Clinical Study Manager

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

📋 Description

• Assist in the execution of designated clinical studies while adhering to ICH GCP, local regulations, and standard operating procedures (SOPs).

• Organize and implement specific tasks within assigned clinical trials.

• Collaborate with functional leads to achieve milestones and fulfill project objectives.

• Supervise the selection of CROs/vendors, budget and contract negotiations, and performance of Strategic Partners.

• Raise issues to governance committees as necessary.

• Review and approve monitoring documents and plans, as well as assess monitoring outputs, decisions, and actions.

• Conduct Oversight Monitoring Visits when required.

• Review and endorse pertinent study plans.

• Manage and participate in study team meetings, overseeing agendas and minutes.

• Analyze protocol deviation outcomes and actions to identify trends across different sites and studies.

• Monitor issues, risks, and decisions at the study level and apply mitigation strategies.

• Take ownership of and review trial operational data, including data from the Clinical Trial Management System (CTMS).

• Provide oversight of internal trial reports.

• Ensure studies are prepared for inspections and assist with regulatory audits.

• Prepare for agency inspections by ensuring document readiness, tracking, and developing storyboards.

• Support data review for database lock and the writing and review of Clinical Study Reports (CSR), including appendices.

• Collect, review, and organize study documents for the trial master file and regulatory submissions.

⛳️ Requirements

• Over 5 years of experience in the pharmaceutical industry and/or clinical research organizations.

• More than 3 years of clinical study management oversight, including substantial study management support experience as a Project Manager/CTM on a global scale.

• Experience in early-phase clinical studies or Phase 2 and 3 studies.

• Experience in conducting global/international studies or programs.

• Experience across multiple therapeutic areas is a plus.

• Proven ability to successfully manage projects within defined scope, timeline, and budget constraints.

• Experience in vendor selection and oversight.

• Strong leadership and organizational abilities.

• Excellent communication and interpersonal skills.

• Comprehensive knowledge of global regulatory and compliance requirements, including US CFR, EU CTD, and ICH GCP.

• Awareness of local country requirements may be necessary.

• Proficient in project management tools and methodologies.

• PMP or PRINCE2 certification is a plus.

• Detail-oriented, proactive, and adaptable.

• Fluent in business English, both oral and written.

• Legal authorization to work in Poland.

🏝️ 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 assurance and disability coverage.

• Employee assistance programs and wellness resources.

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