Clinical Trial Manager

Summary

Join PSI, a dynamic global company, as a Regional Project Lead and manage and coordinate project teams across designated countries. Ensure consistency in Clinical Operations processes, meeting study milestones, and compliance with regulations. Act as a primary contact for project teams and support services, performing study status reviews and reporting. Develop and update project documents, manage KPIs, and ensure project timelines and enrollment targets are met. Coordinate site startup, budget negotiations, and communication within the project team. Identify and resolve issues, conduct training, and supervise project team members' performance. Oversee various aspects of study execution, including monitoring visits, payments, data retrieval, and audit preparation. Coordinate regulatory submissions and safety information flow.

Requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• At least 4 years of experience in Clinical Research and site monitoring activities
• At least 2 years of experience as a Study Manager or Lead with the ability to supervise project activities as a Regional Lead or equivalent
• 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

Responsibilities

• Manages and coordinates activities of project teams in designated countries and ensures consistency of Clinical Operations processes across regions
• Ensures 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)

Preferred Qualifications

Experience in Oncology is preferred