Job summary
The Department of Oncology would like to recruit a Clinical Trials Data Manager who will provide data management support for both commercial and non-commercially funded cancer clinical trials undertaken by the Early Phase Clinical Trials Team (EPCTT) within the Cambridge Cancer Trials Centre (CCTC).
Early Phase clinical trials, led by Professor Duncan Jodrell, are a major element of the research undertaken by the Cambridge Cancer Centre. The EPCTT's research goals are to optimise the "science-led" clinical application of novel therapies for cancer, including "first into man" (Phase I) and associated studies.
The role includes assisting in the registration and randomisation of patients onto clinical trials, according to the trial protocol requirements; ensuring that protocol required tests/procedures are carried out according to the schedule in the specific protocol and in compliance with GCP guidelines and completion of trial documentation.
The funding supporting this position is available for 12 months in the first instance.
Main duties of the job
To assist an experienced multi-disciplinary team running clinical trials, with specific responsibility in the management of the day to day collection of data. You will be responsible for the submission of data for trials using a variety of data capture tools. You will use effective communication with external agencies and internal teams to ensure the accuracy and completeness of data submitted.
About us
Our Trust
Cambridge University Hospitals (CUH) NHS Foundation Trust comprises Addenbrooke's Hospital and the Rosie Hospital in Cambridge. With over 11000 staff and over 1100 beds the priorities of the Trust focus on a quality service which is all about people - patients, staff and partners. Recognised as providing 'outstanding' care to our patients and rated 'Good' overall by the Care Quality Commissioner, is testament to the skill and dedication of the people who work here. CUH's values - Together - Safe, Kind, Excellent - are at the heart of patient care, defining the way all staff work and behave. The Trust provides accessible high-quality healthcare for the local people of Cambridge, together with specialist services, dealing with rare or complex conditions for a regional, national and international population.
CUH is committed to promoting a diverse and inclusive community - a place where we can all be ourselves. We value our differences and fully advocate and support an inclusive working environment where every individual can fulfil their potential. We want to ensure our people are truly representative of all the communities that we serve. We welcome applications for all positions in the organisation irrespective of people's age, disability, ethnicity, race, nationality, gender identity, sex, sexual orientation, religion or belief, marriage and civil partnership status, or pregnancy and maternity status or social economic background.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 1st October 2023.
Interviews are tentatively planned for 13th October 2023 - to be confirmed.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
We welcome applications from the Armed Forces.
Job description
Job responsibilities
Please see the attached Applicant Information Pack (combined Job Description and Person Specification) for key duties and responsibilities.
This vacancy will close at midnight on the 1st October 2023.
Interviews are tentatively planned for 13th October 2023 - to be confirmed.
Benefits to you
We offer development opportunities and a wide range of benefits including on-site leisure facilities, shopping concourse, day nurseries and access to a great transport system with easy access to airports and rail travel.
Please note if you would like to discuss the required hours of this role further, you should approach the contact given. In some cases alternative working hours will be considered.
We welcome applications from the Armed Forces.
Person Specification
Qualifications
Essential
- Educated to degree level or NVQ level 4 or equivalent in a biological, physical, social or related scientific discipline OR Equivalent experience in oncology clinical trials data management.
Desirable
- Evidence of continuing professional development in research.
Experience
Essential
- Worked in the NHS or other similar biological / scientific discipline.
- Research Data Collection experience within an NHS/ biological / scientific discipline.
- Experience of liaison with staff across all levels within the NHS/Universities/Industry.
- Experience of dealing with difficult situations and confrontations.
- Experience of working autonomously within guidelines and deadlines.
- Experience of prioritising, planning and organising own tasks.
- Experience of liaison with external agencies.
- Experience of using patient management tools for research.
Desirable
- Experience of working in Cancer.
- Experience of audit.
- Familiarity with EPIC.
- Participation at Site Initiation Visits.
- Experience with using databases.
- Experience in producing and presenting reports.
- Experience of mentoring, facilitating or training.
- Experience of using schedules of assessments within research protocols to determine trial participant requirements.
Knowledge
Essential
- Sound understanding of ethical and quality standards applicable to clinical trials, including EU Directive, ICH GCP.
- GCP Trained.
- Confidentiality and data protection processes and procedures.
- Understanding of research patient management tools.
- Knowledge of medical terminology.
Skills
Essential
- Well-developed organisational and communication skills.
- Computer Literate and proficiency(including MS Word, Excel, PowerPoint, Access).
- Skills for nurturing key relationships with external agencies.
- Meticulous attention to detail with a high standard of accuracy.
- Attention to detail and high standard of accuracy.
- Ability to adapt to change.
- Ability to work under pressure.
- Ability to train and mentor less experienced colleagues.
- Ability to present data in clear & simple format.
- Skills in handling and management of computerised data.
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of Together - Safe, Kind, Excellent.
- Ability to work effectively in multi-disciplinary team.
- Able to prioritise work using own initiative.
- Highly professional approach to work, in particular in dealing with confidential information.
Person Specification
Qualifications
Essential
- Educated to degree level or NVQ level 4 or equivalent in a biological, physical, social or related scientific discipline OR Equivalent experience in oncology clinical trials data management.
Desirable
- Evidence of continuing professional development in research.
Experience
Essential
- Worked in the NHS or other similar biological / scientific discipline.
- Research Data Collection experience within an NHS/ biological / scientific discipline.
- Experience of liaison with staff across all levels within the NHS/Universities/Industry.
- Experience of dealing with difficult situations and confrontations.
- Experience of working autonomously within guidelines and deadlines.
- Experience of prioritising, planning and organising own tasks.
- Experience of liaison with external agencies.
- Experience of using patient management tools for research.
Desirable
- Experience of working in Cancer.
- Experience of audit.
- Familiarity with EPIC.
- Participation at Site Initiation Visits.
- Experience with using databases.
- Experience in producing and presenting reports.
- Experience of mentoring, facilitating or training.
- Experience of using schedules of assessments within research protocols to determine trial participant requirements.
Knowledge
Essential
- Sound understanding of ethical and quality standards applicable to clinical trials, including EU Directive, ICH GCP.
- GCP Trained.
- Confidentiality and data protection processes and procedures.
- Understanding of research patient management tools.
- Knowledge of medical terminology.
Skills
Essential
- Well-developed organisational and communication skills.
- Computer Literate and proficiency(including MS Word, Excel, PowerPoint, Access).
- Skills for nurturing key relationships with external agencies.
- Meticulous attention to detail with a high standard of accuracy.
- Attention to detail and high standard of accuracy.
- Ability to adapt to change.
- Ability to work under pressure.
- Ability to train and mentor less experienced colleagues.
- Ability to present data in clear & simple format.
- Skills in handling and management of computerised data.
Additional Requirements
Essential
- The ability to understand and behave at all times, towards patients, visitors and colleagues according to the Trust values of Together - Safe, Kind, Excellent.
- Ability to work effectively in multi-disciplinary team.
- Able to prioritise work using own initiative.
- Highly professional approach to work, in particular in dealing with confidential 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).
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).
Employer details
Employer name
Cambridge University Hospital NHS Foundation Trust
Address
Addenbrookes Hospital - Division R&D
Hills Road
Cambridge
CB2 0QQ
Employer's website
https://www.cuh.nhs.uk (Opens in a new tab)