Lead Clinical Research Associate

TFS HealthScience; Paris; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A global clinical research organization is seeking a Lead Clinical Research Associate to support project management and ensure compliance with monitoring activities. The ideal candidate has a Bachelor’s Degree in life sciences and a minimum of 3 years of CRA experience, with a focus on site management and oversight. The role includes excellent communication and organizational skills, with some travel required. Enjoy competitive compensation and benefits, and join a team committed to making a difference in patients' lives.

Prestations

Competitive compensation package

Comprehensive benefits

Opportunities for personal and professional growth

Qualifications

• Minimum 3 years of experience as CRA including relevant on-site monitoring experience.
• Possess understanding of Good Clinical Practice regulations, ICH guidelines.
• Ability to travel up to 10-20%.

Responsabilités

• Oversee all aspects of monitoring and site management activities.
• Train and provide quality oversight of site management activities.
• Develop monitoring plans and coordinate study meetings.

Connaissances

Fast-paced environment adaptability

Understanding of medical terminology

Excellent written and verbal communication

Independent and team collaboration

Organizational and Line Management

Formation

Bachelor’s Degree in life science or nursing

Description du poste

Join Our Team as a Lead Clinical Research Associate

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.

About this role

As part of our Strategic Resourcing Solutions (SRS) team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

Key Responsibilities

• Support the Project Manager being responsible and accountable for overseeing all aspects of monitoring and site Management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements.
• Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables.
• Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.
• Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.
• Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.
• Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.
• ...

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent.
• Minimum 3 years of experience as CRA including relevant on‑site monitoring experience.
• Able to work in a fast‑paced environment with changing priorities.
• Understand the basic medical terminology and science associated with the assigned drugs and therapeutic areas.
• Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
• Ability to work independently as well as in a team matrix organization and multiple projects.
• Excellent written and verbal communication skills as well as computer skills.
• Excellent organizational and Line Management skills.
• Ability and willingness to travel up to 10‑20%

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll 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 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well‑being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East.

Our core values of Trust, Quality, Flexibility and Passion are what make TFS HealthScience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization.

Together we make a difference