Data Manager - Cancer Research (UK) Clinical Trials Unit - 59292 - Band 400

Position Details

Cancer Research (UK) Clinical Trials Unit, Institute of Cancer and Genomic Sciences

Location: University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is normally in the range £20,488 to £21,868, with potential progression once in post to £26,603 a year.

Band 400

Full Time / Fixed Term Contract for 12 months

Closing date 11 May 2021

Job Summary

Data Managers are responsible for the clinical research data set for one or more cancer clinical trial(s) protocols which are designed to improve the treatment and care of patients with cancer. Principal duties include obtaining, entering and cleaning data from participating sites. In addition Data Managers provide administrative support to the multi-disciplinary collaborative research group(s) engaged in conducting trials.

Main Duties / Responsibilities

• Be a fully trained member of the units' randomisation team and take part in the regular 9-5 cover rota.
• A key communications point for the research team and members of the collaborating group, answers initial enquiries and generally follows through to resolution. Handles routine communications with the clinical investigators, research support staff and others in external centres for data collection. Must keep confidentiality and represent the unit well at all times.
• Ensure the smooth day-to day running of the study protocol and the data collection.
• Record and code incoming forms etc., checking for inconsistencies, violations and unusual or adverse events. May be required to abstract or verify data from source medical records, possibly involving visits to centres. Maintain and apply coding lists under the guidance of the Statistician, Trial Coordinator and Programmer.
• Enter routine data into the various research & administrative databases. Enter non-routine or ad-hoc data (i.e. that requires more interpretation or development of new codes) under guidance.
• Perform regular, systematic checks to validate and verify information on the data base(s) in order to produce a clean, accurate and complete data set for analysis. Identify and resolve any missing, incomplete or contradictory data. This typically involves sending standard letters or telephoning to outline the problem. Produce reports and lists on both a regular and ad-hoc basis.
• Work with Programmer, Statistician and Trial Coordinator to test data entry, validation and report generation applications (i.e. confirming proper functioning of the trial database systems), reporting errors and suggesting modifications if appropriate. May create and test simple ad-hoc data bases, forms and report generation.
• Provide secretarial support as required by the research team. Maintain stocks of supplies (both internally and at outlying centres) tracking on current version numbers. Assist in the organisation of collaborative group meetings and travel arrangements. May handle petty cash. Responsible for the day to day distribution of trial materials, and drug supplies required by external centres
• Develop and document standard operating procedures for the work of the post, under the guidance of the Trial Coordinator. Help supervise and train junior team members, and check the work done by others.
• Continue to develop and expand trial management skills and experience. Ongoing formal and on the job training to develop advanced computing and broader trial management skills.
• Will help to cover for the Trial Coordinator/project leader within own areas of expertise or projects. Other duties appropriate to the band may be assigned to the post.
• Other duties appropriate to the band may be assigned to the post.
• Support the delivery of clinical research in accordance with the principles of Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation (including, but not limited to, the Medicines for Human Use Clinical Trials Regulations, General Data Protection Regulations, Human Tissue Act), the UK Policy Framework for Health and Social Care, Caldicott principals, and applicable NHS Trust and University policies and procedures, (including, but not limited to the University's Data Protection Policy, Information Security Policy and Code of Practice for Research) in order to protect the research participants and the quality of each study.
• Supports equality and values diversity, moderates own behaviour to avoid unfair discriminatory impact or bias on others.

Person Specification

• Educated to at least 'A' level, or other equivalent formal vocational qualification (e.g. HND or NVQ 4), or relevant work experience ideally gained in a medical or academic setting.
• Experience of medical data coding, data entry and data validation techniques. Able to query and maintain computer databases (including Microsoft Access).
• Strong all-round office management experience and possess secretarial skills that must include up-to date computing and office automation skills (e.g. email, excellent word processing, good document layout etc).
• Must demonstrate a critical and intelligent attention to detail including high standards of accuracy.
• Good written/ verbal communication and an excellent telephone manner.
• A flexible and willing attitude to being part of a multidisciplinary team. Works well independently, with access to advice in deciding own short-term priorities and timetabling of tasks to meet agreed deadlines.
• Aptitude for learning and applying new skills, and once trained have the ability to work independently to gather information or simply finding missing or inaccurate data.
• A data manager should develop an understanding of the general underlying concepts of trial design, conduct and analysis.
• Data Managers are expected to develop an understanding of and have the ability to follow complex data management and administration procedures including the operation and maintenance of complex computer database and information systems.
• Ability to identify and break down potential problems using past experience and knowledge of good research practices. Work to develop and improve working procedures with coaching from colleagues and supervision from the Trial Coordinator e.g. to ensure consistent interpretation and coding of the data.
• Understands the importance of equality and diversity in the workplace
• Ability to identify and respond to equality and diversity issues in line with relevant policies and procedures

Informal enquiries can be made to Claire Gaunt ( C.H.Gaunt@bham.ac.uk )

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We value diversity at The University of Birmingham and welcome applications from all sections of the community