Clinical Trial Manager

Local Clinical Trial Manager / Local Study Associate Director

Location: Bucharest, Romania (Hybrid)

Employment Type: Full-time

About the Role

We are seeking an experienced Local Clinical Trial Manager (LCTM) / Local Study Associate Director to join a global Clinical Operations team based in Bucharest. This is a hybrid position, with an expectation of working from the office approximately 1–3 days per week.

In this role, you will be responsible for the successful planning, start-up, and execution of clinical trials within Romania. As the local study lead, you will oversee operational delivery, collaborate with internal and external stakeholders, and ensure studies are conducted in accordance with regulatory requirements, timelines, and quality standards.

Key Responsibilities

• Lead local study management activities for clinical trials conducted in Romania.
• Plan and coordinate study start-up activities, ensuring milestones are achieved within agreed timelines.
• Support site selection and preparation for patient enrolment.
• Drive and support patient recruitment by working closely with study sites and acting as the local clinical trial expert.
• Oversee local study start-up activities and monitor study progress to ensure timelines and deliverables are met.
• Manage local study budgets and provide financial oversight throughout the study lifecycle.
• Review Clinical Research Associate (CRA) monitoring visit reports to ensure quality and compliance.
• Participate in Accompanied Site Visits (ASVs) alongside CRAs to support site performance and quality oversight.
• Provide operational leadership and project management to the assigned local study team, including Clinical Research Associates (CRAs) and Clinical Trial Associates (CTAs).
• Collaborate with global study teams, investigators, vendors, and cross-functional stakeholders to ensure successful study execution.
• Identify operational risks and implement appropriate mitigation strategies.
• Ensure all study activities comply with ICH-GCP guidelines, local regulations, and company SOPs.

Essential Qualifications

• Previous experience in Clinical Study Management, Local Trial Management, or a similar clinical operations leadership role.
• Strong understanding of the clinical trial lifecycle, including study start-up, patient recruitment, monitoring, and close-out.
• Experience coordinating or leading cross-functional clinical trial teams.
• Knowledge of ICH-GCP guidelines and local regulatory requirements.
• Strong project management, planning, and organisational skills.
• Excellent communication and stakeholder management abilities.
• Experience managing local study budgets is desirable.
• Fluency in English and Romanian.
• Must be based in or within commuting distance of Bucharest.

Preferred Qualifications

• Experience working within a pharmaceutical company or CRO.
• Experience managing multiple clinical studies simultaneously.
• Strong understanding of local clinical trial regulations and site management.
• Experience supporting complex, multinational clinical trials is an advantage.

What's on Offer

• A key leadership role within a global clinical operations environment.
• Opportunity to contribute to innovative clinical research programmes.
• Hybrid working model, typically requiring 1–3 days per week in the Bucharest office.
• A collaborative, international working environment.
• Excellent opportunities for professional growth and career development.
• Competitive salary and benefits package.

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.