Clinical Trials Data Manager

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Detailed job description and main responsibilities

The specific responsibilities will depend on the requirements of each team, but may include:
• Act as a point of contact for the core Research and Development team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant general trial conduct.
• Timely set up and initiation of source data workbooks within an assigned team, under the guidance of the Senior Clinical Trials Data Coordinators for review by the lead Research Nurse and ensure version control is maintained.
• Track all payments throughout each clinical trial including completion of activity logs ensuring that all research activity is recorded to facilitate full cost recovery.
• Assist with the maintenance of the investigator site files and essential documentation (filing consent forms and enrolment forms and completing patient logs) in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times.
• Responsible for keeping trial folders, including blood results and laboratory requisition forms up to date in accordance with the study's standard operating procedure.
• Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costings spreadsheets, CRF trackers, electronic proformas, serious adverse events trackers, data entry metrics trackers and workbook trackers).
• Ensure collection and tracking of clinical case notes for all patients, so that these are available as needed, for monitoring and audit purposes.
• Ensure that data collected for all trials meets protocol requirements and is complete and accurate.
• To check the validity and completeness of research data collected within the Trust and take action to obtain or correct missing or contradictory data.
• Complete case report forms as per sponsor requirements to meet data entry deadlines stipulated in the clinical trial protocol and/or contract.
• Liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met at site monitoring visits.
• To resolve queries by initiating correspondence or direct contact with the research nurses/clinicians and other relevant health care professionals ensuring that reporting timelines are met.
• Support the clinical research nurses to ensure that reports of serious adverse events are returned to co-ordinating centres/sponsors within the standard time frame.
• To advise senior members of the team as appropriate, of any concerns relating to protocol adherence, data quality, handling of confidential data or meeting timelines.
• Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper sources.
• Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in nature.
• To ensure confidentiality and security of patients data at all times, particularly when transferring data outside of the Trust.
• Arrange shipping and delivery of relevant trial data and documents including import/export of anonymised data.
• Arrange team and trial related meetings as required, producing minutes in a timely manner.
• Ensure that data is available and up to date for any meetings related to a clinical trial.
• If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) and Site Initiation Visits to convey the relevant information to the study team.
• Assist with preparation for audit and inspections within assigned teams.
• Assist Clinical Trial Coordinators with trial document archiving by following the Trust's archiving guidelines.
• Undertake general administrative tasks as delegated by managerial representatives from the Research Division ton contribute to the smooth running of the patient recruitment teams.

Person specification

Qualifications

Essential criteria

• Diploma or administration experience.

Desirable criteria

• Degree in a science or health related discipline.
• Relevant training courses in clinical research.
• Relevant research experience.
• Relevant IT experience/Qualification in computing or IT (i.e. ECDL qualification)

Experience

Essential criteria

• Experience in administration.

Desirable criteria

• Experience in clinical trial administration including data management.
• Experience of working within a health care system.
• Relevant experience within a Good Clinical Practice and research environment.

Skills

Essential criteria

• Good organisational skills.
• Flexible.
• Good interpersonal skills.
• Tactful and diplomatic.
• Good oral and written communication skills.
• Excellent time management skills with an ability to prioritise.
• Good IT skills.
• Attention to detail.

Desirable criteria

• Good understanding and demonstrate use of the Microsoft Office suite.
• Understanding of case report forms.

Knowledge

Essential criteria

• Knowledge of the clinical trials process.
• Awareness of GCP guidelines/EU directives.

Desirable criteria

• Understanding of medical terminology and cancer.
• Knowledge of clinical governance.
• Knowledge of patient information systems.

Values

Essential criteria

• Ability to demonstrate the organisational values and behaviours of The Christie NHS Foundation Trust.

Other

Essential criteria

• Ability to work unsupervised or as part of a team.

The closing date for this post may be extended if there are insufficient applicants or brought forward if there is a high volume of applicants.

We want to ensure that everyone who works at the Christie or uses our services is welcomed, valued and treated with dignity and respect. The Christie values diversity and is committed to ensuring equal opportunities for all and fair representation across the organisation at all levels. In support of these commitments, we particularly welcome applications from Black, Asian and other ethnic minority people and people with disabilities for this post. Appointment will be only on merit.

We are committed to creating a balanced and diverse workforce. As such we welcome and encourage applications from people of all backgrounds. Together we will foster inclusion and tackle inequity and health inequalities in cancer care.

As users of the disability confident scheme, we guarantee to interview all disabled applicants who meet the minimum criteria for the vacancy

All positions within the Christie are subject to the receipt of satisfactory written references, medical clearance and evidence of your Right to Work in the UK. Some roles will require a Disclosure & Barring Service (DBS) check. Please note if you are successfully appointed to a post with this Trust, you will be required to pay for your own DBS Disclosure.

By applying for this post you are agreeing to The Christie NHS Foundation Trust transferring the information contained in this application to its preferred applicant management system. If you are offered a job information will also be transferred into the national NHS Electronic Staff Records system. Please note, all communication regarding your application will be made via email, please ensure you check your junk/spam folders as emails are sometimes filtered there.

If you have not heard from us within four weeks of the closing date, I regret that on this occasion your application will have been unsuccessful.

The Inter-Authority Transfer (IAT) process is a critical and beneficial component of ESR and will form part of the recruitment process. In the event that you are successful following interview your previous NHS employment data, if applicable will be transferred from your current / most recent employer.

Overseas candidates wishing to apply for this position and who would require immigration sponsorship, may wish to self-assess the likelihood of obtaining a Certificate of Sponsorship for the post on the UKVI website.

You should be aware the Trust operates a No Smoking Policy and therefore employees are not permitted to smoke at work.

Employer certification / accreditation badges

Documents to download

• Job Description and Person Specification (PDF, 238.3KB)
• The Christie Values and Behaviours (PDF, 919.5KB)
• Strategy Brochure (PDF, 1.0MB)
• Travel to The Christie (PDF, 3.8MB)