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Trial Manager

Requisition ID:  13681
Location: 

Newcastle, GB

Contract Type:  Open Ended
Working Pattern:  Full Time
Posted Date:  23-Jun-2022

 

We are a world class research-intensive university. We deliver teaching and learning of the highest quality. We play a leading role in economic, social and cultural development of the North East of England. Attracting and retaining high-calibre people is fundamental to our continued success.

 

We understand how important the full employment package is to our colleagues at Newcastle University and we are committed to providing a great range of benefits and discounts for all.  You can learn more about what is available here on our Benefits Website page.

 

Salary: £31,406 - £33,309, rising to £40,927 per annum

 

Closing Date: 17 July 2022

 

The Role

Do you have a passion to support and drive benefits to healthcare through innovation?  


Newcastle Clinical Trials Unit is a thriving registered academic unit, working in collaboration with investigators to design and deliver clinical trials answering important clinical questions, whose findings bring substantial impact to patients and the NHS.  We are delighted to share with you an exciting opportunity for Trial Managers within our successful and expanding UKCRC Registered Clinical Trials Unit.  


This is a multi-faceted post requiring you to set-up, manage, co-ordinate and support clinical trials to ensure that they are conducted in line with sponsor, regulatory and research governance requirements. You will work as part of a multidisciplinary team including Senior Trial Managers, Clinical Trial Administrators, Statisticians, Data Managers, Chief Investigators and members of Trial Management Groups and other stakeholders to ensure successful completion of trials.


We currently have approximately 50 active trials, and work with multiple trial sponsors locally, nationally and internationally from two hubs in Newcastle (main hub) and South Tees. Chief Investigators, Principal Investigators and Co-Investigators are located throughout and beyond the University. You may be expected to work at both sites depending on the needs of individual trials and NCTU; we operate a blended approach to home and office working in line with University Guidance. It is likely that you will be working on a portfolio of between 2 and 3 trials at any one time, though this will vary. The trials will be of varying types of intervention and may be single or multi-centre. Newcastle Clinical Trials Unit is committed to the ongoing training and development of all staff. Opportunities include a range of internal and external courses in clinical trials and information governance, as well as opportunities for development and input through our UKCRC Registration, The UK Trial Manager Network and Trial Forge. 


Requests for part time working will be considered, and this post could be available to existing University colleagues as a secondment.  You should discuss this with your current manager before submitting your application.  

 

Further information about the NCTU can be found via the following link:  http://www.ncl.ac.uk/nctu/about/  

 

Please upload a CV and letter of application that states how you meet the essential criteria outlined in the person specification, using examples where possible.


Informal enquiries can be made to Chrissie Butcher (chrissie.butcher@ncl.ac.uk) and Michelle Bardgett (michelle.bardgett@ncl.ac.uk).
 

Key Accountabilities

•    Working as part of a trial team, provide day to day management of non-commercial clinical trials undertaken by Newcastle Clinical Trials Unit
•    Provide advice to investigators and trial staff to ensure compliance with legislative frameworks
•    Demonstrate in-depth knowledge of individual trials, alongside knowledge of the relevant therapeutic area
•    Work with all members of the trial team (including the Chief Investigator, Senior Trial Manager, Data Manager and Statistician) to ensure all processes throughout the trial lifecycle are completed within agreed trial time-lines, and any subsequently agreed plans
•    Work with the Data Management team to ensure that data cleaning procedures and quality controls produce trial data which is accurate, complete and timely
•    Proactively identify any issues within individual trials, appropriately escalating these, including to Senior Trial Managers, finding and implementing solutions as required (including:  recruitment; protocol deviations; serious breaches)
•    Set-up clinical trials, undertaken by NCTU, including contributing to the development of the trial protocol and other trial documentation, required for compliance with legislative frameworks
•    Complete and manage applications for Clinical Trial Authorisation, Ethical Opinion, HRA approval and other approvals as required
•    Ensure studies are conducted in accordance with GCP and other applicable legislation for Clinical Trials, and the General Data Protection Regulation
•    Work with the grants and contracts team, Sponsor, Senior Trial Manager and others, as appropriate, to ensure that contracts and agreements are in place for individual trials
•    Conduct site initiations and train site personnel in trial protocols and procedures during the trial
•    Performing monitoring of clinical trial sites, including measuring adherence to the protocol and standard operating procedures and applicable regulatory requirements
•    Close the trial, including completion of applicable regulatory reporting requirements and contribute to the funder report and wider dissemination of trial findings
•    Work as part of the Trial Management team and with others in NCTU (including QA) to ensure common ways of working and best practice in clinical trial management
•    Inform the development and implement the Unit’s Standard Operating Procedures (SOP’s) and develop trial-specific SOP’s
•    Prepare routine progress reports and ad hoc reports to funding bodies, sponsors, regulatory authorities, research ethics committees, Trust R&D departments etc
•    Coordinate Trial Steering Committee, Data Monitoring and Ethics Committee and Trial Management Group (TMG) meetings
•    Chair TMG meetings and associated trial meetings
•    Ensure good working relationships between NCTU and its clinical, academic and other partners and collaborators
•    Make independent decisions and to advise and work with others on the trial
•    Take responsibility for identifying your own learning needs, including participating in regular Personal Development Review meetings with a Senior Trial Manager to set development goals and objectives and chart progress in relation to these
•    Liaise with external organisations regularly including NHS Trusts, Universities, funding bodies and UK CRC registered Trial Unit working groups
•    Develop close and effective working relationships with PI’s, CI’s, CTU, NIHR RDS and other colleagues and representative of study sponsors to ensure compliance and provide support in this area
•    Represent the unit at external events as appropriate
•    Undertake other reasonable duties or responsibilities appropriate to the grade as requested from time to time by NCTU
 

The Person 


Knowledge, Skills and Experience 

•    Understanding the principles of management of clinical trials, including the role of a trial manager in the lifecycle of a trial
•    Effective communication and interpersonal skills, including the ability to prepare clear documentation and give oral presentations
•    Exceptional project management skills and organisational ability, capable of prioritising, independently managing workload and working to deadlines
•    Thorough knowledge and understanding of the regulations and guidelines applicable to clinical trials in the UK and the approvals processes
•    A sound knowledge of the principles of Good Clinical Practice
•    Good working knowledge of MS Office applications
•    Attention to detail
Desirable
•    Experience in the management of clinical trials, including medical devices and Clinical Trials of Investigational Medicinal Products, and Advanced Therapeutic Medicinal Products, at sponsor/project management level
•    Understanding of clinical trial/research methodology
•    Experience of performing Site Initiations
•    Experience of central, off-site and site-based monitoring
•    Experience of making applications to regulatory bodies (MHRA) and to ethical committees via IRAS/Combined Review
•    Experience of chairing meetings
•    In-depth knowledge of electronic data capture and data management processes
•    Experience of formal line management
•    Proven experience of budget management

 

Attributes and Behaviour
•    A flexible, logical and analytical approach and the ability to follow and develop processes, address issues and implement solutions to meet the changing needs of the trials
•    Capacity and flexibility to travel occasionally outside of the Newcastle and South Tees areas for monitoring, and meetings
 
Qualifications
•    1st Degree (or equivalent professional qualification and/or experience) in a relevant discipline

Desirable
•    Higher degree in a relevant discipline

 

Newcastle University is committed to being a fully inclusive Global University which actively recruits, supports and retains colleagues from all sectors of society.  We value diversity as well as celebrate, support and thrive on the contributions of all our employees and the communities they represent.  We are proud to be an equal opportunities employer and encourage applications from everybody, regardless of race, sex, ethnicity, religion, nationality, sexual orientation, age, disability, gender identity, marital status/civil partnership, pregnancy and maternity, as well as being open to flexible working practices.

 

The University holds a silver Athena SWAN award in recognition of our good employment practices for the advancement of gender equality. The University also holds the HR Excellence in Research award for our work to support the career development of our researchers, and is a member of the Euraxess initiative supporting researchers in Europe.

 

Requisition ID: 13681