Full-Time Clinical Operations Lead
PSI CRO is hiring a remote Full-Time Clinical Operations Lead. The career level for this job opening is Manager and is accepting São Paulo, Brazil based applicants remotely. Read complete job description before applying.
PSI CRO
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Job Details
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, including acting as Regional Lead, Lead monitor, coordinating feasibility and startup processes
- 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