The Project Manager is responsible for the development, conduct and completion of research projects in accordance with the reasonable requirements of the originator of the project. The Originator of the Project may be an internal research division or an external sponsor.
All activities must be conducted in accordance with project specific documentation, applicable SOPs, ICH GCP and applicable regulatory requirements.
Maintain effective professional relationships with external customers, investigators and vendors. Maintain effective professional relationships with internal project team including those providing academic input.
Provide clear guidance to project team on project specific deliverables.
Attend relevant project specific meetings including formal kick-off meetings
Develop project plan and other internal project management documents.
Assist the originator of the project in the development of project specific documents such as protocol and participant information forms as requested.
Coordinate the feasibility planning and selection process of project sites
Identify project specific activities that need to be out-sourced and be involved in the selection of suitable vendor/s.
Manage the implementation, ongoing evaluation, prioritisation, reporting and timely delivery of all operational aspects of allocated project/s including:
Contribute to the preparation of project specific budget where applicable
Track budget for allocated portion of project.
Deliver relevant portion of project specific budget by guiding team and vendors on project scope, and forecasting and invoicing as agreed with customer.
Track project scope and propose scope changes for assessment
Work with relevant personnel to identify potential clinical sites, oversee or conduct feasibility through questionnaire, interview and/or site visit as applicable.
Oversee the set-up of sites within relevant region in accordance with SOPs, protocol and all applicable regulatory guidelines.
Contribute to the calculation of project staffing levels
Contribute to the identification of appropriate materials for project
Monitor project progress against timelines
Deliver project specific milestones as agreed with customer.
Coordinate project administration eg study management committee meetings, project newsletters
Coordinate and drive internal project team to meet project specific deadlines.
Liaise with centre staff to ensure effective local management
Drive project team to deliver clean, accurate and verifiable data for interim and final analyses
Assist with the development of project documentation eg site manuals, operating procedures
Review and sign-off monitoring visit reports
Ensure patient safety and adverse/serious adverse events are reportedaccording to regulatory requirements
Initiate filing conventions for the project and team is trained on requirements
File and archive clinical project data at end of project
Provide or contribute to progress reports for project originator and other stakeholders
Maintain regular contact with project team including academic leads
Maintain contact with National Coordinators working within allocated region
Be available as back-up contact for site staff on all project related matters
Where applicable liaise with staff in Data Management and Statistics
Divisions on project specific deliverables
The Project Manager has a functional responsibility to Senior Project Manager and project responsibility to the Originator of the Project. The Project Manager will be allocated clinical operations staff to assist with project implementation, administration and monitoring.
Skills, Knowledge and Experience
Previous experience working on clinical projects within an academic, CRO orpharmaceutical environment.
Demonstrated project management skills and ability and/or previous experience supervising project related tasks of other people.
Excellent interpersonal skills, presentation skills and team leadership ability, including leading virtual teams in a cross cultural environment and dealingwith conflict.
Working knowledge and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions.
Technological proficiency including Microsoft Office suite (Word, Excel,PowerPoint, Outlook, Project), clinical trials management software, and the Internet.
Ability to travel (up to 25%)
Ability to see the big picture, yet still focus on detail and quality of work
Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments.
Type of career: Jobs
Application close date: 08/09/2015