Clinical Regional Project Lead

Psicro; Comisión de Fomento de Perú; Sur place; ARS 136 310 000 - 227 183 000; Plein temps

Résumé du poste

Psicro seeks a Regional Project Lead to coordinate clinical operations across designated regions. You will oversee project teams, ensure milestones, manage site initiation and monitoring activities, and uphold regulatory standards across trials.

The role requires a life sciences background, strong English, and proven leadership in clinical research with on-site monitoring experience, including work in the US market.

Qualifications

• College/University degree in Life Sciences.
• Experience in Clinical Research and on-site monitoring.
• Experience monitoring within the US.
• Full working proficiency in English.
• Proficiency in MS Office and MS Project.
• Strong communication, leadership and stakeholder skills.

Responsabilités

• Oversee multinational project teams to ensure regional delivery.
• Manage site initiation, monitoring visits, and closeout activities.
• Maintain study documents, budgets and timelines.
• Coordinate regulatory submissions and ethics approvals.
• Report KPIs and performance to project management.
• Build relationships with investigators and sponsors.

Connaissances

Life Sciences

English Proficiency

MS Office

MS Project

Communication Skills

Leadership

Stakeholder Management

Formation

Bachelor's degree in Life Sciences

Outils

MS Office Suite

MS Project

Description du poste

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.

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)

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
• 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

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.