Senior Clinical Trial Manager (Biotechnology, Remote)

Job summary

The role involves leading the operational planning, setup, and execution of global clinical trials, ensuring compliance with regulatory and quality standards while delivering on time. The position requires collaboration with various stakeholders to drive site feasibility and manage service providers effectively.

Qualifications

• Bachelor’s degree in life sciences or a related field; Master’s degree preferred.
• Over 8 years of experience in clinical trial management within the pharmaceutical or biotechnology sector.
• Strong understanding of ICH/GCP regulations and the clinical drug development lifecycle.
• Proven experience managing global, multi-center trials in a complex organization.
• Excellent project management and oversight skills.
• Strong communication and interpersonal skills; oncology experience is a plus.

Responsibilities

• Lead and execute global clinical trials, ensuring timely delivery and compliance.
• Oversee trial documentation, ensuring accuracy and readiness for inspections.
• Collaborate with CROs for site feasibility and activation strategies.
• Manage CROs and service providers for quality deliverables and adherence to timelines.
• Identify and mitigate operational risks using quality management approaches.
• Monitor trial performance and data quality to drive improvements.
• Foster collaboration across internal teams and external partners.

Skills

• Strong project management and service provider oversight.
• Excellent communication and collaboration abilities.
• Ability to lead without authority and mentor cross-functional teams.

Education

• Bachelor’s degree in life sciences or related field; Master’s preferred.

Tools

• Familiarity with clinical trial management systems and regulatory compliance tools.