Senior Clinical Research Associate Medical Devices (Freelance)

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 Research Associate is responsible for monitoring and managing sites based in Portugal.

Please keep in mind that this is a Freelance role for only 0.2 FTE.

As part of our SRS/FSP 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

• Independently plan conduct and follow up on pre-study site initiation routine monitoring and close-out visits both on-site and remotely in line with the applicable monitoring plan

• Oversee study site performance including recruitment progress and provide ongoing support to sites on study-related questions and operational issues

• Review eCRF data timelines and queries; identify and report protocol deviations; and maintain clear communication with project management and sponsors

• Review and maintain study documentation at site level including Investigator Site Files (ISF) ensuring inspection readiness and compliance with applicable regulations

• Collaborate cross-functionally with medical project management quality management and data management teams and support sites during audits and inspections

Qualifications

• Degree in a scientific or medical discipline or completed vocational training in a relevant healthcare or medical field

• Additional training in clinical research or CRA certification combined with several years of experience as a Clinical Research Associate

• Strong knowledge of GCP ICH guidelines and clinical research processes with a high level of accuracy in handling study data and regulatory requirements

• Fluent Portugese and English language skills both written and spoken with willingness to travel nationally and internationally as required

• Must Have: Extensive experience in Medical Device studies and ISO14155 knowledge.

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.