Company Description
PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Job Description
The Regional Project Lead is a senior level clinical trial manager who oversees, 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.
- 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)
Qualifications
- 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
- Prior experience monitoring within the US
- 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
- Experience in GI is preferred
- 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
Additional Information
Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study.
