Description

 Illingworth Research Group Ltd

Start-up Manager

Summary:
The Global Project Start-up team (GSUT) focuses on the effective start-up of Illingworth Research Group Ltd and associated companies (hereinafter ‘’Illingworth’’) Research Nursing (RN) projects to time and budget targets ensuring high quality, consistency and efficiency in the set-up and documentation of projects.

The Global Project Start-up Manager (SUM) is part of the interdisciplinary project team and is responsible for the Start-up Activities from the point of contract signature to completion of project set-up ensuring that the project is set up in a timely manner and to a high standard building the foundations for the future success of the project.

In addition to the Start-up activities the SUM will collaborate closely with the Global PM to ensure that the study budget reflects the scope of work following the initiation of the project, that risks are identified and logged and that a good working relationship with the client is established.

Responsibilities:
1. The start-up of allocated RN projects in accordance with the appropriate clinical SOPs, GCP and all applicable regulatory requirements.
2. Work with the Global Project Manager and assigned project team to ensure the project is set-up within the required timeframe and to a high quality.
3. Support the Global Project Manager with the planning, execution and follow-up of Client Kick-off meeting and Project Launch meetings. Ensuring that all key areas are discussed and that any relevant actions are clear, assigned to the relevant team members and completed within the assigned time period.
4. Oversee development and design relevant materials for research nursing projects including preparation of study specific manuals, visit worksheets and training materials.
5. Develop a project plan to cover the start-up activities including timelines and risks/mitigations. Oversee productions and maintenance of study project trackers and ensure the most up to date and accurate information is captured.
6. Understand budget, finance documents and processes, and project reports, to provide effective coaching and mentorship to other start-up team / project team members, where required.
7. Propose and agree a suitable method for study site engagement as best suits the project, then work with the client and project management team to promote good up-take of the service and work to resolve issues that may impede up-take as these become known.
8. Collaborate with the Research Nursing Management team and Recruitment team for the identification and selection of suitable personnel for research nursing projects, gaining approval for Research Nurses (RN) to work with allocated trial sites.

9. Oversee the contracting of study specific vendors (e.g. couriers and RN vendors) and instruct equipment coordinators on the procurement and organization of clinical equipment and materials for Research Nurses.
10. On the completion of Start-up activities, collate KPIs and conduct lessons learnt and project reviews with the start-up team, other Illingworth business units and the client, to build a knowledgebase to inform process improvements.
11. Review and comply with Standard Operating Procedures (SOPs) and Working Instructions (WIs) in a timely manner, keep training records updated accordingly and ensure timesheet compliance.
12. Stay informed as to relevant skills and qualifications levels required by team members for effective performance. Maintain and share knowledge of all relevant guidance, regulations, and procedures. with colleagues to ensure best practice.

Qualifications

Knowledge, Skills & Abilities
1. A minimum of 2 years of project/programme management experience, preferably working in clinical research
2. Experience in a contract research organization or pharmaceutical industry essential
3. Strong knowledge of the clinical development process
4. Global project management and start up experience– delivery of projects to tight timelines, to budget and to quality standards
5. Excellent organisational, problem solving and analytical skills
6. Ability to prioritise and manage multiple tasks
7. Excellent interpersonal communication and presentation skills
8. Ability to deputise and lead in absence of AD/D
9. Good working knowledge of computer software including Outlook, Word, Excel and PowerPoint