Senior Clinical Trial Associate

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.

As a Clinical Trial Associate you will play a key role in supporting clinical studies from start-up to close-out. You will ensure compliance accuracy and efficiency in study documentation and coordination. Working closely with the Project Manager Lead CRA and Study Team you will help drive operational excellence across all phases of the clinical trial.

As part of our SRS/FSP team you will be dedicated to one sponsor a Big Pharma company.

Please keep in mind that this is a hybrid role with 3 days per week working from an office in Luton.

Key Responsibilities

• Organize maintain and archive the Study Master File (SMF) in accordance with GCP SOPs and regulatory requirements.
• Support study setup and maintenance in the Clinical Trial Management System (CTMS).
• Prepare and manage Investigators Files and coordinate study supplies.
• Prepare and distribute trial-related documents tools and templates.
• Arrange and document internal and external meetings including taking meeting minutes.
• Assist with audits and regulatory inspections.
• Assist with site contracts investigator payments and translation processes.
• Act as Lead CTA or mentor to junior team members when assigned.

Qualifications:

• Bachelors degree preferred.
• 35 years of relevant experience including at least 3 years as a CTA.
• Strong knowledge of GCP/ICH guidelines.
• Excellent written and verbal communication skills.
• Highly organized with strong attention to detail and the ability to manage multiple priorities.
• Proficient in Microsoft Office and relevant clinical systems.
  

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden in the city of Lund. As a full-service global Contract Research Organization (CRO) we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.

Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.