Trial Manager

Faculty of Medical Sciences

Newcastle University, Newcastle upon Tyne, UK

Overview

  • Posted on: 09th Nov 2021
  • Salary: £31,406 - £33,309, rising to £40,927per annum
  • REF: 13681
  • Closes: 29th November 2021
  • Contract Type: Permanent
  • Hours: Full Time, Part Time

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.

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

Closing Date: Monday 29thNovember

The Role

We have an exciting opportunity for Trial Managers within our successful and expanding UKCRC Registered Clinical Trials Unit.

Working within a multi-disciplinary team, you will deliver a portfolio of early and/or late phase trials to time and target, ensuring trials are managed in line with sponsor, regulatory and research governance requirements. You will have a first degree in a relevant discipline, experience and formal training in Good Clinical Practice and will possess the necessary regulatory knowledge. You will need excellent communication and presentation skills, and the ability to organise and prioritise your work and manage others. You will need to be proactive and demonstrate innovation and a focus on solutions when faced with challenges. Enthusiasm, consistent attention to detail, excellent organisational and interpersonal skills, and time management skills are essential for this role.You will be able to think critically and have the ability to rapidly assess and link information. You will be expected to appropriately handle confidential and sensitive information. You will work well both in a team and independently, with the ability to prioritise duties in a busy environment, whilst handling trial related tasks in an efficient, effective and friendly manner.

The posts will support trials in both Newcastle and in our hub at The James Cook University Hospital. You will work at both sites depending on the needs of individual trials and NCTU.

Requests for part time working will be considered.Informal enquiries can be made to Chrissie Butcher (chrissie.butcher@ncl.ac.uk) and Michelle Bardgett (michelle.bardgett@ncl.ac.uk) Further information about the NCTU can be found via the following link: http://www.ncl.ac.uk/nctu/about/

The post is within the UK CRC registered Newcastle Clinical Trials Unit (NCTU). 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.

There are currently approximately 50 active trials being conducted by NCTU. NCTU works with multiple trial sponsors, locally, nationally and internationally and from two main hubs in Newcastle and South Tees. Chief Investigators, Principal Investigators and Co-Investigators are located throughout and beyond the University. You will be expected to work at both sites depending on the needs of individual trials and NCTU. It is likely that you will be working on a portfolio of between 2 and 4 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.

There will be opportunity to input academically and operationally to trial development and to have this recognised in publications.

Interviews will be held on the 6th December

Key Accountabilities

• Working as part of a trial team, provide day to day management of 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
• Perform site initiation visits and train site personnel in trial protocols and procedures during the trial
• Monitor clinical trials at 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 Manager 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

Essential

• Understanding the principles of management of clinical trials, including the role of a trial manager in the lifecycle of a trial
• Knowledge of the provisions of the EU Clinical Trials Directive and the UK Policy Framework for Health and Social Care Research
• A sound knowledge of the principles of Good Clinical Practice
• An understanding of the process for making applications to regulatory bodies (MHRA) and to ethical committees via IRAS
• Good working knowledge of MS Office applications
• Experience of project planning and management
• Excellent interpersonal, oral and written communication skills
• Effective report writing and presentation skills
• Ability to make independent decisions and to work independently, alongside excellent team working skills
• Ability to work to deadlines and organise own workload
• Excellent organisational and administrative skills
• Production of high quality documents and reports
• Appropriately handle confidential and sensitive information

Desirable

• Experience in the management of clinical trials, at sponsor/project management level
• Experience of performing Site Initiation Visits
• Experience of central and site-based monitoring
• Experience of making applications to regulatory bodies (MHRA) and to ethical committees via IRAS
• Experience of Chairing meetings

Attributes and Behaviour

• Enthusiastic, innovative and proactive approach to work; able to think critically and have the ability to rapidly assess and link information
• Demonstrated commitment to ongoing personal development and training
• Attention to detail
• Flexibility with respect to working hours
• Willingness to travel outside of the Newcastle and South Tees areas

Qualifications

Essential

• 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.

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 ourBenefitsWebsite page.

Requisition ID: 13681

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