Principal Study Start-Up Associate

Principal Study Start-Up Associate – Romania

Location: Bucharest – Hybrid, 1–3 days per week in the office

Employment: Full-time, permanent

About the Role

We are partnering with a leading global clinical research organisation seeking an experienced Senior Study Start-Up Associate to join its team in Romania.

The position will focus on country-level study start-up activities, including regulatory submissions, site activation, clinical trial agreements, budget negotiations and site payments. You will work closely with investigative sites and local study teams to ensure start-up milestones are delivered accurately and on schedule.

Key Responsibilities

• Coordinate and oversee country-level clinical trial submissions and approvals.
• Negotiate and execute Clinical Trial Agreements, site contracts and associated budgets.
• Prepare, review and submit essential regulatory and site documentation.
• Manage site payments throughout the study lifecycle, including payment tracking, issue resolution and close-out reconciliation.
• Work closely with investigative sites and internal study teams to support timely site activation.
• Monitor start-up timelines, identify potential delays and help resolve operational issues.
• Provide guidance on local start-up requirements, processes and best practices.
• Maintain accurate documentation and ensure activities comply with applicable regulations and internal procedures.

Required Experience

• Bachelor’s degree in life sciences, healthcare or another relevant discipline.
• Strong clinical study start-up and site activation experience.
• Practical experience negotiating site contracts and clinical trial budgets.
• Experience managing clinical trial site payments and reconciliation activities.
• Good knowledge of Romanian regulatory and ethics submission requirements.
• Understanding of the documentation and processes required for site activation.
• Strong organisational skills and the ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication skills.
• Fluency in Romanian and English.
• Ability to attend the Bucharest office approximately 1–3 days per week.
• Legal right to work in Romania.

What’s on Offer

• Competitive base salary and performance-related incentives.
• Hybrid working arrangement.
• Health and wellbeing benefits.
• Pension, life assurance and disability coverage, where applicable.
• Employee assistance and wellbeing resources.
• Structured training and long-term career-development opportunities.

Should this opportunity spark some interest, please apply with a copy of your CV to set up a confidential discussion or reach out to olivia@warmanobrien.com.