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Clinical Trials Regional Project Manager
hace 2 meses
Job Summary:
We are seeking a highly skilled and experienced Clinical Trials Regional Project Lead to join our team at PSI. As a key member of our Clinical Operations department, you will be responsible for coordinating project activities, ensuring milestones are met, and maintaining consistency of Clinical Operations processes across regions.
Key Responsibilities:
- Coordinate project team work and supervise the performance of clinical project team members.
- Implement and manage projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents.
- Act as a point of contact for the project team, PSI support services, and contractors.
- Collect and report project status updates.
- Develop and update project planning documents, essential study documents, and project manuals/instructions.
- Conduct and supervise therapeutic area training of the project team and Investigators.
- Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits, and review site visit reports.
- Oversee investigator and site payments.
- Supervise project team preparation for study audits/inspections and resolution of audit/inspection findings.
- Coordinate preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications.
- Perform other project management tasks in agreement with the responsible Clinical Operations Manager following adequate and documented training and formal delegation of tasks.
Qualifications:
- College/University degree in Life Sciences or an equivalent combination of education, training & experience.
- Full working proficiency in Spanish and English.
- At least 4 years' experience in a health care or clinical environment.
- Minimum 4 years' site monitoring experience and at least 2 years' experience as Lead Monitor or equivalent.
- Availability to travel.
- Proficiency in MS Office applications.
- Ability to plan and work in a dynamic team environment.
- Communication, collaboration, and problem-solving skills.