Senior Clinical Study Manager

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

📋 Description

• Serve as the line manager for Clinical Study Managers within the designated country or countries.

• Plan, assign, and oversee work; evaluate performance; and support the professional development of direct reports.

• Assign staff to clinical research projects according to their experience and training.

• Ensure that clinical trial protocols and activities comply with ICH guidelines, GCP, local regulations, and relevant SOPs.

• Collaborate with regional and country teams to uphold study timelines and quality benchmarks.

• Provide support for clinical trials in the country and offer local expertise.

• Promote best practices, process enhancements, and operational efficiency.

• Lead, manage, mentor, recruit, onboard, train, and assess Clinical Study Managers.

• Oversee resources, workload, quality metrics, follow-ups, issue resolution, and stakeholder reporting for CSMs.

• Facilitate CSM forums and endorse initiatives aimed at enhancing clinical trial delivery.

• Advocate for quality, risk management, knowledge management, continuous improvement, innovation, and operational excellence.

• Review and assist in the development of study start-up templates, drug labels, informed consent forms, and other relevant documents.

• Anticipate and address site-related issues, recommend corrective and preventive actions, and contribute to clinical operations strategy.

• Conduct regular one-on-one meetings, performance evaluations, reviews, and goal tracking.

• Manage functional service provider personnel and coordinate with FSP leadership and line managers.

⛳️ Requirements

• Understanding of clinical trial execution and ICH/GCP standards.

• Strong knowledge of clinical operations.

• Competencies in organizational, project management, and leadership skills.

• Ability to effectively prioritize tasks.

• Excellent written and verbal communication skills.

• Highly organized with diligent follow-through.

• Skills in risk mitigation.

• Experience in line management.

• Knowledge and/or experience with the Functional Service Provider model.

• Experience in mentoring and training.

• Proficiency in Microsoft Office applications, including Outlook, Word, Excel, PowerPoint, and Teams.

• Capability to ensure compliance with clinical trial processes, SOPs, local regulations, ICH guidelines, and GCP.

🏝️ Benefits

• Occasional travel.

• Equal opportunity employment.