Regional Project Lead

The official title for this role will be Regional Project Lead.

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.

• Ensures planning implementation and management of projects in compliance with industry regulations ICHGCP 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 studyspecific 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 projectspecific 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 followup 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
• At least 4 years of experience in Clinical Research and site monitoring activities
• At least 2 years of expereince 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 customerservice skills
• Ability to negotiate and build relationships at all levels
• Teambuilding leadership and organizational skills

Additional Information :

Advance your career in clinical research and lead challenging fullservice projects on the country/regional level while growing with a rapid company that puts its people first! You will get handson involvement in every aspect of the study.

Remote Work :

Yes

Employment Type :

Fulltime