Site Management Associate

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

📋 Description

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

• Work remotely as a member of the sponsor's global study team.

• Aid in the timely, cost-effective, and high-quality delivery of clinical studies, ensuring inspection readiness through oversight of study eTMF completeness.

• Oversee budget management, including Task/Change Orders, expense tracking, system/agreement consistency checks, and issue escalation.

• Provide oversight on country-specific matters, including recruitment progress, data integrity and compliance, local budgets, protocol deviations, risks, regulatory approvals, and import license status.

• Manage vendors and CROs, supervise study-specific deliverables, and ensure timely execution of delegated activities.

• Supervise eTMF setup, conduct periodic reviews, address missing documents, disseminate Safety Reports, and verify document quality.

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

• Review essential clinical documents, including Protocols and Informed Consent Forms.

• Lead the creation of study plans for assigned studies.

• Monitor study execution and progress, identifying, resolving, and escalating risks and issues as necessary.

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

• Follow up on discrepancies and grant access to new system users.

⛳️ Requirements

• Degree in Life Sciences.

• A minimum of 1 year of clinical trial experience within the realm of clinical research.

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

• Familiarity with eTMF and CTMS.

• Proficiency in English.

• Strong competency in Microsoft Office tools, including Excel, PowerPoint, Word, and Outlook.

• Knowledge of advanced Excel, timelines/budget tracking systems, and clinical trial management systems is a benefit.

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

• Exceptional interpersonal abilities.

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

🏝️ Benefits

• Stability, opportunities for career development, and a collaborative work environment.

• Annual bonuses based on the achievement of performance goals.

• Health-related benefits for employees and their families.

• Competitive retirement plans.

• Life assurance coverage.

• Varied annual leave entitlements.

• Health insurance options for employees and their families.

• Access to a Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a network of over 80,000 independent specialized professionals.

• Flexible, country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, and health assessments.

• Competitive base salary along with performance-related incentives.

• Medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Disability coverage.

• Employee assistance programs and wellness resources.

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