Study Manager

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

📋 Description

• Oversee, organize, and document all site engagement initiatives for assigned clinical trials.

• Create, sustain, and proactively manage site engagement strategies, encompassing country/site-level plans, engagement frequency, and escalation procedures.

• Facilitate regular internal and external study meetings.

• Monitor and ensure the completion of necessary actions among CTLs, SELs, and cross-functional teams.

• Review and evaluate performance at the site, country, and study levels.

• Convert data into actionable insights and deliver customer-facing reports on recruitment and trial outcomes.

• Ensure thorough and precise study documentation and tracking, including engagement logs, reporting outputs, and recruitment strategies.

• Identify and address operational and recruitment risks, facilitating issue resolution and escalation.

• Act as the primary contact for site engagement, serving as a liaison between the sponsor, project management, clinical teams, and site engagement resources.

• Coordinate collaboration among Clinical Operations, Project Management, and Patient Recruitment.

• Set expectations, KPIs, and RACI roles for site engagement teams.

• Guarantee high-quality service and outputs while holding teams accountable for timelines, deliverables, and performance standards.

• Contribute to study start-up planning, resource alignment, forecasting, and the development of customer engagement strategies.

• Represent the function in customer meetings, governance forums, and strategic discussions.

• Ensure adherence to ICH/GCP and relevant regulatory, organizational, and study-specific requirements.

• Manage sensitive or complex issues and escalate as necessary.

• Undertake additional responsibilities to support effective study delivery and optimize site performance.

⛳️ Requirements

• 6–10+ years of experience in clinical trial operations, with direct involvement in site engagement, CTL, CRA, site operations, or patient recruitment functions.

• Proven experience working on global, multi-country clinical trials.

• Demonstrated ability to function effectively within matrix environments across Clinical, PM, and sponsor teams.

• Previous experience contributing to or supporting customer-facing deliverables or governance meetings.

• Strategic mindset with a strong capability to translate strategy into execution.

• Financial acumen, including budget monitoring, forecasting, and risk assessment.

• Advanced skills in data analysis and storytelling for customer reporting.

• Strong stakeholder management skills, both internally and externally.

• High level of ownership and accountability.

• Ability to drive actions and ensure accountability among teams in a matrix environment.

• In-depth understanding of clinical trial operations and site dynamics.

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

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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

• Reasonable accommodations provided during the recruitment process.