Descripción de la oferta
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 Clinical Trial Associate is responsible for organizing and
maintaining the Study Master File (SMF) and coordinate practical
tasks during the study according to company policies, SOPs and
regulatory requirements. As part of our Functional Solutions 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 Work with the Study Team in
initiating, maintaining and closing/final archiving of the SMF,
ensuring GCP compliance. Set up and maintenance of study
information in Clinical Trial Management System (CTMS) as per
delegation from PM/ Lead CRA or CRA. Maintenance of electronic
files. Set up the Investigator’s File as directed by the CRA. Point
of contact regarding SMF. Maintain the SMF as directed by the Lead
CRA/Project Manager. Coordinate study supplies as directed by the
CRA. Drafts and/or assists with the preparation of trial-related
documents, tools and templates. Assist in status reporting. Arrange
internal and external meetings. Actively taking part in Study Team
meetings and be responsible for the minutes. Prepare, contribute to
and distribute presentation material for meetings and newsletter.
Assist in activities associated with audits and regulatory
inspections. SMF completion and preparation of shipment to sponsor
as directed by the Lead CRA/CRA. Collection of appendices for final
Clinical Study report. Actively contribute to the organization and
development of routines to enhance the work at TFS Work with the
Study Team in all regulatory process (IEC/IRBs/CA ) including
submission and amendments, regulatory fees. Assist the CRA, PM or
Lead CRA managing contracts with sites, including contract status.
To manage Investigator Payments as directed by PL or Lead CRA.
Assist the PL with document translations process. May support the
CRAs with some monitoring remote activities: collection of
documentation, follow up on data entry, queries resolution.
Qualifications Bachelor’s Degree preferred Knowledge of GCP/ICH
guidelines Good written and communication skills Good
organizational skills Good software and computer skills Able to
work in a fast paced environment 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. Securing the Path from Science to Life
