Project Specialist

This is a fully remote position, open to applicants in Romania.

📋 Description

• Play a vital role within the sponsor's Global Study Team by ensuring the clinical study is delivered on schedule, within budget, and meets quality standards.

• Guarantee inspection readiness by overseeing the completeness of the study eTMF.

• Manage the budget, including handling Task/Change Orders, monitoring expenses, tracking updates, ensuring consistency across systems and agreements, and escalating issues to the Project Manager.

• Provide country oversight and serve as the primary contact point.

• Monitor recruitment progress, data completeness, and compliance, while also overseeing local budgets, protocol deviations, risks, regulatory approvals, and the status of import licenses.

• Manage vendors and provide oversight for CROs, acting as the main point of contact and ensuring the delivery of study-specific outputs.

• Oversee data management, focusing on the completeness of the eTMF, which includes eTMF setup, periodic reviews, following up on missing documents, and disseminating Safety Reports.

• Maintain relationships and conduct meetings with both internal and external stakeholders.

• Review key clinical documents and lead the creation of study plans for both external and internal stakeholders.

• Track study conduct and progress, identifying, resolving, and escalating any risks or issues that arise.

• Establish and maintain systems and tracking tools that ensure the quality, consistency, and integration of study data, addressing discrepancies as necessary.

⛳️ Requirements

• Degree in Life Sciences.

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

• Experience in global project management or supporting cross-functional teams at the study level is preferred.

• Familiarity with eTMF and CTMS is required.

• Proficiency in English.

• Strong skills in Microsoft Office applications (Excel, PowerPoint, Word, Outlook, etc.).

• Advanced Excel skills, along with knowledge of timelines, budget tracking systems, and clinical trial management systems, are advantageous.

• Exceptional stakeholder management and communication abilities (both oral and written), along with outstanding interpersonal skills.

🏝️ Benefits

• Competitive base salary along with performance-based incentives.

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

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

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