STUDY START-UP SPECIALIST HYBRID - BARCELONA (3
days/week working at the office) About this role TFS HealthScience
is a leading general 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 Study Start-Up Specialist is
responsible at country level for managing and conducting start-up
activities in compliance with the company procedures, documents,
local and international guidelines such as ICH – GCP and relevant
regulations. The SSU Specialist will prepare, review, track and
manage site regulatory documentation at country and site level, and
will maintain, review and report on site performance metrics. The
SSU manager works in close collaboration with the CRAs and the
Local Study Team/Local Study Associate Director to ensure that
study start-up activities and milestones are achieved in a timely
and efficient manner. Key Responsibilities ( Summarized but Not
Limited To)



· Contribute to ensure that clinical and operational
feasibility assessment of potential studies is performed to the
highest quality. · Accountable for study start-up and regulatory
maintenance being in charge with collection, preparation, review
and tracking of documents for the application process; ·
Accountable for submission of proper application/documents to
Regulatory Authorities and/or IEC/IRB during start-up period. ·
Actively participates in Local Study Team (LST) meetings. · Update
CTMS and other systems with data from study sites as per required
timelines during the start-up period. · Follow up on outstanding
actions with study sites during start-up period to ensure
resolution in a timely manner. · Ensure timely collection/uploading
of essential documents into the eTMF in accordance with ICH-GCP,
company SOPs and local requirements. Support QC checks performed by
LSAD or delegate t

📌 Study Start-Up Specialist (Cataluña)
🏢 TFS HealthScience
📍 Cataluña