Project Specialist

This is a fully remote position, open to applicants in Romania, +2 more countries.

📋 Description

• Assist global project managers across EMEA, APAC, and the US.

• Collaborate remotely as a key member of the sponsor’s international study team.

• Oversee budget management, including handling Task/Change Orders, monitoring expenses, tracking updates, ensuring system/agreement consistency, and escalating issues as necessary.

• Monitor recruitment progress, data completeness and compliance, local budgets, protocol deviations, risks, regulatory approvals, and import license status.

• Act as the primary liaison for vendors and supervise study-specific deliverables and delegated tasks.

• Ensure eTMF completeness.

• Maintain regular interactions and meetings with both internal and external stakeholders.

• Review essential clinical documents, such as Protocol and Informed Consent Forms.

• Lead the development of study plans for assigned projects.

• Supervise study execution and progress, identifying, resolving, and escalating risks and issues.

• Establish and maintain systems and tracking tools to ensure quality, consistency, and integration of study data.

• Address discrepancies and grant access to new users of the system.

⛳️ Requirements

• Degree in Life Sciences.

• Minimum of 1 year of clinical trial experience in clinical research.

• Availability to commence work within a maximum of 1 - 2 months.

• Experience in global project management or supporting cross-functional teams at the study level would be advantageous.

• Familiarity with eTMF and CTMS.

• Proficiency in English.

• Strong understanding of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.).

• Knowledge of advanced Excel, timeline/budget tracking systems, and clinical trial management systems is beneficial.

• Excellent skills in stakeholder management and communication (both oral and written).

• Exceptional interpersonal skills.

• Legal eligibility to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.