This is an exciting role for a DataManager 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 collaborationconsisting of 5 practices who have committed to work collaboratively & havedone for the past 2 years delivering commercial clinical trials to participantsacross the patch. The vision of the NIHR CRDC Dorset (PC) is to enablepractices across Dorset, who so wish to be research active, achieve thisthrough the ongoing support of the CRDC Dorset (PC). The Adam Practice hoststhe CRDC Dorset (PC) and will support R&D function including study set up& delivery. All the practices in theCRDC Dorset (PC) are partners and work as spokes delivering clinical trials forpatient benefit.
Main duties of the job
Workalongside the Project Manager to work from EDC guidelines to ensure proformasare reflective of the data collection needed.
Ensurea consistent approach to local study documentation taking account ofregulations and external requirements e.g. Trial Master Files.
Co-ordinate datacollection: ensure timely submission of accrual data; review data forcompleteness and accuracy where appropriate, liaising closely with the studymanagement team.
Monitortrial progress to ensure compliance with and adherence to the project plan andto identify, evaluate and help rectify problems alongside the Project Manager.
Co-ordinate thedesign, printing and distribution of trial documentation, and ensure allpaperwork is of the appropriate standard.
Writepolicies and procedures relating to data where needed.
Providea high standard of data entry within databases and study management systems,this includes working within a variety of web-based platforms.
Createand maintain the study Investigator Site files and oversight of site files,ensuring these are kept tidy and current by appropriate filing ofdocumentation.
Maintainawareness of regulatory requirements, i.e. NHS Research Ethics Committee, UKPolicy Framework for Health and Social Care Research (2017), ICH-GCP, GDPR, andadvise others accordingly.
Job responsibilities
The role of the Data Manager (DM)will be of one that will support all R&D functions & life cycle ofclinical trials. The DM will take on responsibilities such as using electronicdata capture (EDC) systems, producing proformas for data collection, completingdata query resolution, be aware of timeline for data entry & queryresolution. 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
* 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.
* 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
* 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 & 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.
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.
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