Clinical Trial Manager (Biotechnology, Remote)

Job summary

This 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 support trial activities and maintain documentation for inspection readiness.

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 knowledge of ICH/GCP regulations and the clinical drug development lifecycle.
• Experience managing global, multi-center trials in a complex organizational structure.
• Proven project management and service provider oversight capabilities.
• Excellent communication and interpersonal skills.
• Experience in oncology or specific therapeutic areas is highly desirable.

Responsibilities

• Plan, set up, and execute global clinical trials while adhering 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 with proper documentation and follow-up.
• Review trial data and track performance to identify potential issues.
• Foster strong relationships within a global, matrixed team environment.

Skills

• Strong project management and organizational skills.
• Ability to work collaboratively in diverse teams.
• Proficient in risk management and quality assurance processes.

Education

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

Tools

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