Senior Trial Manager

Found in: Talent UK C2 - 2 weeks ago

Newcastle upon Tyne, United Kingdom Newcastle University Full time

The Role


The post is based within the UKCRC registered Newcastle Clinical Trials Unit (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 40 active trials being conducted by NCTU. NCTU works with multiple trial sponsors, locally, nationally and internationally and from its hub based in Newcastle. 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.

This post is full-time and open-ended.

Further information can be obtained by contacting or

Find out more about the Faculty of Medical Sciences here:

Find out more about our Research Institutes here: 

As part of our commitment to career development for research colleagues, the University has developed 3 levels of . These profiles set out firstly the generic competences and responsibilities expected of role holders at each level and secondly the general qualifications and experiences needed for entry at a particular level.

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 You 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 

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 Newcastle

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 a global University where everyone is treated with dignity and respect. As a University of Sanctuary, we aim to provide a welcoming place of safety for all, offering opportunities to people fleeing violence and persecution.

We are committed to being a fully inclusive 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 of our employees and the communities they represent. We are proud to be an equal opportunities employer and encourage applications from individuals who can complement our existing teams, we believe that success is built on having teams whose backgrounds and experiences reflect the diversity of our university and student population.

At Newcastle University we hold a silver award in recognition of our good employment practices for the advancement of gender equality. We also hold a Bronze award in recognition of our work towards tackling race inequality in higher education REC. We are a employer and will offer an interview to disabled applicants who meet the essential criteria for the role as part of the offer and interview scheme.

In addition, we are a member of the Euraxess initiative supporting researchers in Europe. 

Requisition ID: 26823


We ensure there's something for everyone and these benefits include: a cycle-to-work schemeshopping discountscompetitive pension schemehealth and wellbeing initiativesactivities and eventsgenerous leavediscounted travelChristmas shutdown

  • Senior Trial Manager

    Found in: beBee jobs GB - 2 weeks ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Newcastle University Full time

    Company description: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: £45,585 to £48,350 with progression to...

  • Clinical Trials Assistant

    13 hours ago

    Newcastle upon Tyne, United Kingdom The Newcastle upon Tyne Hospitals NHS Foundation Trust Full time

    A Clinical Trials Assistant will provide technical support to clinical trials services and the wider clinical trials team with the aim of providing safe management of clinical trials patients within the hospital and community. To carry out the full range of Clinical Trials Assistant duties including but not limited to the following: Responsibilities To...

  • Head of Operations

    3 days ago

    Newcastle upon Tyne, United Kingdom Newcastle University Full time

    **Salary**: £56,021 to £59,421, with progression to £64,914 per annum Newcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you. **Closing Date**: 14 February 2024 The Role Do you...

  • Senior Behavioural Insight and Trials Advisor

    7 days ago

    Newcastle upon Tyne, United Kingdom HM Revenue and Customs Full time

    **Details**: **Reference number**: - 278214**Salary**: - £41,782 - £48,566- National £41,782 - £44,932 and London £45,170 - £48,566**Job grade**: - Senior Executive Officer**Contract type**: - Permanent**Business area**: - HMRC - CS&TD - Customer Insight & Design**Type of role**: - Analytical - Customer Insight - Market Research - Operational...

  • External Audit Senior Manager

    Found in: Talent UK C2 - 1 week ago

    Newcastle upon Tyne, United Kingdom Hays Senior Finance Full time

    External Audit Senior Manager Employer Location Newcastle upon Tyne, Tyne and Wear, England Salary GBP66000.0 - GBP75000.0 per annum + From £66,000 to £75,000 Closing date 20 Mar 2024 View more Sector Salary band , Hours Where will they be working? You need to or to save a job. Job Details Your new company High profile public services...

  • Trial Coordinator

    12 hours ago

    Kingston upon Hull, United Kingdom University of Hull Full time

    **Reference**: - EST-012-LG**Campus**: - Hull**Faculty/Area**: - Faculty of Health Sciences**School/Department**: - Hull York Medical School**Subject Group/Team**: - Hull Health Trials Unit**Salary**: - £30,619 to £36,333 per annum- Fixed Term 2 years**Post Type**: - Full Time**Closing Date**: - Wednesday 07 June 2023The University of Hull is...

  • Management Accountant

    4 days ago

    Newcastle Upon Tyne, United Kingdom Blair West Full time

    Blair West are working in partnership with, Adderstone Group, a North East based property developer whose portfolio consists of commercial, residential, regeneration and social housing. The business has an opportunity for a Management Accountant to jointheir Accounts Team. **The Role**: - You will manage a portfolio of property companies and partnerships...

  • Senior Process Engineer

    3 days ago

    Newcastle upon Tyne, United Kingdom Imperial Recruitment Group Full time

    Job Title: Senior Process Engineer Location: Teesside, North East England - Relocation Supported Package: Competitive basic + Performance Bonus + Relocation Package Employment Opportunity: Permanent Overview of the role: The overall purpose of the Senior Process Engineer role is to provide technical, operational, and process safety support to the...

  • Case Progression Officer

    3 days ago

    Newcastle upon Tyne, United Kingdom HM Courts and Tribunals Service Full time

    **Details**: **Reference number**: - 260986**Salary**: - £25,827 - £27,170**Job grade**: - Executive Officer- EO**Contract type**: - Permanent**Type of role**: - Operational Delivery**Working pattern**: - Flexible working, Full-time, Job share, Part-time**Number of jobs available**: - 1Contents Location About the job **Benefits**: Things you need...

  • Case Progression Officer

    3 days ago

    Newcastle upon Tyne, United Kingdom Ministry of Justice Full time

    **Case Progression Officer - Middlesborough / Newcastle Upon Tyne - 69080** **£25,827 - £27,170** **Newcastle-upon-Tyne**: **Pay Span or equivalent: Band EO**: **Background**: The Tribunals Service and HM Court Service were integrated into a single Agency, HM Courts and Tribunals Service on 1st April 2011. Bringing these two organisations together has...

  • Business Development Manager

    Found in: Talent UK 2A C2 - 2 weeks ago

    Newcastle upon Tyne, United Kingdom Life Sciences Recruitment Full time

    Life Sciences Recruitment is pleased to confirm that we are working with a rapidly growing, global client that provides a variety of unique clinical trial services to the Life Science industry with a key focus on secondary packaging and labelling.We're looking for a full-time Business Development Manager with extensive experience in working in end-to-end...

  • Clinical Research Associate

    7 days ago

    Newcastle upon Tyne, United Kingdom Newcastle University Full time

    **Salary**: £31,623 to £53,132 per annum Newcastle University is a great place to work, with excellent benefits. We have a generous holiday package; plus the opportunity to buy more, great pension schemes and a number of health and wellbeing initiatives to support you. **Closing Date**: 24 March 2023 The Role An exciting opportunity has arisen for a...

  • Management Accountant

    Found in: beBee S GB - 3 weeks ago

    Newcastle Upon Tyne, United Kingdom Ryanair Full time

    We are looking to recruit a talented and highly motivated Management Accountant to join our quickly growing team. The role will be based in our Prestwick facility.Duties. To Provide detailed, timely and accurate financial reports (Cashflow, Balance Sheet, Fixed Assets, Profit and Loss, Trial Balance and other necessary ad-hoc financial reports)Manage the...

  • Tax Manager

    5 days ago

    Newcastle Upon Tyne, United Kingdom Adele Carr Recruitment Full time

    Tax Manager / Senior Manager - flexible working available. Salary range £45,000 to £75,000 We are delighted to be working with this well large independent client in the North East who due to continual growth are looking for a Tax Manager or Senior Manager to come on board with their Personal tax team. The client is a large firm several offices acrossNorth...

  • Senior Investment Manager

    Found in: Jooble UK C2 - 2 weeks ago

    Newcastle upon Tyne, United Kingdom IDEX Consulting Ltd Full time

    Senior Investment Manager | Newcastle £75k - £100k basic salary DOE + annual, discretionary bonus HNW clients to inherit IDEX are recruiting exclusively on behalf of a National Wealth Management firm who require a senior level Investment Manager to join their established Newcastle offices. With responsibility for over £2bn AUM, the office is one of...

  • Senior Investment Manager

    1 week ago

    Newcastle upon Tyne, United Kingdom IDEX Consulting Ltd Full time

    Senior Investment Manager | Newcastle £75k - £100k basic salary DOE + annual, discretionary bonus HNW clients to inherit IDEX are recruiting exclusively on behalf of a National Wealth Management firm who require a senior level Investment Manager to join their established Newcastle offices. With responsibility for over £2bn AUM, the office is one of...

  • Drug Safety Associate

    Found in: Talent UK 2A C2 - 4 hours ago

    Newcastle upon Tyne, United Kingdom wax. Full time

    The Drug Safety Associate plays a crucial role in ensuring the safety and compliance of pharmaceutical products throughout their lifecycle. This position involves managing pharmacovigilance (PV) vendor contracts, conducting quality control processes for PV and risk management training trackers, and supporting post-marketing reconciliation activities. The...

  • Senior Investment Manager

    Found in: Appcast UK C C2 - 1 week ago

    Newcastle Upon Tyne, United Kingdom IDEX Consulting Ltd Full time

    Senior Investment Manager | Newcastle£75k - £100k basic salary DOE + annual, discretionary bonusHNW clients to inheritIDEX are recruiting exclusively on behalf of a National Wealth Management firm who require a senior level Investment Manager to join their established Newcastle offices. With responsibility for over £2bn AUM, the office is one of the...

  • Senior Investment Manager

    Found in: Whatjobs ES C2 - 6 days ago

    Newcastle Upon Tyne, United Kingdom IDEX Consulting Ltd Full time

    Senior Investment Manager | Newcastle £75k - £100k basic salary DOE + annual, discretionary bonus HNW clients to inherit IDEX are recruiting exclusively on behalf of a National Wealth Management firm who require a senior level Investment Manager to join their established Newcastle offices. With responsibility for over £2bn AUM, the office is one of the...

  • Senior Investment Manager

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Newcastle Upon Tyne, United Kingdom IDEX Consulting Ltd Full time

    Senior Investment Manager | Newcastle£75k - £100k basic salary DOE + annual, discretionary bonusHNW clients to inheritIDEX are recruiting exclusively on behalf of a National Wealth Management firm who require a senior level Investment Manager to join their established Newcastle offices. With responsibility for over £2bn AUM, the office is one of the...