Loading...
Share this Job

Senior Trial Manager

Requisition ID:  11501
Location: 

Newcastle, GB

Contract Type:  Open Ended
Working Pattern:  Full Time
Posted Date:  09-Sep-2021

 

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: £42,149 - £44,706, rising to £50,296 per annum

Closing Date: 28 September 2021

 

The Role

 

We have an exciting opportunity for a Senior Trial Manager within our successful UK CRC registered Clinical Trials Unit.  The Senior Trial Manager will directly manage one or more Trial Managers and other NCTU staff as appropriate. NCTU’s portfolio includes clinical trials across all phases, in support of NCTU strategic aims.  

 

The team requires an enthusiastic and motivated individual, with excellent negotiating, communication and interpersonal skills.  You will have a first degree in a relevant discipline, significant experience in the management of clinical trials and an in-depth knowledge of the provisions of the EU Clinical Trials Directive and the UK Policy Framework for Health and Social Care Research.

 

You will understand and contribute to the scientific, design, regulatory and technical elements of clinical trials and studies, providing advice to ensure they are designed, delivered, and managed effectively and efficiently, in line with sponsor, regulatory and research governance requirements. 

 

You 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.

 

You will work as part of a team of Senior Trial Managers to provide comprehensive management to a portfolio of clinical trials run in collaboration with NCTU. You will understand and contribute to the scientific, design, regulatory and technical elements of clinical trials; you will provide advice to ensure they are designed, delivered and managed efficiently, in line with sponsor, regulatory and research governance requirements.  You will be expected to appropriately handle confidential and sensitive information.  The Senior Trial Manager will directly manager one or more Trial Managers and other NCTU staff as appropriate. NCTU’s portfolio includes clinical trials across all phases, in support of NCTU strategic aims.

 

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, including nationally and internationally.  You will work at both sites depending on the needs of individual trials and NCTU.

 

You will report to the NCTU Senior Leadership Team and work closely with Trial Managers, Data Managers, Investigators, Collaborators, Sponsors and the wider research team to deliver trials including monitoring of and progress against milestone targets, highlighting and managing risks as appropriate.

 

Requests for part time working will be considered. Informal enquiries may be made to Chrissie Butcher (chrissie.butcher@newcastle.ac.uk) and Michelle Bardgett (michelle.bardgett@ncl.ac.uk)    

 

Further information regarding the Newcastle Clinical Trials Unit can be found via the following link: Newcastle Clinical Trials Unit 

 

Interviews will be held on 6th October 2021.   

Key Accountabilities


•    Provide leadership in clinical trial management to enable effective development and delivery of a portfolio of clinical questions to be answered robustly 
•    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, Trial Manager, Data Manager and Statistician) to identify and mitigate risk, agreeing trial timelines and milestones and ensure all processes throughout the trial lifecycle are completed within these, and subsequently agreed, plans
•    Work with the CTU team to ensure timely data cleaning procedures, and quality controls that produce trial data which are accurate, complete and timely
•    Proactively identify any issues within individual trials, appropriately escalating these and finding and implementing solutions (including: recruitment; protocol deviations; serious breaches)
•    Contribute to the costing and management of trial finances; forecasting needs for individual trials; liaising with the NCTU core business team to enable appropriate funding, and financial transactions and reporting in line with the contract
•    Manage the relationship with the Sponsor and Funder to ensure compliance with reporting requirements
•    Work with the grants and contracts team, Sponsor, Trial Manager and others, as appropriate, to ensure that contracts and agreements are in place for individual trials
•    Work as part of the Senior Trial Manager team and with others in NCTU (including QA) to ensure common ways of working and best practice in clinical trial management
•    Take responsibility for collating and reporting management information on clinical trial activities and outcomes, specifically overseeing the governance and reporting structures of trials and ensuring the required data are available for real time tracking of individual trial status
•    To develop, line-manage, support and advise a team of Trial Managers to ensure trials are developed, coordinated and managed effectively and conducted to required standards, including serious adverse event reporting.  This will include being responsible for training, development and PDR of these staff in accordance with NCTU central processes.
•    Advise and manager the wider clinical trial team and associated stakeholders, and committees to ensure efficient operation and delivery
•    To contribute to the development of funding applications, advising on trial design; regulations; monitoring requirements; drug packaging and storage; procurement of other trial supplies and materials; liaison with UK Clinical Research Networks and consumer groups; and other aspects of trial feasibility including recruitment strategies
•    Oversee close down activities including contributing to the funder report and wider dissemination of trial findings
•    Ensure studies are conducted in accordance with GCP and other applicable legislation for Clinical Trials and the General Data Protection Regulation.  
•    Ensure good working relationships between NCTU and its clinical, academic and other partners and collaborators
•    Contribute to, lead on, writing and reviewing of SOP’s and policy documents on clinical trial management systems and processes in collaboration with the QA Team, including the review of quality improvement and other related initiatives
•    Contribute to internal NCTU staff training relating to clinical trial management
•    To contribute to formal and on-the-job training and development on trial related activities
•    Take responsibility for identifying own learning needs, including participating in regular Personal Development Review meetings
•    The post holder will advise on new collaborations, costing and pricing of trial proposals, and advise on staff capacity development and recruitment needs
•    Have extensive contact with internal and external personnel, including other Universities, NHS Trusts and funding bodies. 
•    Represent the Unit at internal and external meetings, creating and building on existing links
•    Support the management of change within NCTU
•    Undertake other duties, appropriate to the grade, which may be required from time to time by NCTU.

 

The Person (Essential)

 

Knowledge, Skills and Experience 


•    Significant experience in the management of clinical trials, at sponsor/project management level
•    In-depth knowledge of the provisions of the EU Clinical Trials Directive and the UK Policy Framework for Health & Social Care Research
•    A sound knowledge of the principles of Good Clinical Practice
•    Experience of making applications to regulatory bodies (MHRA) and to ethical committees via IRAS
•    Experience of managing and developing staff
•    Experience of Chairing meetings
•    Good working knowledge of MS Office applications
•    Effective report-writing and presentation skills
•    Excellent oral and written communication skills
•    Attention to detail
•    The ability to make independent decisions without reference to others in areas of responsibility, as well as effective teamworking
•    Be able to plan and organise both own workload as well as supervise that of others
•    Be able to inform staffing requirements

Desirable
•    Knowledge of clinical trial design
•    Experience of costing of studies
•    Experience of contributing to bid development
•    Experience of using project management software or formal project management techniques
•    Hands-on experience of central and site-based data monitoring


Attributes and Behaviour

 

•    Excellent interpersonal skills
•    Enthusiastic, innovative approach to challenges
•    Ability to work to deadlines, organise own workload and work independently
•    Demonstrated commitment to ongoing personal development and training
•    Desire to spread good practice
•    Flexibility with respect to working hours
•    Willingness to travel outside of the Newcastle and South Tees


Qualifications


•    1st Degree (or equivalent professional qualification) in a relevant discipline
•    Formal training in Good Clinical Practice

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 our Benefits Website page.

Requisition ID: 11501