Clinical Trial Associate – SMF Mastery & Study Ops

TFS HealthScience; Bellprat; On-site; EUR 45,000 - 60,000; Full time

Job summary

TFS HealthScience is seeking a Clinical Trial Associate to organize and maintain the Study Master File (SMF) and coordinate practical tasks across studies in compliance with SOPs and regulations.

Ideal candidates hold a Bachelor’s degree (preferred) and have knowledge of GCP/ICH, strong communication, and solid organizational and IT skills to support study management and regulatory activities.

Qualifications

• GCP/ICH guidelines knowledge required.
• Strong written and verbal communication skills.
• Good organizational skills and attention to detail.
• Proficient software and computer skills.
• Ability to work in a fast-paced environment with changing priorities.

Responsibilities

• Organize and maintain the Study Master File (SMF) and coordinate tasks.
• Support study initiation, maintenance and archiving per SOPs and regulatory requirements.
• Assist with CTMS data entry and study information management.
• Prepare and maintain study-related documents and templates.
• Support audits and regulatory inspections preparation.
• Coordinate meetings and distribute minutes and materials.
• Assist in status reporting and contract tracking with sites.
• Contribute to process improvements within the study team.

Skills

GCP/ICH guidelines

Written communication

Organizational skills

Software/computer skills

Adaptability

Education

Bachelor’s Degree preferred

Job description

TFS HealthScience is seeking a Clinical Trial Associate to organize and maintain the Study Master File (SMF) and coordinate practical tasks across studies in compliance with SOPs and regulations.

Ideal candidates hold a Bachelor’s degree (preferred) and have knowledge of GCP/ICH, strong communication, and solid organizational and IT skills to support study management and regulatory activities.