Senior Project Manager
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Job Purpose
To be responsible for a significant project portfolio within a clinical research context and, in conjunction with the existing Senior Project Manager, you will lead on related organisational processes, (e.g. safety management, endpoints co-ordination and clinical coding).You will contribute towards the running of the Centre's Projects Management and Administration team, managing staff and overseeing related activities where appropriate, as well as contributing to the Centre's policy at a senior level.
Main Duties and Responsibilities
1. To play an active role in developing and leading on the project management function within a clinical research and data management/statistical environment based within the Robertson Centre.
2. To contribute to the wider operational functions across the Centre by working collaboratively to strengthen cross-functional processes, systems and interactions, generating ideas and solutions with broad and beneficial impact.
3. To lead in the delivery of enhanced project management solutions in support of world-class clinical research, managing change in a positive and supportive way.
4. Responsible for driving the project lifecycle across a wide portfolio of projects, involving prioritising project management solutions to ensure the smooth operation of the Centre's functions; working closely with senior management to identify priorities, allocate resource, establish robust delivery schedules, monitor progress against plans and ensure all deadlines are met. This includes having ownership for some and/or all aspects of specific clinical trials or research projects.
5. Develop and lead the trials management function, with particular focus of clinical trials organisation leading on protocol development, patient consent/information sheet development, obtaining MHRA (Medicine and Healthcare products Regulatory Agency), IRAS (Integrated Research Application System) and R&D (Research and Development) approvals, and leading on site setup and planning.
6. Working in the context of a clinical trials unit specialising in the provision of high-quality data management and biostatistical analysis, using knowledge of these areas to support excellence in deliverables, milestone-planning and client communications (for example, compiling system specifications for clinical trials data collection, managing timelines for committee reporting to executive and safety committees, initiating process improvement planning across the different functional areas, supporting sites and chief investigator in understanding query reports, managing and documenting data-centric processes such as database lock).
7. Convening meetings (including trial steering, executive, investigator, training and safety committees), including minute-taking and chairing as required.
8. To play a leading role in the management of clinical related processes across the Centre, ensuring professional and effective service delivery (e.g. the co-ordination of safety reporting in line with legal and regulatory requirements including SUSAR (Suspected Unexpected Serious Adverse Reaction) reporting), leading on study endpoints co-ordination and the clinical coding function (adverse events and medications) whilst maintaining awareness and providing research governance expertise for all relevant staff involved in these processes.
9. To actively develop, enhance, and maintain collaborative working relationships with key stakeholders, (e.g., Centre and University colleagues, external clients and study sponsors), to identify solutions, improve efficiency and manage expectations.
10. Working closely with external collaborators to engage and oversee on all aspects of the project management, trials management and organisational work, as well as delegating responsibilities to project teams within the Centre, and ensuring completion of work meets high standards and required timelines.
11. To lead on the development and oversight of other project management and administrative staff to deliver a large portfolio of clinical trials and other medical research projects, ensuring that staff are committed, motivated and supported to meet the needs of future research and operational requirements.
2. Provide regular reports to senior management, clients, collaborators and other stakeholders with updates and briefings to inform of status, progress and any emerging risks or issues.
13. Responsible for ensuring research governance and related obligations are met by ensuring quality standards in all areas of responsibility, including development and review of documentation (e.g. standard operating procedures, guidelines, forms and study-specific work instructions) to manage processes in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 (Good Clinical Practice), ISO 9001 (quality management) and ISO 27001 (information security). Prepare for and participate fully in regulatory audits and inspections.
14. Contribute towards the production of research and funding proposals, providing specialist advice and input to resource and costing preparation to ensure external resources are secured to support the Centre's research functions. In addition, make a leading contribution to the development and review of contractual agreements and client & regulatory review/assessment documents.
15. Duties of the post outlined are not exhaustive and the post-holder will be expected to undertake duties as may be reasonably expected by management. The duties of the post will be subject to review in line with changing requirements, both internal and external.
Knowledge, Qualifications, Skills and Experience
Knowledge/Qualifications
Essential
A1. Ability to demonstrate the competencies required to undertake the duties associated with this level of post having acquired the necessary professional knowledge and management skills in a similar or number of different specialist roles.
Or: Scottish Credit and Qualification Framework level 9,10 or 11 (Ordinary/Honours Degree, Post Graduate Qualification), or equivalent, including being professionally qualified in relevant discipline, with a broad range of professional experience in a management role(s).
A2. Extensive knowledge of all areas of project management in a clinical trials context.
A3. Extensive knowledge of all areas of trials management in a clinical trials context.
A4. Extensive knowledge of the requirements of ICH Good Clinical Practice and all other legal, regulatory and data protection requirements in the management and co-ordination of clinical trials.
A5. Extensive knowledge of safety reporting requirements for clinical trials, medications and events coding dictionaries and the role of clinical endpoints reporting.
A6. Extensive knowledge of key areas of data management, including data collection, data protection, controller/processor roles, making record linkage applications and the importance of quality functions.
Skills
Essential
C1. Specialist skills and expertise in the area of project management at an appropriate level
C2. Specialist skills and expertise in the area of trials management at an appropriate level.
C3. Effective staff management skills and the ability to plan and delegate appropriately.
C4. Strong user-focussed approach with ability to understand and present complicated information in an easy-to-understand format and with ability to give presentations and lead on training sessions.
C5. Ability to cope under pressure while maintaining a high level of accuracy, with ability to work independently, assess priorities and manage own workload effectively.
C6. Excellent interpersonal skills and ability to work as part of a team with staff and clients at all levels and in a variety of contexts.
C7. Reliable, trustworthy and able to maintain confidentiality.
Experience
Essential
E1. Significant experience in project management within a clinical data management and biostatistical context.
E2. Significant experience in clinical trials management, for example study site setup and close down, protocol development, regulatory applications, patient consent forms/patient information sheets, meeting organisation (at steering committee level or similar).
E3. Significant experience in supporting clinical organisational functions, for example safety reporting, endpoints co-ordination, clinical trials essential document archiving and medical coding.
E4. Significant experience in providing project support functions such as development of data collection specifications/case report forms, organisation of key meetings (e.g. study setup/progress/closedown meetings, database lock meetings), record linkage coordination.
E5. Experience in staff management and mentoring.
Terms and Conditions
Salary will be Grade 8, £49,250 - £56,921 per annum.
This post is full time and open ended.
Informal enquiries may be directed to Elizabeth Anderson: Liz.Anderson@glasgow.ac.uk
The University of Glasgow has a responsibility to ensure that all employees are eligible to live and work in the UK. If you require a Skilled Worker visa to work in the UK, you will be required to meet the eligibility requirements of the visa route to be assigned a Certificate of Sponsorship.
Please note that this post may be eligible to be sponsored under the Skilled Worker visa route if tradeable points can be used under the Skilled Worker visa rules.
For more information please visit: https://www.gov.uk/skilled-worker-visa
Closing date: 23:45 on Thursday 13th February 2025