Principal Study Start-Up Associate

My client is looking to hire a Senior Study Start-Up Specialist in Romania. This is a full-time permanent opportunity with a world-leading CRO.

What You Will Do:

Your focus will be execution and oversight of clinical trial country submissions and approvals and negotiations of budgets and CTAs with sites.

Key responsibilities include:

• Lead the negotiation and execution of Clinical Trial Agreements (CTAs), including site contracts and budget negotiations, ensuring timely study start-up.
• Manage and oversee clinical trial payments throughout the study lifecycle, including payment tracking, issue resolution, and close-out reconciliation.
• Prepare, review, and submit essential regulatory and site documentation to support approvals and successful site activation.
• Partner with local study teams and investigative sites to drive start-up activities and ensure milestones are achieved on schedule.
• Provide expert guidance on study start-up processes, requirements, and best practices, fostering strong collaboration and communication among stakeholders.

Your Profile:

You will have solid site start-up and activation experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• Bachelor's degree in Life Sciences, Healthcare, or a related scientific discipline.
• Comfortable working in a hybrid environment, with the flexibility to attend the office 1–3 days per week.
• Strong knowledge of site budget development, contract negotiations, and local regulatory requirements, including submission and approval processes.
• Proven experience in clinical study start-up activities, with a solid understanding of regulatory frameworks and site activation requirements.
• Experience managing clinical trial site payments and payment reconciliation processes.
• Excellent organizational skills with a strong attention to detail and the ability to manage multiple priorities effectively.
• Strong verbal and written communication skills

For additional information, and a confidential discussion please apply now with an updated CV or contact me directly at trish@warmanobrien.com