Job summary
This post is not open to overseas candidates due to salary requirements.

20 Hours per week to be decided with a view to increase over time.

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

• 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.
• 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.
• Support the coordination and preparation of documentation required for regulatory monitoring and auditing.
• 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 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 of Outstanding 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.

Person Specification
Essential Experience

• Experience of problem solving and 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

• Experience in SystmOne
• Experience in reviewing paperwork relating to research to extract information required for a specific purpose.

Essential 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

Desirable Qualifications

• Experience in research management

Essential Qualities and Attributes

• Knowledge of research governance and regulations (ICH GCP and 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 ones actions.
• Shares information and good practice appropriately.
• Treats others with courtesy and respect at all times.

Desirable Qualities and Attributes

• 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.

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: Upton Cross, Blandford Road North, Poole, Dorset, BH16 5PW, United Kingdom
Contact: tap.hr@dorsetgp.nhs.uk

Apply through our website.