Job summary
This is an exciting role for a Data
Manager to be part of a new network of Primary Care Clinical Research Delivery
Centres (PC-CRDC) to deliver clinical trials across Dorset. Within the PC-CRDC
the Dorset Primary Care Clinical Research Group (DPCCRG) are 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 PC-CRDC is
to enable practices across Dorset, who so wish to be research active, achieve
this through the ongoing support of the PC-CRDC. The Adam Practice hosts the
PC-CRDC and will support R&D function including study set up &
delivery. All the practices in the
PC-CRDC are partners and work as spokes delivering clinical trials for patient
benefit.
Main duties of the job
-
Develop effective working relationships with the
site Principal Investigators, Sponsor team and other study staff to ensure
appropriate support is in place to conduct research safely, efficiently and
effectively
-
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
-
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
About us
The Adam Practice is a partnership located across 5 surgeries in Poole, Dorset. This is an exciting opportunity to join our growing primary care team in a forward- thinking, innovative, general practice, which has a current CQC rating ofOutstanding in Care.
Here are some of our many benefits we offer;
Access to NHS Pension Scheme and NHS discounts, 5 weeks annual leave (inclusive of bank/public holidays that fall in the holiday year). Entitlement is pro-rata for part-time employees.
Auto enrolment in NHS Pension Scheme.
Cycle to work scheme.
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.
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
Experience
Essential
- Experience of problem solving & the ability to work autonomously.
- Experience of using IT programmes.
- Experience of working to tight deadlines and managing a range of priorities.
Desirable
- Experience in SystmOne
- Experience in using EDC full training will be given if no experience
- Experience in reviewing paperwork relating to research to extract information required for a specific purpose.
Qualifications
Essential
- Educated to degree level in life sciences OR relevant experience
- ICH-GCP training
- A willingness to undergo personal development and training and learn new skills
Desirable
- Experience in research management
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.
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.
Person Specification
Experience
Essential
- Experience of problem solving & the ability to work autonomously.
- Experience of using IT programmes.
- Experience of working to tight deadlines and managing a range of priorities.
Desirable
- Experience in SystmOne
- Experience in using EDC full training will be given if no experience
- Experience in reviewing paperwork relating to research to extract information required for a specific purpose.
Qualifications
Essential
- Educated to degree level in life sciences OR relevant experience
- ICH-GCP training
- A willingness to undergo personal development and training and learn new skills
Desirable
- Experience in research management
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.
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.
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.
