Clinical Trial Associate

TFS; 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

About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.

The Clinical Trial Associate is responsible for organizing and maintaining the Study Master File (SMF) and coordinate practical tasks during the study according to company policies, SOPs and regulatory requirements.

As part of our Functional Solutions team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.

Key Responsibilities

• Work with the Study Team in initiating, maintaining and closing/final archiving of the SMF, ensuring GCP compliance.

• Set up and maintenance of study information in Clinical Trial Management System (CTMS) as per delegation from PM/ Lead CRA or CRA.

• Maintenance of electronic files.

• Set up the Investigator’s File as directed by the CRA.

• Point of contact regarding SMF.

• Maintain the SMF as directed by the Lead CRA/Project Manager.

• Coordinate study supplies as directed by the CRA.

• Drafts and/or assists with the preparation of trial-related documents, tools and templates.

• Assist in status reporting.

• Arrange internal and external meetings.

• Actively taking part in Study Team meetings and be responsible for the minutes.

• Prepare, contribute to and distribute presentation material for meetings and newsletter.

• Assist in activities associated with audits and regulatory inspections.

• SMF completion and preparation of shipment to sponsor as directed by the Lead CRA/CRA.

• Collection of appendices for final Clinical Study report.

• Actively contribute to the organization and development of routines to enhance the work at TFS.

• Work with the Study Team in all regulatory process (IEC/IRBs/CA ) including submission and amendments, regulatory fees.

• Assist the CRA, PM or Lead CRA managing contracts with sites, including contract status.

• To manage Investigator Payments as directed by PL or Lead CRA.

• Assist the PL with document translations process.

• May support the CRAs with some monitoring remote activities: collection of documentation, follow up on data entry, queries resolution.

Qualifications

• Bachelor’s Degree preferred

• Knowledge of GCP/ICH guidelines

• Good written and communication skills

• Good organizational skills

• Good software and computer skills

• Able to work in a fast paced environment with changing priorities

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Securing the Path from Science to Life