SeniorFull TimeEN
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 Stockholm, Sweden.
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 Swedish 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.
