Study Start-Up Specialist

STUDY START-UP SPECIALIST
HYBRID - BARCELONA (3 days/week working at the office)

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 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 to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness prior to setting sites ready to enrol and in line with company SOPs.

Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.

. Etc

Qualifications

Bachelor degree in related discipline preferably in life science or equivalent qualification.

Previous experience working in a pharmaceutical/biotech company in SSU or related position.

Good knowledge of international guidelines ICH-GCP as well as relevant local regulations basic knowledge of GMP/GDP

Basic understanding of drug development process

Good collaboration and interpersonal skills.

Good verbal and written communication skills.

Excellent attention to details.

Excellent understanding of Clinical Study Management and study start-up

Good negotiation skills.

Good ability to learn and to adapt to work with IT systems.

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.