensure the smooth running of clinical trial data collection.
Facilitate the secure storage of study documentation in accordance with ICH GCP and Research Governance.
Organise and maintain efficient filing systems.
Ensure appropriate clinical trial consent forms have been completed and are stored securely so that patients can be registered and / or randomised in clinical trials.
Collection of patient data from medical notes and completion of case report forms (CRFs). Checking all data is recorded accurately and in a timely manner.
Sending of completed CRFs either paper or electronic in a timely fashion to the relevant Clinical Trial Office.
Entry of data onto the departmental databases.
Collect diagnostic and treatment details and analyse medical results in order to document toxicity and response to treatment etc, as specified in the clinical trial protocol.
Report and record serious adverse events which occur whilst the patient is in the clinical trial to the relevant personnel and act as required according to GCP and local guidelines.
Maintain relevant A/E or SAE databases and provide follow up data as required.
Liaise with consultants research nurses to ensure accurate data.
Track patients to predict when the next data collection is required.
Work to International Conference on Harmonisation Good Clinical Practice (ICH/GCP) and Research Governance Standards.
For further details of the role please see the attached job description.
Person Specification
Qualifications
Essential
Desirable
Experience
Essential
Desirable
Knowledge
Essential
Desirable
Skills
Essential
Person Specification
Qualifications
Essential
Desirable
Experience
Essential
Desirable
Knowledge
Essential
Desirable
Skills
Essential
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
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.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
