Project Manager – Grade 7 – GLASGOW – Closing Date 17th January 2022

The University of Glasgow is looking to appoint a Project Manager within the Research Institute of Health & Wellbeing.

In this role, you will work on a wide range of project management, trials management and process co-ordination activities within the Robertson Centre for Biostatistics, part of the Glasgow Clinical Trials Unit.

You will be responsible for a varied project portfolio within a clinical research context and supporting key organisational processes in a number of areas including case report form (CRF) requirements gathering, standard operating procedures (SOP) management, safety reporting, endpoints co-ordination and clinical coding.

Clinical trials experience would be useful, but consideration will also be given to strong applicants with a projects management/administrative background in another field. Training and mentoring in clinical trials can be provided to the successful candidate.

For further information on the University of Glasgow’s Institute of Health and Wellbeing please visit: https://www.gla.ac.uk/researchinstitutes/healthwellbeing/

Job Purpose

You will work on a wide range of project management, trials management and process co-ordination activities within the Robertson Centre for Biostatistics, part of the Glasgow Clinical Trials Unit. You will be responsible for a varied project portfolio within a clinical research context and support key organisational processes in a number of areas including case report form (CRF) requirements gathering, standard operating procedures (SOP) management, safety reporting, endpoints co-ordination and clinical coding.
Clinical trials experience would be useful, but consideration will also be given to strong applicants with a projects management/administrative background in another field. Training and mentoring in clinical trials can be provided to the successful candidate.

Main Duties and Responsibilities

1. Responsible for the project management function across a portfolio of projects, prioritising project management solutions to ensure the smooth operation of the Centre’s functions and working with senior staff to determine priorities, establish robust delivery schedules, monitor progress against plans and ensure all deadlines are met. This includes taking personal responsibility for some or all aspects of specific clinical trials or research projects.
2. Responsible for the trials management function across a portfolio of projects, with particular focus on responsibilities in support of clinical trials organisation, including leading on protocol development, patient consent/information sheet development, obtaining MHRA, IRAS and R&D approvals, leading on site setup, initiation and co-ordination, convening meetings (including study status, trial steering, executive, investigator, training and safety committees, including chairing and minute taking as required).
3. Co-ordination of specialist processes in support of clinical trials management, ensuring professional and effective service delivery. These processes include case report form (CRF) requirements gathering/specifications, standard operating procedures (SOP) management, submission of data linkage applications to the NHS/government bodies, safety reporting in line with legal and regulatory requirements (including SUSAR reporting), study endpoints co-ordination and the clinical coding function (adverse events and medications).
4. Develop and maintain excellent working relationships with all relevant stakeholders, including Centre and University colleagues, external clients and study sponsors, engaging on requirements, working collaboratively on identifying solutions, improving efficiency and managing expectations. Liaise and meet with external collaborators and take personal responsibility for entire sections of project management, trials management and organisational work, ensuring completion of work to high standards and in accordance with strict timelines.
5. Responsible for the oversight of administrative staff in the delivery of specific functions and areas of responsibility, ensuring that staff are motivated and supported to meet the needs of operational requirements.
6. Provide senior staff, clients, collaborators and other stakeholders with regular updates and briefings to ensure that they have a clear understanding of status, progress and any emerging risks or issues.
7. Responsible for ensuring quality in all areas of responsibility, including development and review of documentation (including 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 ISO27001 (information security). Prepare for and participate in regulatory audits and inspections.
8. Contribute to the production of research and funding proposals, including input to resource and costing preparation to help ensure external resources are secured to support the Centre’s research functions. Further, contribute to the development and review of contractual agreements and client & regulatory review/assessment documents.
9. Duties of the post outlined are not exhaustive and the post-holder will be expected to be co-operative and flexible, undertaking such 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. The nature of the post may require working outside of normal working hours.

Knowledge, Qualifications, Skills and Experience

Knowledge/Qualifications

Essential:
A1 Scottish Credit and Qualification Framework level 9, (Ordinary Degree, Scottish Vocational Qualification level 4), or equivalent (including professional accreditation with relevant formal training), and experience of personal development in a similar or related role(s)
or Ability to demonstrate the competencies required to undertake the duties associated with this level of post having acquired the necessary knowledge and skills in a similar or number of different roles.

Desirable:
B1 Knowledge of the key areas of clinical trials management (e.g. data collection & management, safety reporting, site setup, clinical trials approvals) as well as the requirements of ICH Good Clinical Practice and other applicable regulatory and data protection requirements.

Skills

Essential:
C1 Strong organisational skills, with excellent knowledge of relevant software packages in support of these (e.g. Word, Excel, Outlook, PowerPoint).
C2 Ability to exercise initiative and take responsibility for ongoing decision making to ensure multiple projects are co-ordinated efficiently.
C3 Strong user-focussed approach with ability to understand and present information in an easy-to-understand format
C4 Ability to cope under pressure while maintaining a high level of accuracy, with ability to work independently, assess priorities and manage own workload effectively.
C5 Excellent interpersonal skills and ability to work as part of a team with staff at all levels.
C6 Reliable, trustworthy and able to maintain confidentiality.
C7 Flexible and committed approach to work

Experience

Essential:
E1 Demonstrable Project Management experience or experience of contributing to project delivery.

Standard Terms and Conditions

Salary will be on the Management, Professional and Administrative Grade, level 7, £36,382 – £40,927 per annum.

New entrants to the University will be required to serve a probationary period of 6 months.

The successful applicant will be eligible to join the University Superannuation Scheme. Further information regarding the scheme is available from the Superannuation Officer, who is also prepared to advise on questions relating to the transfer of Superannuation benefits.

Relocation assistance will be provided where appropriate.

It is the University of Glasgow mission is to foster an inclusive climate, which ensures equality in our working, learning, research and teaching environment.

We strongly endorse the principles of Athena SWAN, including a supportive and flexible working environment, with commitment from all levels of the organisation in promoting gender equality.

The University of Glasgow, charity number SC004401.
Vacancy Ref : 070911 Close Date : 17-Jan-2022 23:45

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