Start Up Lead - Sponsor-dedicated

Fortrea; Deutschland; Hybrid; EUR 70.000 - 105.000; Vollzeit

Zusammenfassung

Fortrea, a global CRO, is hiring a Study Start-Up Lead to drive planning and activation of clinical trials across multiple countries. You will lead site activation, coordinate submissions, ensure documentation, and collaborate with CROs and internal teams to accelerate timelines.

The role emphasizes data-driven decision making, mentoring SSU teams, and developing new SSU processes. Fortrea offers flexible European locations and a sponsor-dedicated model.

Qualifikationen

• Bachelor’s degree in Life Sciences (or international equivalent).
• 4+ years of experience in clinical submission processes and site activation management.
• 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 is 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.

Aufgaben

• 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: liaise with the CRO Lead, assist with issue resolution, address CRO Specialist questions, and connect them to Clinical Operations.
• ICF management: monitor progress, review updates, and oversee Informed Consent Forms for all EU-CTR countries.
• Quality control: perform QC checks for site documents on SharePoint and in CTIS.
• Process development: support setup of new SSU processes and SOPs; contribute ideas and create training materials and presentations.

Kenntnisse

Data models

Forecasting tools

Database structures

Data-driven decisions

Ausbildung

Bachelor’s degree in Life Sciences

Jobbeschreibung

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.

We’re now hiring a Study Start-Up Lead to join a sponsor‑dedicated 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 countries. In 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

• Bachelor’s 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.

Ready to make an impact?

Join Fortrea and play a key role in bringing new therapies to patients faster.

Learn more about our EEO & Accommodations request here.