Clinical Operations Lead

Company Description

PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

Clinical Operations Lead is focused on line management and mentoring of Monitors on project-specific activities, according to assignments from the Monitors’ Line Manager. This function operates at a country level and may be assigned to more than one country of operation.

Only CVs in English will be considered

The scope of responsibilities will include:

• Line management activities for the Clinical Operations team, acting as a mentor for the monitors on project-specific activities and supporting their professional development.
• Project management tasks if required, including acting as Regional Lead, Lead monitor, coordinating feasibility and startup processes, etc.
• Builds and maintains good relationships with sites’ staff involved in the study conduct.
• Support coordination of resource allocation to projects and utilization monitoring.
• Oversight of the staff workload, performance appraisal, and career advancement.
• Supervises activities of Site Management Associates related to the flow of documents and laboratory supplies between the site and the Central/Regional Laboratory/Central Reviewer.
• Training, coaching, and mentoring the team.
• Ensuring compliance with GCP standards and internal/external procedures.
• Development and implementation of quality control.
• Ensuring data integrity and compliance at a site level.
• Ensures proper handling, accountability, and reconciliation of all Investigational Product(s) and clinical study supplies.
• Regional project oversight.
• Maintenance, revision, and establishment of processes on the regional level.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience.
• Full working proficiency in Portuguese and English.
• At least 4 years’ experience in a health care or clinical environment.
• Minimum 4 years’ site monitoring experience.
• Ability to successfully mentor and train Clinical Operations staff.
• Availability to travel.
• Proficiency in MS Office applications.
• Ability to plan and work in a dynamic team environment.
• Communication, collaboration, and problem-solving skills.

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.