Regional Project Lead

vor 2 Monaten

Zug, Zug, Schweiz PSI Vollzeit
Job Description

The Regional Project Lead plays a critical role in managing and coordinating project activities across designated countries, ensuring consistency of Clinical Operations processes and meeting study milestones.

Key Responsibilities
  • Develop and implement project plans in compliance with industry regulations, ICH-GCP, and essential study documents.
  • Act as primary or secondary project management contact for the project team and PSI support services in designated countries.
  • Perform study status reviews and progress reporting, collecting and reporting project status updates for designated regions.
  • Develop and update project planning documents, essential study documents, and project manuals/instructions.
  • Manage and report on Key Performance Indicators (KPIs) for designated countries and clinical project team members.
  • Ensure project timelines and subject enrollment targets are met in designated countries.
  • Coordinate maintenance of study-specific and corporate tracking systems.
  • Coordinate site contractual startup and budget negotiations.
  • Establish communication lines within the project team and supervise clinical project team members' performance.
  • Identify, escalate, and resolve resourcing and performance issues.
  • Conduct and supervise therapeutic area training of the project team.
  • Prepare presentations and conduct training of Investigators.
  • Ensure team compliance with project-specific training matrix.
  • Perform field training of Monitors tailored to the project needs.
  • Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits.
  • Oversee investigator and site payments, as well as CRF data retrieval/upload and monitoring and the query resolution process.
  • Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings.
  • Coordinate conduct of supervised monitoring visits.
  • Review site visit reports and ensure monitoring and reporting standards are met.
  • Coordinate preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications.
  • Oversee the safety information flow and participate in feasibility research.
  • Review/approve project-related expenses and timesheets.
Qualifications
  • College/University degree in Life Sciences or an equivalent combination of education, training & 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.
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.

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