Sponsor Dedicated Site Startup Lead remote in Europe

Munich - Germany

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

At Fortrea we believe in improving lives through the power of science collaboration and innovation. As a global CRO partner we support mission-driven sponsors in bringing new therapies to the patients who need them.

Were now hiring a Study Start-Up Lead to join a sponsordedicated team and drive the successful planning and activation of clinical trials. If you are passionate about accelerating study timelines using data to guide decisions and mentoring study start-up teams this role offers you the opportunity to create a real impact.

Why join Fortrea

Work in a collaborative global environment with experts passionate about improving clinical research.
Influence data-driven study start-up strategies for large-scale international programs.
Play a key role in optimizing processes bringing fresh ideas and driving continuous improvement.
Benefit from flexible European locations and the stability of a sponsor-dedicated model.

Your Main Responsibilities

In this role you will lead guide and empower site activation teams across multiple that respect your main responsibilities will be as follows:

EU-CTR Submission Management: Handle initial substantial non-substantial additional submissions and member state coordination.
Document Oversight: Ensure timely collection of submission documents from SSU Specialists across countries.
Meeting Coordination: Organize and manage Teams meetings for SSU Specialists.
CRO Collaboration: For CRO-involved countries maintain regular contact with the CRO Lead assist with issue resolution address questions from CRO Specialists and connect them with Clinical Operations.
ICF Management: Monitor progress review updates and maintain oversight of Informed Consent Forms for all EU-CTR countries.
Quality Control: Perform QC checks for all site documents on SharePoint and in CTIS.
Process Development: Support the setup of new SSU processes and SOPs; contribute ideas and create training materials and presentations.

What You Bring

Bachelors degree in Life Sciences (or international equivalent).
4 years of experience in clinical submission processes and optimization and site activation management within a sponsor or CRO environment.
Proven experience with country-level ICF creation.
Strong proficiency with data models forecasting tools and database structures.
Experience working in site start-up on a regional level strongly preferred.
Ability to explain complex data clearly and support data-driven decision-making.
Expert understanding of factors that drive successful study start-up and site selection strategies.

Where You Can Be Based

This is a European role and applicants may be based in:
Poland Germany Spain United Kingdom Sweden France Bulgaria Netherlands or Romania.

Ready to make an impact

Join Fortrea and play a key role in bringing new therapies to patients faster.
Apply today and help shape the future of clinical research.

Learn more about our EEO & Accommodations request here.

At Fortrea we believe in improving lives through the power of science collaboration and innovation. As a global CRO partner we support mission-driven sponsors in bringing new therapies to the patients who need them.Were now hiring a Study Start-Up Lead to join a sponsordedicated team and drive the s...

Why join Fortrea

Work in a collaborative global environment with experts passionate about improving clinical research.
Influence data-driven study start-up strategies for large-scale international programs.
Play a key role in optimizing processes bringing fresh ideas and driving continuous improvement.
Benefit from flexible European locations and the stability of a sponsor-dedicated model.

Your Main Responsibilities

In this role you will lead guide and empower site activation teams across multiple that respect your main responsibilities will be as follows:

EU-CTR Submission Management: Handle initial substantial non-substantial additional submissions and member state coordination.
Document Oversight: Ensure timely collection of submission documents from SSU Specialists across countries.
Meeting Coordination: Organize and manage Teams meetings for SSU Specialists.
CRO Collaboration: For CRO-involved countries maintain regular contact with the CRO Lead assist with issue resolution address questions from CRO Specialists and connect them with Clinical Operations.
ICF Management: Monitor progress review updates and maintain oversight of Informed Consent Forms for all EU-CTR countries.
Quality Control: Perform QC checks for all site documents on SharePoint and in CTIS.
Process Development: Support the setup of new SSU processes and SOPs; contribute ideas and create training materials and presentations.

What You Bring

Bachelors degree in Life Sciences (or international equivalent).
4 years of experience in clinical submission processes and optimization and site activation management within a sponsor or CRO environment.
Proven experience with country-level ICF creation.
Strong proficiency with data models forecasting tools and database structures.
Experience working in site start-up on a regional level strongly preferred.
Ability to explain complex data clearly and support data-driven decision-making.
Expert understanding of factors that drive successful study start-up and site selection strategies.