Country Approval Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7c8xnm

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you’ll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.

What You’ll Do:
OBJECTIVES/PURPOSE
Supporting the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.
Support sites and study teams to achieve rapid site start up.
ACCOUNTABILITIES
Work directly with assigned sites on all site related essential document collection and review.




Partner with internal Study Startup team, CROs, Clinical Operations teams, and partners to improve overall SSU metrics and deliver processes.
Ensure standards are applied to the SSU processes across projects.
Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
Promptly recognize and improve potential site activation delays and escalate to appropriate team members.
Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
Review and provide feedback to management on site performance metrics.
Ensure accuracy and completeness of the eTMF for assigned sites during start up
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Understanding of the pharmaceutical industry (e.g., clini

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7c8xnm