Senior Early Phase & Cell therapy Data Manager

Job overview

The post holder will be working within the Early Phase & Cell Therapy  Oncology research team to ensure high quality data management in adherence to GCP, MHRA regulations, and institutional SOPs. This role involves working closely with clinical teams, researchers, and IT personnel to facilitate accurate data collection, secure data handling, and efficient trial management. The post holder will be responsible for maintaining Investigator Site Files, managing trial documentation, verifying source data, and preparing for audits and monitoring visits. They will lead departmental data management training, contribute to SOP development, and support continuous improvement initiatives.

Main duties of the job

• Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the patient’s medical notes and trial file is transcribed accurately.
• Liaise with the clinical team to organise and ensure that trial specific investigations are undertaken according to the protocol and obtain the results.
• Ensure the confidentiality of verbal, written and computerised information.
• Work in accordance with and ensure trials are managed to all regulatory requirements
• Lead on data management training for the department
• Supervise Junior Staff and data managers as required

Detailed job description and main responsibilities

Duties and Responsibilities

Clinical research

• Liaise with the clinical team to organise and ensure that trial specific investigations are undertaken according to the protocol and obtain the results.
• Ensure the confidentiality of verbal, written and computerised information.
• Work in accordance with and ensure trials are managed to all regulatory requirements including:•    local Standard Operating Procedures (SOPs)•    Good Clinical Practice (GCP)•    European Directives•    Medicines for Human Use (Clinical Trials) Regulations•    Research Governance Framework for Health and Social Care•    Human Tissue Act.

Organisational

• Complete case report forms in a precise and timely manner, ensuring that all the relevant clinical data in the patient’s medical notes and trial file is transcribed accurately.
• Create and maintain the file of current protocols and patient information sheets. Be responsible for the maintenance of the Investigator Site Files paying particular attention to accurate data collection and transfer and version control of essential documentation.
• Assist in the creation and maintenance of good office systems for the smooth running of the service.
• Process amendments according to standard operating procedure as received in a timely manner
• Conduct source data verification and quality control activities as part of the in-house quality monitoring programme  the Theme.
• Working with the imaging coordinator to transfer and upload images into relevant vendor systems
• Deal with data queries in a timely and efficient manner.
• Plan, prepare and participate documentation for audit and monitoring visits.
• Arrange, attend and record minutes for research and other relevant departmental meeting.
• Actively seek to develop the role to take account of changing requirements of the service.

Education and Training

• Lead on data management training for the department
• Take responsibility for Data management training identifying personal training and educational needs within the context of the service and those identified during the appraisal process.
• Attend national and international Investigator Meetings and conferences as required.
• To work with the Quality Manager in updating, developing and implementing Standard Operating Procedures (SOPs).

Communication

• The post holder will provide advice and training on data management within the OHCT.
• Exchange often complex information with data suppliers, researchers and the IT team.
• Escalation of any issues regarding data collection to the appropriate personnel, both within the OHCT and in partner organisations.

Information management

• The post holder will create databases, validate and maintain them and ensure their security and compliance with the data protection act.
• Accurately and efficiently enter patient data on to current databases. This will require a high level of attention to detail and accuracy.
• Create and manipulate reports from the current databases to provide researchers with user friendly information.
• Ensure appropriate confidentiality of records and information (verbal, written and computerised).
• Extract information from patient medical records and transcribe these onto data collection tools in a confidential manner
• Be able to deal effectively with queries relating to data and information within

Other

• Work closely with colleagues in the OHCT in order to support the effective collection and storage of data.
• The post holder will be expected to support audit and survey work on behalf of the department.
• Work under own initiative seeking advice from the centre manager when necessary.
• Supervise Junior Staff and data managers as required

This job description in not intended to be exhaustive and is provided to assist you in the performance of your contract. Changes may be required from time to time in response to service requirements. These will be discussed with you as part of the Individual Personal Review process.