Clinical Project Manager

• Coordinate feasibility assessments and interactions with investigators, experts, and key stakeholders.
• Lead the preparation, start‑up, implementation, and operational oversight of clinical trials.
• Support regulatory submissions and study maintenance activities through CTIS.
• Review and oversee country‑specific study documentation to ensure regulatory compliance.
• Monitor study KPIs, metrics, and dashboards to track study performance.
• Coordinate external monitoring providers and administrative support vendors.
• Organize and lead study meetings, ensuring appropriate documentation and follow‑up of action items.
• Monitor patient recruitment, site engagement, and overall study progress.
• Identify study risks and implement mitigation plans to ensure successful delivery.
• Manage study budgets and track financial performance.
• Provide support to investigational sites through on‑site visits when required.
• Oversee study close‑out activities, including site closure, database lock, and study archiving.

Requirements

• Life Sciences , Pharmacy , Nursing , or a related scientific field.
• Previous experience as a Clinical Trial Manager, Local Study Manager, Clinical Project Manager, or equivalent role .
• Strong knowledge of clinical trial processes , including start‑up, conduct, and close‑out.
• Experience with CTIS submissions and regulatory processes in Europe.
• Good understanding of ICH‑GCP guidelines and clinical trial regulations.
• Experience coordinating CROs, vendors, and investigational sites.
• Strong project management, risk management, and budget management skills.
• Excellent communication and stakeholder management abilities.
• Fluent English (written and spoken).

Core Competencies

Demonstrates expertise in managing clinical trials, including feasibility assessments, regulatory submissions, and compliance with ICH-GCP guidelines. Proficient in project management, risk management, and budget oversight while ensuring effective communication with stakeholders.

Highest-signal resume keywords

• Clinical Trial Management
• CTIS Submissions
• Regulatory Compliance
• Project Management
• Stakeholder Management

ATS Optimization Keywords

Hard Skills

Hard Skills

• Clinical Trial Processes
• Budget Management
• Risk Management
• Study Documentation Review
• KPI Monitoring

Soft Skills

• Excellent Communication
• Stakeholder Management

Industry Keywords

• Life Sciences
• Pharmacy
• Nursing
• ICH-GCP Guidelines
• CRO Coordination

Tools & Technologies

• CTIS