Clinical Trial Manager (Biotechnology, Remote)

Job summary

The role involves overseeing the planning, execution, and management of global clinical trials, ensuring compliance with timelines, quality standards, and regulatory requirements. The position requires collaboration with various stakeholders to facilitate trial processes and maintain documentation.

Qualifications

• Bachelor’s degree in life sciences or a related field; Master’s degree preferred.
• Over 5 years of experience in clinical trial management within the pharmaceutical or biotechnology sectors.
• Strong understanding of ICH/GCP regulations and the clinical drug development lifecycle.
• Proven experience managing global, multi-center trials in a complex organizational structure.
• Project management skills and experience in overseeing service providers.
• Effective communication and interpersonal skills.
• Experience in oncology or specific therapeutic areas is highly desirable.

Responsibilities

• Plan, set up, and execute global clinical trials, ensuring adherence to timelines and quality standards.
• Maintain accurate documentation and participate in inspection readiness activities.
• Collaborate with CROs and internal teams for site feasibility, selection, and management.
• Oversee service providers, tracking deliverables and ensuring alignment with study expectations.
• Identify and mitigate risks throughout the trial lifecycle.
• Manage protocol deviations and trial-level issues, ensuring proper documentation and follow-up.
• Review trial data and track performance, contributing to reporting and issue identification.
• Build strong relationships within a global, matrixed team environment.

Skills

• Strong project management and organizational skills.
• Excellent communication and collaboration abilities.
• Ability to work effectively in a dynamic, fast-paced environment.

Education

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

Tools

• Familiarity with clinical trial management systems and relevant software tools.