Regional Operations Manager
Vor 4 Tagen
Job Overview
The Regional Project Lead at PSI is responsible for managing and coordinating project activities across designated countries, ensuring consistency of Clinical Operations processes and meeting study milestones.
Key Responsibilities
- Ensures project planning, implementation, and management are in compliance with industry regulations, ICH-GCP, and applicable controlled documents.
- Acts as primary or secondary project management contact for project teams 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 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 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 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, and experience.
- Significant experience in Clinical Research and site monitoring.
- Experience as a Study Manager or Lead with the ability to supervise project activities as a Regional Lead or equivalent.
- Experience in Oncology 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.
About PSI
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.
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