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 Senior Clinical Trial Associate is responsible for coordinating and maintaining study documentation and supporting clinical trial operations to ensure compliance with ICH GCP, SOPs, and regulatory requirements. You will play a key role in supporting the study team across all phases of the trial, from start-up through close-out.

As part of our SRS FSP team, you will be dedicated to one sponsor and support the execution of a Phase 2 clinical study within cardiology.

Key Responsibilities

• Set up, maintain, and close the Study Master File, ensuring completeness and compliance with GCP requirements

• Maintain and update study information in CTMS in collaboration with CRAs and Project Manager

• Support study start-up, maintenance, and close-out activities across sites and countries

• Assist with preparation and coordination of regulatory submissions, amendments, and essential documents

• Act as point of contact for study documentation and support audit and inspection readiness

• Organize internal and external meetings, including preparation of materials and meeting minutes

• Support contract tracking and investigator payments in collaboration with study team

• Assist with preparation of study reports, presentations, and newsletters

• Contribute to process improvements and support onboarding or mentoring of junior team members when applicable

Qualifications

• Bachelor’s degree in life sciences or related field preferred

• Minimum 3 years of experience as a Clinical Trial Associate

• Strong knowledge of ICH GCP and clinical trial processes

• Experience with CTMS and Trial Master File management

• Experience supporting regulatory submissions and study documentation

• Ability to work independently and collaboratively in a matrix environment

• Comfortable working in a fast-paced setting 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.