Regional Project Lead

PSI CRO

About The Position

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. The Regional Project Lead manages and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions. They ensure meeting study milestones are met by the project team on a country and regional level.

Requirements

College/University degree in Life Sciences or an equivalent combination of education, training & experience is required
Prior experience in Clinical Research and on-site monitoring is required
Experience as a Study Manager/Clinical Trial Manager with the ability to supervise project activities as a Regional Lead or equivalent is required
Experience in Oncology is required
Full working proficiency in English
Proficiency in MS Office applications, including MS Project
Communication, presentation and customer-service skills
Ability to negotiate and build relationships at all levels
Team building, leadership and organizational skills

Nice To Haves

Experience in GI is preferred

Responsibilities

Ensures planning, implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents)
Acts as primary or secondary project management contact for the project team and PSI support services in designated countries
Performs study status review and progress reporting (if delegated by the Project Manager)
Collects and reports project status updates for designated regions, both internally and externally
Develops and updates project planning documents, essential study documents and project manuals/ instructions
Manages and reports on Key Performance Indicators (KPIs) for designated countries and clinical project team members
Ensures that the project timelines and subject enrollment targets are met in designated countries
Coordinates maintenance of study-specific and corporate tracking systems
Coordinates site contractual startup and budget negotiations
Establishes communication lines within the project team and supervises clinical project team members’ performance
Identifies, escalates and resolves resourcing and performance issues
Conducts and supervises therapeutic area training of the project team (if delegated by the Project Manager)
Prepares presentations and conducts training of Investigators
Ensures team compliance with project-specific training matrix
Performs field training of Monitors tailored to the project needs
Supervises preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits
Oversees investigator and site payments, as well as CRF data retrieval/ upload and monitoring and the query resolution process
Supervises project team preparation for study audits/ inspections and resolution of audit/ inspection findings
Coordinates conduct of supervised monitoring visits
Reviews site visit reports and ensures monitoring and reporting standards are met
Coordinates preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications
Oversees the safety information flow and participates in feasibility research
Reviews/approves project related expenses and timesheets (if delegated by the Project Manager)