The Clinical Research Facility (CRF) is looking for a Band 6 Research Project Manager. The CRF is a Phase 1 MHRA accredited unit, the first NHS trust in England and Wales to achieve this standard.
The role of the Research Project Manager will involve working on a number of CRF Clinical Studies, across multiple Clinical Disciplines. The Project Manager in collaboration with the study team will be responsible for setting up, ongoing management of and close out of their assigned research projects.
Joining the CRF is a fantastic opportunity to be part of a dynamic and growing team that is dedicated to delivering high quality research projects, with both our academic and commercial collaborators.
Main duties of the job
The post holder will co-ordinate Early Phase CRF led Clinical trials under leadership direction of the Principal Investigator and CRF Operational Support Manager. Responsibilities typically include contributing to the development and management of the protocol, budget, timeline, quality guidelines and being the primary point of contact for the Sponsor, thereby ensuring that expectations are met while identifying and mitigating risks.
The Project Manager also compiles and drives documentation for the project, ensuring the accuracy and quality of regulatory data including Ethics Submissions.
The successful applicant must have excellent communication and interpersonal skills and have the ability to work independently, to prioritise their own workload and to communicate effectively with both internal and external members of the research team with the ability to meet tight deadlines.
All clinical research activity must be compliant and conducted in accordance with European Union (EU) Directive, ICH/GCP International Conference on Harmonisation and Good Clinical Practice (GCP).
Job responsibilities
1. With mentorship from a more Senior Manager, lead the core project team and facilitate the team's ability to lead extended/completed the project to time and target.
2. Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services.
3. Manage and track project resource needs and contribute to contingency planning for key resources.
4. Create required project plans utilising appropriate planning software. Implement and monitor progress against project plans and revise as necessary.
5. Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations.
6. Oversee/complete accurate and timely Ethics/R&D Submissions in conjunction with the Lead Nurse.
7. Serve as client/sponsor/internal stakeholders primary contact for assigned studies.
8. Contribute to effective teamwork among project team members.
9. Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects.
10. Meet/exceed client/sponsor satisfaction expectations.
11. Present at external and/or internal meetings, with support from a more senior manager or Principal Investigator as needed.
12. Assist in ensuring that all staff allocated to assigned projects adhere to professional, SOP, and specific GCP and ICH standards.
13. Provide performance feedback on team members to respective supervisors.
14. Review proposals and budgets.
15. Follow defined project issue escalation process.
16. With support from more senior management positions and the Principal Investigator, monitor and control the risk plan and provide ongoing oversight to ensure mitigation plans are in place and working. Escalate risks newly identified by the project team to stakeholders.
17. With support from more senior management positions, meet financial performance targets for the assigned projects and proactively identify out of scope activities and execute necessary work scope change orders.
18. Collaborate with the RD&I Business team to initiate monthly invoicing, as appropriate.
19. Ensure that monitoring reports and monitoring visits are completed in a timely manner. Review monitoring reports and escalate issues.
20. Establish working relationships with clients/sponsors which result in client satisfaction, operational excellence and thereby increase potential for repeat business.
21. Contribute and participate in the delivery of presentations for new business, as required.
22. Track client project metrics.
23. Ensure that internal project review meetings are conducted as needed. Depending on size and scope of project, lead meetings as appropriate.
24. Perform other duties as assigned by management.
Person Specification
Qualifications
Essential
* Graduate with Hons Degree, preferably in a science or clinical area.
Desirable
* Relevant clinical research experience in a pharmaceutical company/CRO including study management and/or project management experience.
Experience
Essential
* Demonstrable experience in managing or co-ordination of clinical studies.
* Experience in effective use of Microsoft Office package including Microsoft Project or other planning software.
Desirable
* Experience of liaison with staff at all levels in the NHS, Universities and Industry.
* Leadership/management experience and examples of.
* Experience of being a client/sponsors primary point of contact.
* Experience in Phase I Clinical Trials.
Skills
Essential
* Good communication, presentational, training and interpersonal skills.
* Ability to use a personal computer.
* Skills in administration & project management.
* Ability to meet tight deadlines and cope in a highly demanding environment.
* Ability to work independently and prioritise/own workload and to communicate effectively with all members of the multi-disciplinary team.
* Ability to liaise with clients/sponsors in a professional manner.
* Good planning and organization skills.
Desirable
* Skills in handling and management of computerised data.
* Skills required to evaluate and assist in developing new protocols.
* Skills in the analysis and interpretation of data.
Other
Essential
* Meticulous attention to detail and a high standard of accuracy.
* Flexible approach to working hours.
Knowledge
Essential
* Knowledge of the principles & practice of clinical research and/or clinical trials.
* Knowledge of ethical and quality standards applicable to clinical trials, including EU Directive ICH/GCP requirements.
* Demonstrate knowledge of NHS Research Governance.
* Understanding of the drug development process.
* Ability to understand and work with financial information.
* Working knowledge of project management processes.
Employer details
Employer name
Liverpool University Hospitals NHS Foundation Trust
Address
Clinical Research Facility, Royal Liverpool University Hospital site
Prescot Street
Liverpool
L7 8XP
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