Full-Time Clinical Trials Regional Project Lead

Only CVs in English will be considered

Responsibilities:

1. Coordinating project team work
2. Supervising clinical project team members’ performance
3. Implementation and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents
4. Acting as a point of contact for the project team, PSI support services and contractors
5. Collecting and reporting project status updates
6. Developing and updating project planning documents, essential study documents and project manuals/instructions
7. Conducting and supervising therapeutic area training of the project team and Investigators
8. Supervising preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits and reviewing site visit reports
9. Overseeing investigator and site payments
10. Supervising project team preparation for study audits/inspections and resolution of audit/inspection findings
11. Coordinating preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications
12. Performing 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 Portuguese and English
• At least 4 years’ experience in a healthcare 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

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