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
maintain the Study Master File (SMF) and coordinate practical tasks
during the study according to company policies, SOPs and regulatory
requirements. As part of our SRS/FSP team, you will be dedicated to
one sponsor, a integral 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 ma

📌 Clinical Trial Associate (Madrid)
🏢 TFS HealthScience
📍 Madrid