Project Manager II
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- 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.
- To comply & adhere to GCP guidelines and regulations as required of this role.
Main 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
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 in a hazardous environment with high requirement to follow safety procedures
- Working outside normal working hours
- Needing to respond to client demands
- Minimum degree qualification or equivalent
- At least 4 years experience of working in a clinical research/manufacturing environment or relevant related experience
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.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at firstname.lastname@example.org.