Clinical Study Assistant

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

📋 Description

• Execute responsibilities associated with the design and implementation of clinical studies as a Clinical Study Assistant dedicated to a Pharmaceutical Company.

• Assist with essential daily clinical study operations, including preparation for regulatory inspections, under the general guidance of the FSP Manager and in cooperation with CTA Managers.

• Partner with Clinical Operations/Study Managers, study teams, and CROs.

• Carry out departmental tasks as necessary.

• Evaluate study documentation, including essential document packets, study plans, and informed consent forms.

• Aid or supervise risk-based monitoring.

• Attend important team meetings and draft minutes for selected studies.

• Assist with regulatory inspection readiness, including compiling SOP lists and storyboards.

• Contribute to clinical trial systems such as CTMS/TMF and related activities.

• Assist with vendor contract management.

• Support study close-out activities, including financial reconciliation.

• Help with additional ad-hoc tasks as agreed with managers.

• Collaborate with Legal, Insurance, R&D functions, CROs, and external vendors.

⛳️ Requirements

• A Bachelor’s degree in a scientific or healthcare-related discipline or an equivalent international qualification is required.

• 1-2 years of experience in the pharmaceutical industry, a clinical research organization, or a similar role.

• Experience in Phase 2 and 3 studies, along with global/international studies, is a plus.

• Background in multiple therapeutic areas (including oncology) is advantageous.

• Familiarity with global/regional regulatory and compliance standards for clinical research.

• Proven excellence in task management and cross-functional collaboration.

• Strong communication skills.

• Exceptional teamwork, organizational, interpersonal, and problem-solving abilities.

• Proficient in business English, both spoken and written.

• Capability to work collaboratively in a dynamic environment while maintaining attention to detail.

• Willingness to travel as needed (approximately 10%).

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary with performance-related bonuses.

• Health and wellness programs, including medical, dental, and vision coverage when applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.