PM2 - 2018
US ~ Miami
Project Manager II
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Responsible for the day-to-day management and completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget. To ensure excellence of service with the Sponsor throughout the project.
To provide support to project management in the completion of allocated projects to the agreed standards of quality, to agreed timelines and within cost budget.
Other tasks and responsibilities will include:
- Primary contact with the Sponsor from project initiation to operational close out for allocated studies
- Lead the internal project team to ensure timely project communication and delivery throughout the life of the project for allocated studies
- Monitoring and control of allocated project progress to time/quality/cost
- Invoicing and debtor management
- Management of third party and internal suppliers as required
- Documentation of study related communication e.g. minutes, t-cons in a timely manner
- Generation, review and approval of appropriate study-related documentation and reports in line with SOP requirements
- Chair lessons learned meetings as appropriate
- Work with the internal team to identify and have mitigation strategies for project specific risks
- Management of study execution to ensure regulatory approvals, pharmaceutical development work, recruitment and screening of volunteers, clinical manufacturing, clinical operations and data sciences activities are delivered for customers
- Management of close out studies to ensure data queries, post-study reporting to the regulatory authorities, scientific review meetings and archiving are completed in a timely manner for allocated studies
- Oversight of preparation of volunteer information and consent forms and management of the review process
- Tracking of allocated projects in MS Project on a real time basis
- Oversight of the Investigator Site File and Trial Master File as required
- Application of lessons learned from previous studies to ensure continuous improvement in delivery
- Participate in Sponsor monitoring visits and site visits as required
- Ensure data queries are resolved to ensure database lock can occur as planned
- Support commercial activities e.g. RFI support, review of repeat business proposals etc.
- Support other aspects of the business as needed
- Minimum degree qualification or equivalent
- At least 4 years experience of working in a clinical research/manufacturing environment or relevant related experience
The job may involve the following:
- Very high concentration of work
- Strict and tight deadlines
- Having to juggle a range of tasks/issues simultaneously
- Working outside normal working hours
- Needing to respond to client demands
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.