About this role
Job summary
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 & 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 & 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
Work alongside the Project Manager to work from EDC guidelines to ensure proformas are reflective of the data collection needed.
Ensure a consistent approach to local study documentation taking account of regulations and external requirements e.g. Trial Master Files.
Co-ordinate data collection: ensure timely submission of accrual data; review data for completeness and accuracy where appropriate, liaising closely with the study management team.
Monitor 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-ordinate the design, printing and distribution of trial documentation, and ensure all paperwork is of the appropriate standard.
Write policies and procedures relating to data where needed.
Provide a high standard of data entry within databases and study management systems, this includes working within a variety of web-based platforms.
Create and maintain the study Investigator Site files and oversight of site files, ensuring these are kept tidy and current by appropriate filing of documentation.
Maintain awareness of regulatory requirements, i.e. NHS Research Ethics Committee, UK Policy Framework for Health and Social Care Research (2017), ICH-GCP, GDPR, and advise others accordingly.
About us
The Adam Practice is an innovative, large 5 site practice, caring for approximately 40,000 patients. Our team of around 170 people includes many allied health professionals, including doctors, paramedics, nurses, healthcare assistants, support, and administration staff.
Due to our size, we value communication and teamwork. We operate a strongly relational team structure and endeavour to listen well, encourage ownership and involvement, and enable staff to grow in their individual development.
Job description Job responsibilities
The role of the Data Manager (DM) will be of one that will support all R&D functions & life cycle of clinical trials. The DM will take on responsibilities such as using electronic data capture (EDC) systems, producing proformas for data collection, completing data query resolution, be aware of timeline for data entry & query resolution. The DM will be using IT programmes such as excel/Microsoft 365, Investigator Site Files (ISFs) and e-ISFs such as Florence.
Person Specification
Qualities and Attributes Essential
Knowledge of research governance and regulations (ICH GCP & EU directives) Excellent communication & interpersonal skills. Ability to initiate, manage & 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 & as part of the team. Ability to organise, prioritise, co-ordinate own self & work Takes accountability for ones actions. Shares information & good practice appropriately. Treats others with courtesy & 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 & their application in practice. Knowledge of clinical governance.
Desirable
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 & their application in practice. Knowledge of clinical governance.
Qualifications Essential
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
Desirable
Experience in research management
Experience Essential
Experience of problem solving & the ability to work autonomously. Experience in using various EDC platforms. Experience in using IT programmes. Experience of working to tight deadlines and managing a range of priorities.
Desirable
Experience in SystmOne Experience in reviewing paperwork relating to research to extract information required for a specific purpose.
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.
Employer details Employer name The Adam Practice
Address The Adam Practice
Upton Cross Blandford Road North
Poole
Dorset
BH16 5PW
United Kingdom
Employer's website https://www.adampractice.co.uk/ (Opens in a new tab)