Project Specialist – Sponsor Dedicated

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Establish, oversee, and/or finalize project files and study data, which includes regulatory documents, Trial Master File, enrollment, Adverse Events/Serious Adverse Events, site supplies, Institutional Review Board re-approvals, and data inquiries, utilizing databases and systems.

• Participate in, prepare, and distribute meeting notes and action items for both internal and external meetings.

• Follow up with team members to ensure the completion of action items.

• Maintain prompt and effective communication among team members and site personnel.

• Keep Project Leadership and Clinical Research Associates fully updated on site and study progress.

• Reach out to site staff as necessary for crucial information.

• Provide administrative assistance to Project Leads and functional leads.

• Ensure that study documents are archived in accordance with relevant guidelines and policies.

• Assist with quality assurance initiatives, including preparation for audits and internal reviews, documentation, and resolution of actionable issues.

⛳️ Requirements

• An Associate's Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a related field, or a comparable combination of education and experience.

• Familiarity with Good Clinical Practice/ICH guidelines and other relevant regulatory standards.

• Strong organizational capabilities.

• Ability to manage time effectively and work independently.

• High proficiency in all MS Office Applications.

• Excellent communication, presentation, and interpersonal skills, both written and verbal, with the ability to inform, influence, persuade, and convince others.

• Willingness to travel if necessary (approximately 5%) to Syneos and/or client locations is preferred.

• High level of proficiency in the English language.

• Knowledge of Portuguese or French will be highly regarded.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations, when appropriate.