NIHR Dorset PC CRDC Data Manger

This is an exciting role for a Data Manager to be part of a new network of Commercial Research Delivery Centre (CRDC) in Primary Care (PC) to deliver clinical trials across Dorset within the NIHR CRDC Dorset (PC). Our NIHR CRDC Dorset (PC) is a solid collaboration consisting of 5 practices who have committed to work collaboratively and have done for the past 2 years delivering commercial clinical trials to participants across the patch. The vision of the NIHR CRDC Dorset (PC) is to enable practices across Dorset, who so wish to be research active, achieve this through the ongoing support of the CRDC Dorset (PC). The Adam Practice hosts the CRDC Dorset (PC) and will support R&D function including study set up and delivery. All the practices in the CRDC Dorset (PC) are partners and work as spokes delivering clinical trials for patient benefit.

Main duties of the job include:

• Working alongside the Project Manager to ensure proformas are reflective of the data collection needed.
• Ensuring a consistent approach to local study documentation taking account of regulations and external requirements e.g. Trial Master Files.
• Co-ordinating data collection: ensuring timely submission of accrual data; reviewing data for completeness and accuracy where appropriate, liaising closely with the study management team.
• Monitoring trial progress to ensure compliance with and adherence to the project plan and to identify, evaluate and help rectify problems alongside the Project Manager.
• Co-ordinating the design, printing and distribution of trial documentation, and ensuring all paperwork is of the appropriate standard.
• Writing policies and procedures relating to data where needed.
• Providing a high standard of data entry within databases and study management systems, including working within a variety of web-based platforms.
• Creating and maintaining the study Investigator Site files and oversight of site files, ensuring these are kept tidy and current by appropriate filing of documentation.
• Maintaining awareness of regulatory requirements, i.e. NHS Research Ethics Committee, UK Policy Framework for Health and Social Care Research (2017), ICH-GCP, GDPR, and advising others accordingly.

The role of the Data Manager (DM) will support all R&D functions and life cycle of clinical trials. Responsibilities include using electronic data capture (EDC) systems, producing proformas for data collection, completing data query resolution, and being aware of timelines for data entry and query resolution. The DM will use IT programmes such as Excel/Microsoft 365, Investigator Site Files (ISFs) and e-ISFs such as Florence.

Person Specification:

• Knowledge of research governance and regulations (ICH GCP & EU directives).
• Excellent communication and interpersonal skills.
• Ability to initiate, manage and sustain change.
• Ability to prioritise tasks and manage time effectively, coping with deadlines.
• Able to delegate effectively, understanding the strengths and weaknesses of team members to build effective teamwork.
• Good attendance at work.
• A flexible approach to work.
• Effective time management.
• Ability to work independently and as part of the team.
• Ability to organise, prioritise, co-ordinate own self and work.
• Takes accountability for one's actions.
• Shares information and good practice appropriately.
• Treats others with courtesy and respect at all times.
• Working knowledge of the UK clinical trials regulations, Data Protection Act (1988), Mental Capacity Act, Human Tissue Act, ICH-GCP, Research Governance and ethical Frameworks.
• Knowledge of clinical trials protocols and their application in practice.
• Knowledge of clinical governance.

Qualifications:

• Educated to degree level in life sciences OR relevant experience.
• ICH-GCP R3 training.
• A willingness to undergo personal development and training and learn new skills.
• Experience in research management.

Experience:

• Experience of problem solving and the ability to work autonomously.
• Experience in using IT programmes.
• Experience of working to tight deadlines and managing a range of priorities.
• Experience in SystmOne.
• Experience in reviewing paperwork relating to research to extract information required for a specific purpose.

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 to check for any previous criminal convictions.