We have a fantastic opportunity for an experienced Project Coordinator / Senior Project Coordinator to join our team in Leeds.
The successful candidate will become a member of our "Project Management Academy" giving excellent opportunities for support and development to fast track their career towards Clinical Project Management. The right candidate will show strong potential to develop their career in this area, and will bring the right 'can do' attitude and core skills to develop a great career with Covance!
Essential Job Duties:
Project expertise for CTMS reporting, study metrics, risk management regarding communication, coordination, and eTMF quality.
Able to co-ordinate and manage support across large global study
Applies therapeutic knowledge to daily activities of the clinical trial, brings new knowledge to the team, drives best practices in coordination, communication and documentation
Primary responsibility for the coordination and completion of all administrative functions in support of the project manager.
Job duties include:
Provides administrative support for effective Clinical Trial Core Team Operations
Provides support with assisting with all aspects of project (financials, enrollment, vendors, etc).
Attend and coordinate study meetings internal, sponsor, (including KOM, IM, as needed, working with Scarrit as needed).
Develop Protocol Tools, Coordinate study plans and development and support management of study plans, guidelines, utilized MS Project for timelines with the ICRA
Develop Inv Training
Regulatory/Pharmacy Binders and study materials.
Create and revise Project Specific Forms
Payments for manually tracked (AsiaPac)
ADI logs and Agenda/minutes/Slide decks
Manage and maintain Sponsor system portals
Provides Site and team communications
Drafts and formats Newsletters
Assist with coordinating Audits (assist in response to internal audits and CAPA resolutions)
Follow up on Governace portal issues
Trackers (including financial and vendors)
Performs other duties as assigned by management to support study teams and needing collaborative support
Education / Qualifications
University/college degree in life science or related subject, or certification in an allied health profession (i.e. nursing, medical or laboratory technology).
- Knowledge of the clinical trial process with early clinical pharmacology experience preferred
- Computer competency with various programs (e.g., Microsoft Word, Excel, Project, Access and Power Point)
- Ability to develop accurate study related documents with minimal supervision
- Ability to communicate verbally and in writing
Experience in clinical research, and ideally project coordination required.
We can consider a Senior level role for a candidate who has already gained strong experience in a similar role.
Strong administration and communication/customer service experience essential